Syneos Health

Leading and managing client portfolios, developing operational strategies, and ensuring project delivery within the CRO/pharma industry. | Requires extensive experience in real-world late-phase research, CRO/pharma industry, and managing complex client accounts, with strong financial and operational expertise. | Job Description: • Providing overall leadership and strategic direction to Project teams. • Subject matter expert for operations strategies • Serve as SME, translates and executes strategies as defined by clients and leadership. • Works with leadership to develop strategy for area of responsibility. • Develops operations strategies from deep understanding of broad client strategic needs representing RWLP within large accounts • Ensuring cost-effective integrated solutions are presented consultatively to our clients to successfully address their peri- and post-approval evidentiary needs • Accountable for ensuring delivery of one or more books of work from RWLP-managed account(s) • Works with assigned clients to identify their RWE needs and ensure that these are understood and acted upon directly through the RWLP BU or through collaboration with other BUs • Leads discussion with clients, to articulate and position RWLP business unit operational processes, peri- and post-approval research standards. • Maintains senior management-level relationships with clients via routine meetings (e.g., 1:1’s with counterparts) • Provides oversight to project management teams in driving management of financial aspects of assigned projects to ensure adherence to the whole financial process flow • Enable a culture of proactive risk identification and mitigation, rapid issue resolution, a sense of urgency, customer satisfaction and stakeholder collaboration. Requirements: • Bachelor’s degree in life sciences or equivalent (e.g., BSc, BS) • Advanced / Professional degree in life sciences or business management preferred (e.g., MSc, MPH, PhD, MD, MBA) • At least six (6) years - Eight (8) years managing studies. • At least six (6) - eight (8) years RWLP experience • Previous Real World Late Phase CRO/pharma experience in peri- and post-approval research, with increasing levels of positional responsibility and portfolio/client/account complexity • Proven ability to work independently across multiple accounts • navigates complex Stakeholder structures (internal and external) • proactive problem solving for portfolio delivery and financial impact mitigation plans • Virtual/decentralized study experience preferred • Prior cross-functional project management experience within the CRO/Pharma industry is required • A track record for successful management and delivery of client portfolios • Direct experience with account / client (vendor) management, including RFP/proposal development, Bid Defenses, Capabilities presentations • Strong knowledge of the end-to-end life product cycle development process • Solid business and financial acumen, including experience with contractual negotiations • Demonstrated ability to drive strategic operations decisions involving multiple stakeholders • Global and diversity-oriented people management experience including line management and matrix management. • Flexibility, with the ability to handle multiple tasks to meet deadlines delivering high quality work in a dynamic, rapidly changing environment. • Strong interpersonal and communications skills as well as a proven team-oriented approach. • Strong working knowledge of real-world operational and regulatory requirements • Proficiency in virtual communications and Microsoft Office Suite (Word, Excel, and PowerPoint) • Excellent written and spoken English. Benefits: • career development and progression • supportive and engaged line management • technical and therapeutic area training • peer recognition and total rewards program

Lead the restructuring, scaling, and commercialization of the RWE and RWLP business, including defining solutions architecture, managing organizational change, and developing market strategies. | Over 12 years of experience in business strategy, transformation, or portfolio management within global organizations, with strong leadership and communication skills, preferably with healthcare or data services sector experience. | Executive Director, Product Development Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Executive Director, Real World Strategy & Solutions Product Development About the Role The Executive Director, RWE & RWLP Growth Strategy & Solutions Product Development, will serve as the strategic and operational leader responsible for restructuring, scaling, and commercializing the Real World Evidence (RWE) and Real World Late Phase (RWLP) business. This leader will architect the future portfolio of offerings, define the long-term growth strategy, and build the organizational infrastructure required for sustainable expansion. A critical mandate of this role is to capture, codify, and operationalize the deep expertise currently held by Subject Matter Experts (SMEs), operational leaders, and proposal development teams, transforming tacit knowledge into accessible, repeatable, scalable solutions and tools. This ensures that Syneos Real World offerings are clearly differentiated, commercially viable, and deliverable by teams at scale, regardless of individual personnel changes. This leader must bring a strong background in