Syneos Health

Leading scientific strategy and initiatives across R&D functions, engaging with senior stakeholders, and representing the company in industry forums. | Extensive clinical development leadership experience, knowledge of FDA regulations, and proven ability to lead matrix teams in a biopharma setting. | Head of R&D and Scientific Strategy, Rare Disease 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 Under the guidance and direction of the Chief Scientific Officer (CSO), the Head of R&D and Scientific Strategy is responsible for supporting or leading matrix teams or enterprise-wide initiatives aimed at driving value by harnessing the Company’s scientific capabilities. The office of the CSO is focused on pulling together medical and scientific capabilities across the Company’s different functions and business units to create innovative solutions for our customers and to drive collaboration across the enterprise. Examples of such teams/initiatives include the Cross Functional Constortia, Lab to Life delivery, and Cross BU solutions development, and our Biotechnology Customer Solutions Platform. The office of the CSO also drives and supports our Scientific communications and Thought Leadership Strategy. The Head of R&D and Scientific Strategy will have responsibilities for contributing to and executing on this strategy in conjunction with the internal. medical and scientific community. The Head of R&D and Scientific Strategy will have customer facing responsibilities that may include customer meetings to understand potential work models, bid defenses, or meetings aimed at increasing awareness and growth of our scientific reputation. The Head of R&D and Scientific Strategy may engage C-level personnel to ensure the Company maintains complementary development pipelines with the potential to become long term and meaningful relationships for the Company. The Head of R&D and Scientific Strategy will interact with senior management, customers, business development, and project teams to coordinate services and provides direction and strategy for growth and provides consulting, as needed. Integrates the Company’s resources (from all areas) to craft tailored scientific solutions for the targeted internal issues or customer problems. Consults with appropriate internal and external stakeholders regarding the respective area’s clinical and commercial issues and points of interest. •Acts as a primary senior-level contact for initiatives/teams the Head of R&D and Scientific Strategy is leading. •Participates in customer proposals, Request for Information (RFIs), presentations, proposal defenses and Steering Committees. •Responsible for coordinating the acquisition of necessary medical/scientific input from outside experts/consultants/advisors. •Represents the Company and the CSO office by attending industry meetings, speaking engagements, participating in booth exhibitions, etc., and by publishing scientific or industry related articles in industry journals. •Ensures quality standards are set and maintained over all areas of responsibility. •Line management responsibilities include professional development and performance management of subordinate staff. Delegates to and reviews progress and performance of all direct reports. •Other tasks and duties as determined appropriate by Executive Management. MD, DO preferred. •Extensive clinical development leadership experience in biopharma, CRO, or consulting. Experience working inside a Pharma preferred. •Extensive leadership experience in a clinical research organization, including clinical operations, business development and management and/or senior management experience. •Academic or industry experience in clinical medicine or drug development. •Some experience in actively managing clinical research projects across functional areas preferred. •Thorough knowledge of FDA regulations, drug development, and clinical monitoring procedures is necessary. •Must have demonstrated proficiency with ICH/GCP guidelines. •Excellent time management skills to handle multiple tasks and meet deadlines delivering high quality work in a dynamic environment is essential. •Requires excellent presentation, documentation and interpersonal skills as well as a team-oriented approach. •Experience working in a matrixed team environment is critical. Requires strong skills in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. •Superior presentation, documentation, negotiation, leadership and interpersonal skills with a strong team-oriented approach. •Ability to perform several tasks simultaneously to meet deadlines is necessary. 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 complex Phase III oncology/hematology clinical trials, ensuring timely delivery, budget management, and stakeholder communication. | Extensive experience in managing Phase III clinical trials in oncology/hematology, with strong leadership, regulatory, and cross-functional team skills. | Senior Clinical Project Manager – Oncology/Hematology (Phase III) Required (Remote - US/Canada) 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 Senior Project Manager – Oncology/Hematology (Phase III) Are you a seasoned CRO project leader passionate about advancing oncology and hematology research? Do you thrive in a fast-paced, collaborative environment where your leadership directly impacts patient outcomes? Join our team as a Senior Project Manager and take ownership of complex Phase III trials, driving projects from proposal through delivery and shaping the future of cancer care. About the Role: As a Senior Project Manager, you will take a lead role in advancing Phase III Oncology and Hematology clinical trials, managing complex, global initiatives. You’ll lead and inspire cross-functional teams, mentor emerging project managers, and act as the primary strategic partner for our clients, ensuring every milestone is delivered on time, on budget, and with exceptional quality. This role offers the opportunity to drive high-impact research that directly contributes to innovative cancer therapies and improved patient outcomes worldwide. What You’ll Do: Project Leadership & Delivery Drive the operational and financial success of Phase III clinical trials. Lead cross-functional teams across Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Medical Affairs, Pharmacovigilance, and QA. Act as the primary liaison with clients, ensuring smooth project launch, conduct, and closeout. Oversee project deliverables, timelines, and budgets while proactively identifying and mitigating risks. Mentor junior project managers and project support staff, fostering collaboration and professional growth. Financial & Operational Accountability Own project budgets, forecasts, and financial performance. Ensure alignment and accountability across all vendors and study partners. Implement contingency plans and risk mitigation strategies to keep projects on track. Reporting & Communication Maintain and evaluate project progress using advanced tracking tools. Prepare and present project materials for internal and external stakeholders. Support inspection readiness and Trial Master File compliance. Business Development Participate in bid defense meetings as the potential project lead. Build strong client relationships to generate new opportunities. Stay up-to-date on oncology/hematology trends and the evolving drug development landscape. Management & Mentorship Train and mentor new project managers and clinical staff. Facilitate team communication, collaboration, and professional development. Who You Are: Experienced Global Project Leader (NA, LATAM, EMEA, and