Parexel

Manage and lead clinical trial study operations including startup, site activation, recruitment, and vendor oversight. | Bachelor's degree with 5+ years clinical trial operational experience or advanced degree with 3+ years; scientific or technical degree preferred. | When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Study Operations Manager I (SOM I) has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on one or more studies, providing leadership, strategic planning, and organization skills to ensure the operational delivery of tasks. • Serves as leader of the local study team on one or more studies • Provides back up to or assumes the responsibilities of the GSM as needed • Oversees the preferred Contract Research Organization and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans) • May manage the study start up process in countries assigned and/or oversee the CRO responsible for these activities as applicable • Liaises with SCP, Lead SCP, Site Activation Partners and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethics Committees (ECs) • Provides country level input on startup and recruitment milestones during planning • Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. • Accountable for resolution of site activation escalations to study teams including offering options for mitigation • Fully responsible and accountable for, as designated by the GSM: • Regional, country, and study level implementation of startup and site activation plans • Regional, country and study level recruitment strategy • Development of study level plans • Communication with the local team and internal stakeholders and CRO as applicable to ensure efficient and timely study delivery of the agreed plans • Study and/or country vendor management and oversight including follow up and coordination of vendor deliverables • Assurance of the follow up and coordination of regional and site quality events, protocol deviations, data issues, metrics review, site issues and risks, audit responses, etc. Requirements: • Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 5 years of relevant operational clinical trial experience required • Master’s of Science or Master’s of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required • A scientific or technical degree is preferred #LI-LO1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Provide medical leadership and oversight for clinical trials, including study planning, data review, and safety monitoring, while supporting business development and client relationships. | Requires medical qualification, clinical medicine experience, and knowledge of drug development, with leadership skills in a CRO or pharmaceutical environment. | When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Senior Medical Director is a recognized medical expert and leader with both specialized therapeutic expertise and broad experience across indications, clients and drug development. They initiate and maintain medical and consultative relationships with clients, consult on early engagement and pre-award efforts and serve as a medical monitor for contracted projects. The Senior Medical Director may represent GMS on cross-functional initiatives, lead initiatives within GMS, and where appropriate, manage a small team of physicians. Key Accountabilities: Project Execution: Medical Monitoring Delivery & PV Support: Independently deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor (i.e.: tasks and time per task contracted) and according to the assigned role (Global Lead Physician or Regional Lead Physician). Participate actively in study planning with feasibility leaders, solution consultants Participate in team project and investigator meetings Provide training of study teams on TA indication and protocol (Note that this does not include any direct medical advice on patient care or management) Communicate with relevant sponsor counterparts on challenges and accomplishments related to assigned project/study Participate in the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), integrated clinical and statistical summary reports, safety plans, Informed Consent Forms, etc. in conjunction with clients/sponsors or in conjunction with other Parexel departments Deliver medical monitoring activities according to MMP during the study conduct: Answer to site/ study team questions relating to the study conduct or protocol, Review and sign off all data listings / tables, protocol deviations, datasets, for medical accuracy/consistency in accordance with study plans (Medical Monitoring Plan, Medical Data Review Plan, Data Surveillance Plan etc.) Deliver medical leadership to the project in close coordination with the Project Leader and according to the role assigned either GLP or RLP by Timely identifying risks and challenges, Pro-actively proposing and/or delivering relevant actions contributing to the success of the study/project and risk mitigation. Creating a sense of urgency on any matters pertaining to safety of study participants and scientific integrity of the study. Attend and support any audits or inspections pertaining to assigned studies even if not directly involved in the audited activities Participate in periodic rotas including night and weekend shifts e.g. for emergency medical contact and emergency unblinding phone requests for Parexel studies, as applicable and/or appropriate for the MD Provide risk assessment of clinical trials for local sponsorship as needed Provide medical input into PV workflows and projects and participate in safety processing for studies including medical review of serious adverse events. Support regulatory safety reporting activities Utilize metrics and key performance indicators to ensure high quality, cost effective delivery of medical services Client Relationship Building & Engagement: Actively listen to, solicit and address client feedback and suggestions regarding medical study-related activities in order to enhance client satisfaction Follow up satisfaction