Strategy, Transformation, Operational Excellence, and Solutions/Product Architecture across complex, global organizations. Reporting Structure Reports to: VP, Real World Late Phase Key Responsibilities 1. Business Transformation & Organizational Leadership • Lead the design and execution of the organizational and service transformation necessary to scale the RWE and RWLP business. • Oversee commercial priorities, go-to-market strategies, investment proposals, and enterprise-level change management initiatives. • Build a robust operational foundation that allows the business to stand independently—resilient, replicable, and not dependent on individual SMEs. 2. Solutions Product Development & Knowledge Infrastructure • Define the architecture for all RWE and RWLP solutions, ensuring offerings are modular, differentiated, scalable, and grounded in clear commercial and operational requirements. • Identify gaps in existing tools, processes, and expertise; facilitate the work of SMEs to fill those gaps. • Translate SME knowledge into standardized tools, templates, frameworks, and playbooks. • Ensure offerings clearly articulate differentiators, value propositions, and delivery models. 3. Strategic Prioritization of the Service Portfolio • Review and radically prioritize the current portfolio for scalability and commercial viability. • Redirect investment away from low-growth offerings toward high-potential products and markets. • Develop future-focused offerings aligned with market needs and Syneos Real World's growth ambitions. 4. Future Opportunity Mapping & Market Strategy • Own the long-term growth map for RWE & RWLP. • Develop market entry strategies, pricing models, and competitive deal frameworks. • Partner with BD and SMEs to ensure consistent, competitive proposal development. 5. Cross-Functional Leadership & Operational Integration • Lead cross-functional working groups to bring offerings from concept to launch. • Ensure alignment across commercial, operational, delivery, finance, scientific, and quality functions. • Support SME hub development and ensure succession and depth of expertise across service lines. 6. Market Enablement & Sales Empowerment • Develop a sophisticated go-to-market strategy encompassing training, pricing, and solution positioning. • Ensure the global sales team is fully enabled with solution narratives and commercialization tools. • Partner with Commercial leadership to standardize proposal content and elevate win probability. 7. Risk Reduction, Transparency & Business Maturity • Build transparency into costing, budgeting, operational planning, and solution delivery. • Reduce business fragility by documenting and standardizing processes and expertise. • Drive cross-training strategies to upskill PDs and delivery teams to SME-level performance. Qualifications & Requirements • Minimum 12+ years of progressive business experience, with at least 5 years in a leadership role focused on Strategy, Business Transformation, or Portfolio Management within a global services or consulting environment. • Demonstrated success leading complex organizational change and achieving ambitious targets. • Proven ability to simultaneously manage commercial and operational strategies in complex, high-value service lines across a matrixed organization. • Exceptional executive-level communication and presentation skills, with the ability to influence C-suite stakeholders internally and externally. • Experience in the CRO, Pharma/Biotech, or Healthcare Technology sector. • Familiarity with RWE, RWLP, or data services is beneficial but secondary to the core transformation skillset. • MBA or equivalent higher education degree preferred. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.

Lead clinical data collection, cleaning, and quality oversight for complex studies, ensuring data integrity and compliance. | Minimum 10 years in Clinical Data Management or Data Science, with project management experience, and proficiency in data analysis tools like Python, R, SAS. | Principal Clinical Data Scientist- Data Managment Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Summary The Principal Clinical Data Scientist provides strategic and operational leadership for end-to-end clinical data collection, cleaning, and quality oversight across complex clinical studies. This role serves as the functional lead for Clinical Data Science, ensuring clinical data deliverables are fit for purpose, compliant with regulatory and contractual requirements, and aligned with sponsor expectations and study timelines. The position partners cross-functionally to drive data quality, risk mitigation, analytics innovation, and timely delivery of clinical data milestones. Responsibilities Serve as the Functional Lead for Clinical Data Science on complex, multi-scope clinical projects and act as the primary liaison between Clinical Data Science, Project Management, Clinical Monitoring, and other functional groups. Act as the central steward of clinical data quality through holistic review of clinical and operational data using detailed protocol and therapeutic area knowledge. Ensure required data elements and corresponding data quality oversight steps are identified to support defined study analyses. Coordinate cross-functional data cleaning activities to meet quality standards, timelines, and contractual obligations. Communicate, troubleshoot, and resolve complex data-related