APAC) with strong Phase III CRO project management experience and a proven track record of delivering clinical trials successfully. Oncology and Hematology expertise, with direct experience leading complex Phase III trials. Cross-functional team leadership, overseeing such teams as Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Medical Affairs, Pharmacovigilance, and Quality Assurance. Financially savvy, skilled in managing multi-million-dollar budgets, including creation, forecasting, and negotiation of out-of-scope work. Vendor management expertise, ensuring alignment, quality, and accountability across all study partners. Deep regulatory knowledge, with expertise in GCP/ICH guidelines and other applicable regulatory requirements. Educational foundation: Bachelor’s degree in Life Sciences, Medicine, Pharmacy, Nursing, or a related field. Tech-forward, comfortable leveraging digital tools and emerging technologies to optimize project delivery. Strategic, results-driven leader with exceptional communication skills, able to navigate complex, dynamic environments while inspiring teams to achieve excellence. Why You’ll Love Working Here: Join a highly collaborative, innovative, and performance-driven team. Opportunities to mentor and be mentored, helping you grow professionally while developing others. Work on impactful global oncology and hematology trials, shaping the future of patient care. Thrive in an environment where innovation, growth, and professional development are actively encouraged. If you are ready to lead high-impact Phase III oncology and hematology clinical trials, drive innovation, and make a real difference in patient outcomes, we want to hear from you! 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 complex Phase III oncology/hematology clinical trials, ensuring successful delivery and client satisfaction. | Experience leading global Phase III clinical trials in oncology/hematology, strong project management skills, and regulatory knowledge. | Senior Project Manager - Oncology/Hematology (Phase III) 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 Senior Project Manager - Oncology/Hematology (Phase III) Are you a seasoned CRO project leader passionate about advancing oncology and hematology research? Do you thrive in a fast-paced, collaborative environment where your leadership directly impacts patient outcomes? Join our team as a Senior Project Manager and take ownership of complex Phase III trials, driving projects from proposal through delivery and shaping the future of cancer care. About the Role: As a Senior Project Manager, you will take a lead role in advancing Phase III Oncology and Hematology clinical trials, managing complex, global initiatives. You'll lead and inspire cross-functional teams, mentor emerging project managers, and act as the primary strategic partner for our clients, ensuring every milestone is delivered on time, on budget, and with exceptional quality. This role offers the opportunity to drive high-impact research that directly contributes to innovative cancer therapies and improved patient outcomes worldwide. What You'll Do: Project Leadership & Delivery • Drive the operational and financial success of Phase III clinical trials. • Lead cross-functional teams across Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Medical Affairs, Pharmacovigilance, and QA. • Act as the primary liaison with clients, ensuring smooth project launch, conduct, and closeout. • Oversee project deliverables, timelines, and budgets while proactively identifying and mitigating risks. • Mentor junior project managers and project support staff, fostering collaboration and professional growth. Financial & Operational Accountability • Own project budgets, forecasts, and financial performance. • Ensure alignment and accountability across all vendors and study partners. • Implement contingency plans and risk mitigation strategies to keep projects on track. Reporting & Communication • Maintain and evaluate project progress using advanced tracking tools. • Prepare and present project materials for internal and external stakeholders. • Support inspection readiness and Trial Master File compliance. Business Development • Participate in bid defense meetings as the potential project lead. • Build strong client relationships to generate new opportunities. • Stay up-to-date on oncology/hematology trends and the evolving drug development landscape. Management & Mentorship • Train and mentor new project managers and clinical staff. • Facilitate team communication, collaboration, and professional development. Who You Are: • Experienced Global Project Leader (NA, LATAM, EMEA, and APAC) with strong Phase III CRO project management experience and a proven track record of delivering clinical trials successfully. • Oncology and Hematology expertise, with direct experience leading complex Phase III trials. • Cross-functional team leadership, overseeing such teams as Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Medical Affairs, Pharmacovigilance, and Quality Assurance. • Financially savvy, skilled in managing multi-million-dollar budgets, including creation, forecasting, and negotiation of out-of-scope work. • Vendor management expertise, ensuring alignment, quality, and accountability across all study partners. • Deep regulatory knowledge, with expertise in GCP/ICH guidelines and other applicable regulatory requirements. • Educational foundation: Bachelor's degree in Life Sciences, Medicine, Pharmacy, Nursing, or a related field. • Tech-forward, comfortable leveraging digital tools and emerging technologies to optimize project delivery. • Strategic, results-driven leader with exceptional communication skills, able to navigate complex, dynamic environments while inspiring teams to achieve excellence. Why You'll Love Working Here: • Join a highly collaborative, innovative, and performance-driven team. • Opportunities to mentor and be mentored, helping you grow professionally while developing others. • Work on impactful global oncology and hematology trials, shaping the future of patient care. • Thrive in an environment where innovation, growth, and professional development are actively encouraged. If you are ready to lead high-impact Phase III oncology and hematology clinical trials, drive innovation, and make a real difference in patient outcomes, we want to hear from you! 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.

Lead and perform copy editing and quality control for regulatory medical documents, ensuring compliance with industry standards and guidelines. | Requires extensive experience in medical editing within a regulatory environment, familiarity with FDA and EU guidelines, and project leadership skills. | Senior Medical Editor - Copy Editing + QC - Regulatory (EMEA Home 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 •Maintains strong 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 quality review, compilation, and editorial standards. Provides training to members of the global medical writing team in aspects relative to their roles. •Serves as 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 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 editorial process. •Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following AMA Manual of Style or various custom style guidelines as well as established medical writing internal checklists and best practices. •Performs quality 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 medical writing deliverables. 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 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.