metrics pertaining to medical activities in assigned studies and propose / execute remediation plan in coordination with line manager and Project Leader in case of client dissatisfaction. Integrate and put client interest and need first to build trust and demonstrate credibility, reliability, intimacy, and confidence Be a point of escalation for issues and arrange for resolution by effective interaction and negotiation with appropriate departments and senior leadership. Drive continuous improvements in meeting client expectations. Business Development: Autonomously support Business Development as a core priority while adequately balancing time devoted to this activity with billable tasks. In line with business development objectives, meet and attend phone conferences with clients to communicate and detail Parexel medical expertise and experience in a therapeutic area or in an indication. Provide medical expertise / leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings Attend preparation meeting and Bid pursuit meetings as required Provide support for marketing activities as requested. Share sponsor insights and experiences (strategy, history, culture, priorities etc.) with peer and proposal teams With the Section Head, develop a vision and make recommendations within own area of expertise to develop the size of Parexel activities in this area Coach and mentor junior team members on effective collaboration with clients as appropriate Medical Expertise: Work with Section Head to develop expertise in therapeutic area, including training of internal colleagues Provide senior/advanced medical expertise across multiple channels and interactions such as: Consultancy on protocol development or drug development program Medical review of various documents, which might be audited by clients and regulatory agencies Write clear, concise medical documents including complex and strategic matters Initiate and participate in activities to raise, coordinate and promote Parexel medical expertise both internally and externally including but not limited to internal therapeutic area meetings, training modules development, white papers, slide sets, publications etc. Support patient centricity, diversity and inclusion in all projects Departmental and Team Leadership, where applicable: Participate as requested in internal initiatives aiming at improving Parexel and GMS operational model Contribute to the development of departmental capabilities including procedures and technology Actively work with Section Heads to ensure development and performance of self and team Create a culture of continuous improvement and lead team through change to deliver desired outcomes Support timely assignment of MD to proposals, projects and studies Manage the team members according to Parexel tools, guidelines and procedures Guide, energize, motivate and coach team members to perform at the top of their abilities, in line with Parexel values and their organizational and personal career goals Support talent development of team and create environment and opportunities for each team member to thrive Mentor/Manage team through clear and specific definition of accountabilities and expectations, assigning task/projects based on competencies and skills and helping staff to prioritize workload: to maintain adequate billability rate and efficient ratio between workload and personal life according to local guidelines to provide efficient support to BD activities including request for proposals, participation in bid pursuit meetings, capability meetings etc. Recognize and reward colleague achievements Skills: Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts, internal colleagues and to manage and mentor staff Client-focused approach to work Excellent verbal and written medical and business communication skills Excellent standard of written and spoken English Excellent problem solving, risk assessment and decision-making skills at the department and enterprise level with the ability to analyze business needs and act decisively A flexible attitude with respect to work assignments and new learning Excellent time management skills Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Willingness to work in a matrix environment and to value the importance of teamwork Knowledge and Experience: Experience in clinical medicine (general or specialist qualifications) with a specialty in women's health (OB/GYN), which is expected to be kept up to date A strong background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution within a pharmaceutical, biotech or CRO environment Excellent knowledge of the drug development process including drug safety Clinical practice experience Understanding of the business model of a CRO Level of expertise is recognized internally and by others in the industry Experience in Pharmaceutical Medicine, preferred Education: Medically qualified in an acknowledged medical school with completion of at least a basic training in clinical medicine (residency, internship) EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Leading healthcare data platform architecture, analytics, and cloud transformation initiatives. | Extensive experience in healthcare data systems, cloud architecture, and leadership, with no specific clinical or medical expertise in women's health or drug development. | The Senior Medical Director is a recognized medical expert and leader with both specialized therapeutic expertise and broad experience across indications, clients and drug development. They initiate and maintain medical and consultative relationships with clients, consult on early engagement and pre-award efforts and serve as a medical monitor for contracted projects. The Senior Medical Director may represent GMS on cross-functional initiatives, lead initiatives within GMS, and where appropriate, manage a small team of physicians. Key Accountabilities: Project Execution: Medical Monitoring Delivery & PV Support: • Independently deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor (i.e.: tasks and time per task contracted) and according to the assigned role (Global Lead Physician or Regional Lead Physician). • Participate actively in study planning with feasibility leaders, solution consultants • Participate in team project and investigator meetings • Provide training of study teams on TA indication and protocol (Note that this does not include any direct medical advice on patient care or management) • Communicate with relevant sponsor counterparts on challenges and accomplishments related to assigned project/study • Participate in the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), integrated clinical and statistical summary reports, safety plans, Informed Consent Forms, etc. in conjunction with clients/sponsors or in conjunction with other Parexel departments • Deliver medical monitoring activities according to MMP during the study conduct: • Answer to site/ study team questions relating to the study conduct or protocol, • Review and sign off all data listings / tables, protocol deviations, datasets, for medical accuracy/consistency in accordance with study plans (Medical Monitoring Plan, Medical Data Review Plan, Data Surveillance Plan etc.) • Deliver medical leadership to the project in close coordination with the Project Leader and according to the role assigned either GLP or RLP by • Timely identifying risks and challenges, • Pro-actively proposing and/or delivering relevant actions contributing to the success of the study/project and risk mitigation. • Creating a sense of urgency on any matters pertaining to safety of study participants and scientific integrity of the study. • Attend and support any audits or inspections pertaining to assigned studies even if not directly involved in the audited activities • Participate in periodic rotas including night and weekend shifts e.g. for emergency medical contact and emergency unblinding phone requests for Parexel studies, as applicable and/or appropriate for the MD • Provide risk assessment of clinical trials for local sponsorship as needed • Provide medical input into PV workflows and projects and participate in safety processing for studies including medical review of serious adverse events. • Support regulatory safety reporting activities • Utilize metrics and key performance indicators to ensure high quality, cost effective delivery of medical services Client Relationship Building & Engagement: • Actively listen to, solicit and address client feedback and suggestions regarding medical study-related activities in order to enhance client satisfaction • Follow up satisfaction metrics pertaining to medical activities in assigned studies and propose / execute remediation plan in coordination with line manager and Project Leader in case of client dissatisfaction. • Integrate and put client interest and need first to build trust and demonstrate credibility, reliability, intimacy, and confidence • Be a point of escalation for issues and arrange for resolution by effective interaction and negotiation with appropriate departments and senior leadership. • Drive continuous improvements in meeting client expectations. Business Development: • Autonomously support Business Development as a core priority while adequately balancing time devoted to this activity with billable tasks. • In line with business development objectives, meet and attend phone conferences with clients to communicate and detail Parexel medical expertise and experience in a therapeutic area or in an indication. • Provide medical expertise / leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings • Attend preparation meeting and Bid pursuit meetings as required • Provide support for marketing activities as requested. • Share sponsor insights and experiences (strategy, history, culture, priorities etc.) with peer and proposal teams • With the Section Head, develop a vision and make recommendations within own area of expertise to develop the size of Parexel activities in this area • Coach and mentor junior team members on effective collaboration with clients as appropriate Medical Expertise: • Work with Section Head to develop expertise in therapeutic area, including training of internal colleagues • Provide senior/advanced medical expertise across multiple channels and interactions such as: • Consultancy on protocol development or drug development program • Medical review of various documents, which might be audited by clients and regulatory agencies • Write clear, concise medical documents including complex and strategic matters • Initiate and participate in activities to raise, coordinate and promote Parexel medical expertise both internally and externally including but not limited to internal therapeutic area meetings, training modules development, white papers, slide sets, publications etc. • Support patient centricity, diversity and inclusion in all projects Departmental and Team Leadership, where applicable: • Participate as requested in internal initiatives aiming at improving Parexel and GMS operational model • Contribute to the development of departmental capabilities including procedures and technology • Actively work with Section Heads to ensure development and performance of self and team • Create a culture of continuous improvement and lead team through change to deliver desired outcomes • Support timely assignment of MD to proposals, projects and studies • Manage the team members according to Parexel tools, guidelines and procedures • Guide, energize, motivate and coach team members to perform at the top of their abilities, in line with Parexel values and their organizational and personal career goals • Support talent development of team and create environment and opportunities for each team member to thrive • Mentor/Manage team through clear and specific definition of accountabilities and expectations, assigning task/projects based on competencies and skills and helping staff to prioritize workload: • to maintain adequate billability rate and efficient