issues; recommend solutions and escalate issues impacting patient safety, data integrity, or study analysis. Develop Clinical Data Acquisition Plans and data flow diagrams for complex studies and align data flow with study protocols, regulatory requirements, and study endpoints. Assess risks related to protocol design, program-level strategies, and study parameters that may impact data credibility and trial reliability. Design and drive development of analytical tools and dashboards to identify potentially unreliable or high-risk data. Perform analytic reviews as defined in the scope of work and data acquisition plans; identify root causes and implement systematic resolutions. Demonstrate understanding of advanced technologies and assess their applicability to individual studies or programs. Monitor and communicate project progress using status reports, tracking tools, and metrics to Sponsors and internal teams. Ensure launch, delivery, and completion of Clinical Data Science milestones in compliance with contracts, SOPs, guidelines, and regulatory requirements. Collect and analyze metrics to support continuous process improvement initiatives. Review and manage Clinical Data Science budgets, identify out-of-scope activities, and initiate change orders through Project Management. Plan, manage, and allocate Clinical Data Science resources and coordinate the work of assigned team members. Develop and maintain project plans, specifications, and documentation in compliance with SOP requirements. Maintain ongoing documentation and ensure Trial Master File (TMF) completeness and accuracy. Participate in and present at internal, Sponsor, investigator, and third-party meetings. Provide input to proposals, bid defenses, and RFP responses and promote new Clinical Data Science business opportunities aligned with Sponsor strategies. Prepare documentation for and participate in internal and external audits. Train and mentor junior team members and maintain proficiency in Clinical Data Science systems through ongoing training. Perform other duties as assigned. Qualifications Education Bachelor’s degree in Biological Sciences, Computer Science, Mathematics, Data Science, or related discipline required. Master’s degree preferred. Equivalent relevant experience may be considered in lieu of degree. Experience Minimum of 10 years of experience in Clinical Data Management and/or Clinical Data Science. At least 5 years of project management experience. Experience with Clinical Data Science practices and relational database management systems. In-depth knowledge of the drug development lifecycle, including risk-based data quality approaches and biometrics workflows. Skills & Knowledge Expertise in protocol interpretation, data collection strategies, and data cleaning specification development. Strong analytical modeling skills including regression, classification, and clustering; AI/ML experience preferred. Experience with data analysis, data review, and visualization tools including Python, R, SAS, and Spotfire. Knowledge of ALCOA++ data quality principles. Knowledge of medical terminology, clinical trial data, and ICH/GCP regulatory requirements. Proficiency with Microsoft Word, Excel, PowerPoint, email, and Windows-based applications. Strong leadership, communication, organizational, and time-management skills. Ability to manage multiple priorities in a fast-paced, dynamic environment. Ability to work independently and collaboratively across multidisciplinary teams. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $95,000.00 - $175,700.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.

Lead and coordinate medical writing activities for clinical study documents ensuring regulatory compliance and scientific accuracy. | 3-5 years of relevant medical or scientific writing experience in biopharmaceuticals, strong understanding of FDA and ICH regulations, and proficiency in medical document types. | Senior Medical Writer Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Leads the resolution of comments from the client. Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget. Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads team document reviews, and reviews documents as needed. Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Provides feedback to further define statistical output required and document needs. Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. Performs online clinical literature searches and complies with copyright requirements. Identifies and proposes solutions to resolve issues, escalating as appropriate. Provides technical support, training, and consultation to department and other company staff. May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities. Mentors and leads less experienced medical writers on complex projects, as necessary. Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing. Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership. Completes required administrative tasks within the specified timeframes. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Qualifications: 3-5 years of relevant experience in science, technical, or medical writing. Experience working in the biopharmaceutical, device, or contract research organization industry required. Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required. Experience writing relevant document types required. Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.