ratio between workload and personal life according to local guidelines • to provide efficient support to BD activities including request for proposals, participation in bid pursuit meetings, capability meetings etc. Recognize and reward colleague achievements Skills: • Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts, internal colleagues and to manage and mentor staff • Client-focused approach to work • Excellent verbal and written medical and business communication skills • Excellent standard of written and spoken English • Excellent problem solving, risk assessment and decision-making skills at the department and enterprise level with the ability to analyze business needs and act decisively • A flexible attitude with respect to work assignments and new learning • Excellent time management skills • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail • Willingness to work in a matrix environment and to value the importance of teamwork Knowledge and Experience: • Experience in clinical medicine (general or specialist qualifications) with a specialty in women's health (OB/GYN), which is expected to be kept up to date • A strong background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution within a pharmaceutical, biotech or CRO environment • Excellent knowledge of the drug development process including drug safety • Clinical practice experience • Understanding of the business model of a CRO • Level of expertise is recognized internally and by others in the industry • Experience in Pharmaceutical Medicine, preferred Education: • Medically qualified in an acknowledged medical school with completion of at least a basic training in clinical medicine (residency, internship) #LI-REMOTE

Support regulatory strategy, prepare and review CMC documentation, and collaborate across functions to ensure compliance and efficiency in pharmaceutical product development. | Requires 4-6+ years of pharmaceutical CMC regulatory experience, with expertise in FDA, EMA, and Health Canada submissions, GMP, and drug development processes. | When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. In this role, you will help ensure our clients’ investigational, new, and marketed small‑molecule and biologic products are developed and maintained in full alignment with global regulatory requirements. Your primary geographic focus will include the United States, European Union, and Canada, with an emphasis on enabling timely approvals and supporting sustained market access. You will contribute to both operational execution and strategic regulatory planning, working across a diverse portfolio of programs. The ideal candidate thrives in a collaborative environment and brings a balanced blend of hands‑on authoring expertise and forward‑looking regulatory insight. Key Responsibilities Strategic CMC Leadership • Provide regulatory strategy input for small molecule and biologic products • Support regulatory leads in developing contingency plans for CMC-related scenarios • Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads Submission & Documentation Excellence • Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions • Develop CMC strategies for products across all phases—from early development to marketing applications and post-approval changes Cross-Functional Collaboration • Partner with manufacturing, quality, and external organizations to address CMC-related issues • Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers • Support planning and execution of Health Authority meetings, including mock sessions Process Optimization & Innovation • Identify and implement process improvements to enhance regulatory efficiency and readiness • Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions • Utilize regulatory systems and tools including CREDO, Trackwise Digital, and TRS Viewer Regulatory Systems & Reporting • Experience with CPP application filing via eCATS and 510(j)(3) reporting through nextGen portals is a plus • Ensure audit readiness and version control through meticulous documentation and system management Qualifications Experience & Expertise • 4–6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant • Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF) • In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules and biologics. Previous experience with combination device products is a plus! Skills & Attributes • Strategic and proactive mindset with strong operational execution • Excellent analytical, problem-solving, and negotiation skills • Effective communicator with strong interpersonal, presentation, and leadership abilities • Ability to manage multiple projects independently in a matrixed, multicultural environment • Proficiency in Microsoft Office Suite and regulatory systems Education • Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or related field • Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred • RAC certification is a plus Given the client's location, preference will be given to candidates residing in the Eastern Time Zone. However, exceptional individuals based other Time Zones will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed. #LI-LB1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Configure and support structured content authoring platforms for regulatory documentation workflows, ensuring compliance and user support. | Experience with structured content platforms, medical writing, regulatory documentation, and GxP compliance, with a scientific background and strong collaboration skills. | When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Company: Parexel is hiring an FSP - Senior Medical Writer with Structured Content Authoring experience to work Remotely. Location: Remote (anywhere in US or Canada) Employment Type: Full-time About Parexel At Parexel, we are dedicated to improving patient lives through innovative clinical research and regulatory solutions. As a leading global clinical research organization (CRO), we partner with the world’s most prominent biopharmaceutical