Supports financial reporting, budgeting, forecasting, and project analysis for business units, ensuring accuracy and timeliness. | Bachelor's degree in Business, Finance, or related field; 0-2 years of experience; proficiency in Microsoft Office and familiarity with Oracle Finance preferred. | Project Financial Analyst II Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Job Summary Serves as financial analyst for Business Unit Controller(s) and Associate Director(s) Finance. Prepares, reconciles, analyzes and reports Business Unit(s) revenue, contracts, projects, and associated metrics. Produces financial and other business analyses, interpretation, and investigation of data for operations for assigned projects and contracts. Ensures all reporting activities are accurate and prepared within established timelines. Core Responsibilities 1. Supports Business Unit Controller in: 2. Records revenue each month for Unit, Fee for Service and Fixed Price contracts; 3.Loads project budgets into Oracle/Revenue Wizard and maintaining key member lists (project set up) and other project data in Oracle and associated systems and schedules; 4. Drafts project level actual versus budget/forecast variance analysis monthly as well as monthly reports for distribution in analyzing monthly results; 5. Drafts monthly forecasting of financial results (backlog); 6. Meets established deadlines for Revenue and Backlog submittals; 7. Timely preparation of project close out reconciliations; 8. Reviews, with assistance, executed Work Orders and Change Orders for bonus or other anomalies. 9. Works closely with Business Unit Controller to: 10. Captures, assesses and consolidates results; and 11. Drafts key reports such as annual cost and expense budgets, cost rates, cost and expense forecasting, monthly utilization, headcount, revenue backlog analysis, and/or gross profit for assigned area. 12. Updates predefined reports. 13. Attends project meetings as applicable to support assigned areas. Attends project kick-off meetings to capture and process relevant data for set up of newly awarded projects onto financial systems and schedules. Attends monthly project review (MPRs) meetings to ensure understanding/concurrence of project status, potential issues and the accuracy of the forecast. 14. Monitors the overall health of assigned projects including but not limited to revenues, gross profit, receivables, and unbilled amounts as well as project close outs and reconciliations. Qualifications Education Requirements Min/Preferred Education Level Description Minimum 4 Year / Bachelors Degree BA/BS degree in Business, Accounting, Finance, or equivalent education and experience. Additional Qualifications • Pharmaceutical or CRO experience preferred. • Strong English proficiency. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) is essential. • Proficiency with accounting software packages. • Experience with Oracle Finance is preferred. • Exceptional attention to detail, accuracy, organizational, interpersonal, and teamwork skills. • Excellent financial, communication, and interpersonal skills as well as a high level of personal motivation to achieve. • Demonstrated ability to work with confidential and sensitive data. • Ability to perform several tasks simultaneously to meet deadlines is necessary. Critical Skills Disclaimer Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. US ONLY Years of experience required Minimum of zero to two (0 - 2) years of related experience Physical Requirements: Position requires: ability to occasionally move about inside the office to access filing cabinets, office equipment, etc. and to move between office locations; ability to maintain a stationaryposition for prolonged periods of time; ability to occasionally manipulate (e.g., lift, carry, move) office items and packages of light to medium weights of 10-35 pounds; ability to constantly operate a computer and other office productivity equipment (e.g., scanner, phone, printer, copier); ability to perceive and assess written materials for prolonged periods of time; and ability to frequently communicate with colleagues on the phone, by email, and in-person. Work Environment: This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. The noise level in the work environment is low. This is a largely sedentary role. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $56,400.00 - $95,900.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.

Provides medical oversight for clinical studies, develops protocols, and supports regulatory and scientific activities. | Doctorate in medicine with clinical research experience, in-depth knowledge of FDA and international drug development regulations, and strong communication skills. | Medical Director - Psychiatry Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities • Provides medical oversight of assigned clinical studies in the duty as a medical monitor. Often serves as primary medical contact for customers for assigned clinical studies. • Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department. • Responsible for protocol design and development, upon request. Provides input into protocol amendments. • Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed. • Provides medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification efforts. This activity includes, but is not limited to, review of Informed Consent Templates and Subject-Facing Materials, and input into site feasibility evaluations. • Provides medical input into data collection tools, monitoring plans, and review and analysis plans. • Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data. Presents identified trends and issues, and mitigation strategies, to customers and project team members to minimize risks to subject safety or integrity of study data. • Provides after-hours medical coverage for clinical studies. • Adheres to all enterprise policies, work instructions, standard operating procedures, and project plans. Adheres to customer policies and standard operating procedures, as required in project plans. • Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines. • May support responses to Requests for Proposals (RFPs) or Bid Defense Meetings (BDMs), upon request. • May provide input to clinical development or regulatory teams within the Company, upon request. • May represent the Company at scientific meetings, upon request. Doctorate degree in medicine and clinical experience in the practice of medicine in the specific therapeutic area. Clinical research experience required. • Candidate must have in depth knowledge of FDA and worldwide drug development regulations. A strong understanding of the use of medical terminology and of drug names in multiple nations and environments is required. Experience working in matrix teams is preferred. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Effective organizational and interpersonal skills, communication and language skills, and group presentation skills. Above average attention to detail, accuracy, organizational, interpersonal, and team-oriented skills. Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential. Ability to be customer-focused and have a disciplined approach to work is critical. Fluency in written and spoken English is essential. Up to 25% travel may be required. Minimum of three (3) years of clinical research experience with seven (7) or more years of combined medical and clinical research experience At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.

Lead and manage clinical development projects ensuring compliance with regulatory standards, coordinate teams, manage contracts and finances, and communicate project status to stakeholders. | Experience managing large-scale projects with minimal supervision, knowledge of Good Clinical Practices (GCPs), regulatory compliance, strong leadership, and communication skills. | Project Manager II - Sponsor Dedicated (North America-based) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities • Acts as a primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer's and Company's contractual agreement. Ensures the project is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. • Serves as the team leader by overseeing the project team. Facilitates team building and communication. Acts as a liaison and facilitator between other departments within the Company for project related tasks and/or issues. Proactively monitors project resources and works with functional lead/management to ensure project requirements are met. • Manages large scale projects encompassing various solutions ranging in complexity from single service regulatory and/or medical writing projects to large full scope multi-year projects, global projects and/or programs, with minimal interaction from supervisor. This includes proactive operational and financial management of tasks, risk, escalations, and quality from start-up through final deliverable. • Manages the executed contract and financial aspects of assigned projects/programs. Completes monthly review of tasks completed and backlog. Ensures customers are notified of out-of-scope items in a timely manner. • Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports. Ensures adequate documentation of each communication. • Independently prepares information for internal review meetings and proactively manages action resolution to ensure project delivery. • Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Produces and distributes status and tracking reports as well as functional area plan, to appropriate team members and senior management. • Explores and champions new ideas for process and efficiency enhancements. • Networks to acquire new and/or repeat business across all regulatory and medical writing services. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $79,800.00 - $139,600.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Manage interdisciplinary clinical research projects ensuring compliance with GCP and regulatory requirements, lead project teams, oversee budgets and timelines, maintain study documentation, and coordinate with clients and partners. | Bachelor's degree or equivalent in life sciences or related field, CRO and therapeutic area experience preferred, strong knowledge of GCP/ICH guidelines, organizational and communication skills, and ability to travel approximately 25%. | Description Clinical Project Manager II - post-trial access / EAP / rollover studies Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Project Leadership and Delivery: • Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements. • Acts as a primary liaison between the Company and the Customer to ensure timely study launch,conduct, and closeout according to the Customer’s and the Company’s contractual agreement. • Lead project team to ensure quality, timelines and budget management. • Accountable for the financial performance of each project. • Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues. • Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements. • Accountable for all project deliverables for each project assigned. Documentation and Reporting: • Responsible for quality and completeness of TMF for assigned projects. • Accountable for maintenance of study information on a variety of databases and systems. • Responsible for study management components of inspection readiness for all aspects of the study conduct. • Oversight for development and implementation of project plans. • Plan, coordinate and present at internal and external meetings. • Prepare project management reports for clients and management. • Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals. Business Development: • Develops strong relationships with current clients to generate new and/or add-on business for the future. • May participate in bid defense meetings where presented as potential project manager. Management: • May be required to line manage other project management team members and clinical monitoring staff. Qualifications • Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience. • Clinical research organization (CRO) and relevant therapeutic experience preferred. Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements • Strong organizational skills. • Strong ability to manage time and work independently. • Direct therapeutic area expertise. • Ability to embrace new technologies. • Excellent communication, presentation, interpersonal skills, both written and spoken. • Ability to travel as necessary (approximately 25%). Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Lead and manage complex medical writing projects ensuring documents meet regulatory and sponsor requirements, provide training and mentorship to medical editors, and perform copyediting and data integrity reviews. | Bachelor’s degree or equivalent experience in life sciences or related fields, strong copyediting and data integrity skills, familiarity with AMA style guide, knowledge of FDA/EU regulations, and ability to manage multiple projects independently. | Description Principal Medical Editor, Regulatory - Sponsor Dedicated (Home-based, Pacific Time Zone) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities • Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. • Represents the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed. • Monitors timelines and budgets for assigned projects and updates the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk. • Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on data integrity review, compilation, publishing, and editorial standards. Provides training to members of the global Medical Writing team in aspects relative to their roles. • Project lead for deliverables of assigned complex and/or large medical writing projects, including but not limited to scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring that all information is distributed to the editorial team and implemented within the deliverable. • Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of document editorial process. • Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following American Medical Association (AMA) or various custom style guidelines as well as established medical writing internal checklists and best practices. • Performs data integrity review of assigned documents to ensure accuracy. • Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work. • Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget. • May compile and publish medical writing deliverables. Qualifications • Bachelor’s degree (preferred) in the life sciences, clinical sciences, or English/journalism; or copyediting, data integrity review, and/or relevant publishing experience. • Significant relevant publishing experience using Adobe Acrobat or other appropriate markup language preferred; ISIToolbox experience preferred. • Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). • Excellent attention to detail, including strong copyediting, data integrity review, accuracy, problem solving, organizational, interpersonal, presentation, project management, and team-oriented skills. • Excellent grammatical and communication skills, both written and oral. • Extensive familiarity with the AMA style guide strongly preferred. • Ability to work with minimal supervision on multiple assignments with set deadlines. • Ability to work independently as well as part of a team and keep others informed of the progress and status of projects. • Adaptable to changes in work duties, responsibilities, and requirements. • Knowledge of FDA and EU requirements, ICH regulations and ISO standards as applicable to regulatory documents preferred. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Manage and lead a multifunctional clinical research team ensuring customer delivery, compliance, performance management, and resource allocation. | Bachelor’s degree or equivalent, extensive clinical research experience including leadership, knowledge of GCP/ICH guidelines, strong communication and organizational skills, and ability to travel. | Description Manager, FSP 360 Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Responsible for interacting and engaging with internal and external stakeholders for functional team members, acting as a Syneos Health ambassador with customers. Responsible for managing team members’ performance in line with project deliverables. Accountable for direct supervision of FSP360 multifunctional staff. Overall, the role will be responsible for three primary performance areas: • Customer Delivery and Success • Responsible for direct interaction with the customer points of contact (s) (PoC) on service delivery for their team members (direct reports). Develops and fosters strong, collaborative relationships with customers at a local level, promoting high levels of trust and satisfaction • Manages performance and daily activities of multifunctional team members to excel in service delivery and compliance with agreed-upon KPIs; develops and executes mitigation and remediation plans for non-compliance as needed • Participates in managing the resource availability for their team members to ensure they are suitably resourced and resource needs are identified in a timely fashion; resolves potential resourcing conflicts to facilitate mutually beneficial resolutions • Solicits feedback from customer PoC (s) for continuous improvement of service delivery and to strengthen customer relationships • Proactively communicates and manages customer issues through assigned escalation channels • Ensures quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) and compliance with federal and local guidelines and ICH GCPs • May conduct oversight visits as required for Clinical Research Associates • Responsible for all system updates, and compliance to systems and relevant procedure and practices applicable to the customer and Syneos Health processes • Business Impact • Proactively discusses resource needs with customers, driving growth at a local account level • Makes informed and data-driven decisions of their team members that result in positive impact on overall business unit performance • Listens to customer and shares knowledge across the business unit in order to disseminate best practices and lessons learned in support of the overall FSP 360 operating model • Drives revenue by attracting, selecting and retaining the right talent • Continues to assess and places talent on projects leveraging core competencies, margin impact and alignment to customer requirements • Attends and participates in FSP360 account meetings as well as regional management team meetings and Town Halls • People Leadership • Provides line management to FSP360 team members • Responsible for active management of team members’ performance through the established Syneos Health process, including goal setting, mid-year reviews, year-end evaluations and implementation of performance improvement plans as necessary • Verifies that team members adhere to training guidelines, maintain their training records and individual and corporate training needs are identified and addressed • Provides administrative oversight (for example, HR processes, timecards, expense reports) • May be involved in assignment of project work and will review workload and utilization for all their team members • Supports team members’ professional development through coaching, providing opportunities to increase knowledge and skill levels, and by delegating tasks commensurate with skill level. Supporting and advocating for team members to develop their Individual Development Plans • Proactively works to ensure team members’ engagement, retention and turnover rates remain within expected levels. Recognizes team members while encouraging a culture of accountability • Demonstrates commitment to diversity, equity and inclusion through continuous development of all staff, modeling inclusive behaviors and proactively managing bias Qualifications • Bachelor’s degree in life sciences, nursing degree, or equivalent related experience, plus extensive clinical research experience in a contract research organization, pharmaceutical or Biotechnology Company, including some time in a leadership capacity or equivalent combination of education, training and experience is required. • Extensive knowledge of GCP/ICH guidelines and other applicable regulatory requirement • Excellent communication, presentation, interpersonal skills; both written and spoken, with an ability to inform, influence, convince, and persuade. • Strong time management, technical and organizational skills. Ability to work independently and within a team environment. • Creative problem solver who is self-motivated, flexible, open to change, collaborative, and possesses a customer-centric mindset • Knowledge of basic financial concepts as related to forecasting and budgeting. • Must demonstrate good computer skills and be able to embrace new technologies • Ability to travel as necessary (up to 25%) At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range $79,800.00 - $139,600.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Develop and maintain R-based data visualization apps, mentor biostatisticians, support statistical analysis and programming for clinical trials, and ensure quality and compliance of statistical deliverables. | PhD/MS in biostatistics or related field, 2+ years pharma/biotech statistician experience, expert in R and R-Shiny, knowledge of advanced programming and cloud technologies, strong communication skills. | Description Principal Biostatistician (Rshiny - EMEA & US BASED) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities • Please submit all CVs in English • Must be located in US, UK, Ireland, Poland, Spain, Greece, Hungary, Belgium, Romania, Ukraine, South Africa, Argentina, Mexico, Brazil, or Columbia. Principal Biostatistician - RShiny Specific Sets up and maintains excellent R-based computing environment. Adds missing features to apps and fixes bugs in existing apps. screens the market for supplied data visualization tools and integrates internal/external apps into our working environment. Organizes and performs user trainings and is available for user support on demand. Is up to date with the latest technical possibilities available on the global market. Excellent R and R-shiny knowledge thorough experience in clinical data structures and programming with data expert in functional and object-oriented programming. Knowledgeable in Javascript/Typescript, HTML, WebGL, experience in CUDA/GPU-programing, cloud-computing, Github, web-hosting/ Machine Learning. Strong communication skills and ability to work both, independently and collaboratively, clear in the presentation of complex issues. Job Responsibilities • Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates. Conducts training sessions, or otherwise trains new hires and enhance the skills of existing personnel. • Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department. • Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR. • Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborates with sponsor, if required. • May be responsible as Lead Biostatician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report. • Creates or reviews programming specifications for analysis datasets, tables, listings, and figures. • Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis. • Implements company objectives, and creates alternative solutions to address business and operational challenges. • As biostatistics representative on project teams, interfaces with other departmental project team representatives • Preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others. • Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistent with analysis described in the SAP and specifications. • May lead complex or multiple projects (e.g. submissions, integrated analyses), and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor. • Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study related activities with biostatistics management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines. • Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalates to management. • Provides statistical programming support as needed. • May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician. May serve as a voting statistician on DSMBs and/or DMCs. • Provides input and reviews, and subsequently follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness. • Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business. • Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others • Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. • Performs other work-related duties as assigned. • Minimal travel may be required. Qualification Requirements • Previous Rshiny experience is required for this role. • PhD or MS in biostatistics, statistics, mathematics or data scientist with a strong emphasis on computing/informatics. • At least two years of experience as statistician with significant time spent in the Pharma, Biotech, or similar sector • Excellent R and R-shiny knowledge thorough experience in clinical data structures and programming with data • Expert in functional and object-oriented programming knowledgeable in Javascript/Typescript, HTML, WebGL • Experience in CUDA/GPU-programing, cloud-computing, Github, web-hosting • Strong communication skills and ability to work both, independently and collaboratively, clear in the presentation of complex issues • Team player • Fluency in English Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Principal Biostatistician - RShiny Specific: Sets up and maintains excellent R-based computing environment. Adds missing features to apps and fixes bugs in existing apps. screens the market for supplied data visualization tools and integrates internal/external apps into our working environment. Organizes and performs user trainings and is available for user support on demand. Is up to date with the latest technical possibilities available on the global market. Excellent R and R-shiny knowledge thorough experience in clinical data structures and programming with data expert in functional and object-oriented programming. Knowledgeable in Javascript/Typescript, HTML, WebGL, experience in CUDA/GPU-programing, cloud-computing, Github, web-hosting. Strong communication skills and ability to work both, independently and collaboratively, clear in the presentation of complex issues.

Manage site oversight, clinical and central monitoring, ensure patient safety and regulatory compliance, coordinate with clinical teams, and oversee deliverables and risk mitigation. | Bachelor's degree, 3+ years clinical trial management experience, knowledge of clinical research processes and regulations, strong project management and communication skills, proficiency with clinical trial software, and preferably CCRP certification. | Description Clinical Trial Manager I Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities • Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. • Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities. • May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT). • Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters. • Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. • Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope. • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations. • Participates and presents in key meetings such as Kick Off Meeting. • Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. This may include accompanying CRA team members to sites for observation or conflict resolution. • Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data • Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities. • Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. Ensures access and audit trail reviews are conducted as required. • Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study. • Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality. • Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and /or tracking tools. • Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan. • Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans. • Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. Document requested revisions and approvals in CTMS. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines. • Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables. Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements. Provides solutions for obstacles in protocol execution and site management. • Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations. This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA). Supports Inspection Readiness for clinical trial management scope. • Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks. May develop and support execution of corrective action plans at site and study level. Supports and completes activities to achieve data cut and lock deadlines. • Provides feedback to line managers on staff performance including strengths as well as areas for development. Qualifications • Bachelor's degree in a related field (e.g., life sciences, clinical research) • Minimum of 3 years of experience in clinical trial management or a related field • In-depth knowledge of clinical research processes and regulations • Strong project management and organizational skills • Excellent communication and interpersonal skills • Ability to work independently and as part of a team • Proficiency in using clinical trial management software and tools Certifications • Certified Clinical Research Professional (CCRP) or equivalent certification preferred Necessary Skills • Strong analytical and problem-solving skills • Attention to detail and accuracy • Ability to manage multiple projects and priorities simultaneously • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) • Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within the Clinical Trial Management job family at the P22 level. The Clinical Trial Manager I (CTM I) serves as the clinical functional lead, accountable for the delivery of site management, clinical monitoring and central monitoring of assigned study(ies). A CTM I is expected to independently manage the clinical and central monitoring team members but may serve as a regional clinical lead on larger trials under the direction of a global Sr CTM. The position as defined by scope provides leadership, problem-solving, mentoring, and technical support to the Clinical Operations team to ensure compliance with the monitoring plan as well as ensures timeliness and quality of deliverables within the specified budget.

Develop regulatory submissions and provide post-marketing regulatory support, including writing, research, compliance, and client advisory. | Senior level experience in regulatory submissions and compliance, strong writing and research skills, ability to manage smaller projects and support business development. | Description senior regulatory consultant Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Responsible for the development of regulatory submissions and post marketing regulatory support for clients. This includes authorship of portions of regulatory submissions, regulatory writing, regulatory research, and ensuring compliance with relevant guidelines and standards. Responsible for providing advice and assistance to clients and other associates in areas of expertise and may manage smaller client projects. Supports new business development in area of expertise. At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Regulatory Submission Manager within the Vertex Regulatory Operations team.

Manage and prepare regulatory submissions and documentation, support regulatory agency interactions, and ensure compliance with global regulatory requirements. | Requires previous CMC experience, ability to manage regulatory submissions, support audits, and work within EST time zone. | Description Regulatory Consultant CMC Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities For non-complex and complex submissions, independently fulfill the following responsibilities: • Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions. • Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance. Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions. • Manage and/or operationalize the delivery of day-today regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies. • Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle. • Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems. • Prepare estimates for conducting regulatory services as part of single or multiple service proposals. • Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities. • Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes. • Prepare training materials and share best practices in the regulatory area, both internally and externally. • Participate as regulatory support in internal or external project audits. • Participate as regulatory support on internal cross-functional initiatives. • Contribute to the creation and/or maintenance of SOPs and other process related documentation as required. • Provide support in oversight to team members in the execution of their project responsibilities. • Capable of identifying when to ensure line support required to provide additional guidance and direction. • Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training. At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range $56,400.00 - $95,900.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary • Previous CMC experience is required. *Open to all of North America, but must agree to work EST zone.