companies to bring life-changing therapies to market. Our culture is built on collaboration, integrity, and a shared commitment to excellence—where your expertise can make a real impact on global health. Role Summary Parexel is seeking an experienced Senior Medical Writer, Structured Content Authoring to support the Structured Content Authoring (SCA) initiative. This position focuses exclusively on SCA and involves configuring the platform for medical writing and regulatory documentation workflows. The role combines technical configuration expertise with a strong understanding of structured content authoring and regulatory standards. The ideal candidate will ensure seamless configuration, integration, and optimization of SCA to meet project and compliance requirements. This position also offers the opportunity to provide end-user support as the user base grows—making it a great learning experience and a chance to deliver impactful solutions. Key Responsibilities Configure and maintain SCA platform settings to support medical writing and regulatory workflows. Customize templates, metadata fields, and document structures for compliance and efficiency. Implement and validate workflow configurations for review, approval, and version control. Ensure integration of SCA with other enterprise systems (e.g., PleaseReview, Veeva RIM). Conduct functional testing and troubleshoot configuration issues. Maintain detailed documentation of configuration changes for audit readiness. Collaborate with internal teams to gather requirements and translate them into technical solutions. Provide user training and support on SCA features and best practices. Offer end-user support (as availability allows) to assist with onboarding and troubleshooting, helping new users adapt to the platform. Ensure all configurations comply with regulatory standards and company SOPs. Required Qualifications Proven experience with SCA platforms. Background in medical writing or strong familiarity with regulatory documentation processes. Hands-on experience in content creation, review, standardization, and management within a structured content platform. Demonstrated ability to collaborate with cross-functional teams to support regulatory consistency and harmonization of content across multiple documents. Familiarity with core content reuse strategies, metadata management, and troubleshooting within the platform. Strong problem-solving skills and attention to detail. Familiarity with compliance and audit requirements in a GxP environment. Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar. Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. Preferred Qualifications Experience training users or driving adoption of structured content methods. Hands-on experience with automation of regulatory medical writing documents and (SCA) Structured Content Authoring platforms. Experience working in a CRO or pharmaceutical environment. Knowledge of electronic submission standards (e.g., eCTD). Strong communication skills for cross-functional collaboration. Ability to work independently and manage multiple priorities. Education Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. Why Join Parexel? Impactful Work: Contribute to projects that accelerate the delivery of life-saving therapies to patients worldwide. Global Collaboration: Work with diverse teams across the globe in a dynamic, innovative environment. Career Growth: Access to professional development programs, mentorship, and opportunities for advancement. Flexibility: Enjoy the benefits of a fully remote role with a healthy work-life balance. Inclusive Culture: Be part of a company that values diversity, integrity, and collaboration. Apply today and join Parexel in shaping the future of clinical research. #LI-CF1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Lead and develop global labeling strategies and collaborate with regulatory teams to ensure compliance and alignment with product development. | Requires 6-8 years of pharmaceutical labeling/regulatory experience, with knowledge of CCDS and local labeling documents, and strong project management skills. | When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Exciting temporary labeling strategist role dedicated to one large client partnership! The Labeling Strategist will drive the labeling development and strategy, in-line with overall global strategy, and by providing labeling expertise for Company Core Data Sheet (CCDS) and local labeling (USPI, SmPC and other), from early-stage development through to product maintenance. Facilitates strategic development of labeling and labeling components by leading a diverse cross-functional labeling subteam through discussion and decisions. Evaluates and communicates strategies and anticipates risks associated with labeling content, timelines, labeling compliance and implementation. Responsibilities Demonstrate high-level understanding of labeling content requirements, regulations, and guidance in support of labeling strategies worldwide, including key scientific, clinical, medical, and key messages and differentiation strategies. Leads or contributes to cross functional teams across the organization, to drive and align the development and maintenance of global labeling (e.g. CCDS, regional product labels, and patient labeling) for assigned compounds. Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product global strategy and key messaging. Evaluate and communicate risks associated with CCDS content updates and implementation strategies. Drive labeling for package labeling (mockups/artwork) development, update, and maintenance through collaboration with a cross-functional team. Support global HA interaction strategy regarding all aspects of labeling, including submissions, responses to questions, and negotiations. Demonstrate understanding of current labeling content requirements, regulations, and guidance to ensure all assigned compound labeling documents are accurate, consistent, and compliant. Assess competitor labeling in the same therapeutic class, competitor labeling and labeling trends, proposing content as relevant to support optimized labeling Manage and maintain labeling documents in document management systems; Manage label review and approval. Author, contribute, and/or review labeling sections of various periodic reports (i.e., Annual Report, PSUR, PADER, etc.). Support inspection readiness activities related to all global labeling components. Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. Collaborate with global colleagues, affiliates and Alliance partners, as needed. Develop clear communications for senior management and labeling stakeholders, to streamline and facilitate label development, negotiations, and approval. During HA reviews, continuously assess dossier review comments for potential labeling impact, development of alternate proposals, and negotiation strategies. Support global HA interaction strategy to discuss key labeling elements Lead response to Health Authority (HA) questions for labeling. Respond to labeling related inquiries from global Health Authorities in an efficient manner to meet required timelines. Analyze and interpret new regulations and Guidance, as well as monitor and determine impact on product labeling. Qualifications Education and Experience BSc or advanced scientific degree (MSc, PhD or PharmD) preferred. 6-8 years of relevant pharmaceutical Labeling/Regulatory experience. Thorough understanding of scientific principals and regulatory systems, relevant to drug development Experience writing CCDS and local labeling documents for new products Knowledge and Skills Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required Solid understanding of implications of global labeling across the organization and globally Solid understanding of the structure of product labeling Experience in effectively/appropriately prioritizing and managing multiple high to medium complex projects simultaneously Ability to work independently or in teams, globally. Ability to lead broad range of stakeholders at all levels internally and externally to the company. Effective written and oral communication and organizational skills Strong attention to detail Solid aptitude for use of IT systems; preferable knowledge with Regulatory Information Management System (RIMS) and electronic document management system (EDMS); Proficiency in MS Office suite; Willing to learn additional applications Ability to think strategically, communicate risks, and recommend innovative solutions to problem solving Ability to recognize and escalate issues The ideal candidate should be action-oriented, customer focused, ability to manage workloads and set priorities. In addition, he/she should be capable of dealing with ambiguity, be creative, and be comfortable working with multifunctional teams. Candidates located within the EST in the US or Canada are highly preferred due to the client's locations. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Oversee and lead the Patient Safety Project Leadership function, driving strategy, operational excellence, and client engagement. | Requires 13+ years in pharma or CRO, with 7-10 years in management, and knowledge of drug safety and pharmacovigilance, which are not reflected in your experience. | As Executive Director, Patient Safety you will oversee the management and leadership of Parexel's Patient Safety pillar, team or functions within Patient Safety organization. In this case, the Patient Safety Project Leadership Organization. The Executive Director will work with senior management, customers, business development, and project teams providing oversight of processes and functions related to the delivery of a program or portfolio of Patient Safety Services. You will lead operational level planning with significant business oversight, drive ‘positive change’ throughout Parexel through continuous process improvement programs, as well as make significant contributions to the leadership of the Business Unit (BU) and the development of the strategy and direction of the BU. The Executive Director will lead the operational contribution to proposal development and business development activities at a project level. Key Accountabilities: Leadership • Leads a business function (Patient Safety Project Leadership) within the Patient Safety organization. Is accountable for setting the business function strategy and delivery against that strategy. • Provides leadership and guidance across initiatives, facilitates discussions, and contributes to strategic planning to enable and support optimal end-to-end delivery of Patient Safety projects under their remit. • Supports the achievement of Patient Safety organization financial targets. Responsible for the strategic planning of Safety Project Leadership to enhance the financial and operational performance of the wider department including plans for expanding departmental revenue, margin, and resources. Develops and implements appropriate cost reduction solutions within span to improve profitability. • Demonstrates a deep understanding of the current business offerings and stays current on all aspects of business intelligence. Continually challenges the status quo and encourages incremental improvements in strategy and efficiency of the Patient Safety organization. • Demonstrates leadership within the Patient Safety organization and wider Company, including maintaining an active external brand and thought leadership status. Team Management • Provides senior operational and strategic direction for Safety Project Leadership. • Mentor, support and direct functional team within span to develop robust patient engagement strategies and deliver programs to client specifications. • Identify knowledge gaps and develop and implement plans to build skills for self, team and operational teams across the business. • Holds team and individuals accountable for achieving financial and operational targets and corporate business goals including closure of quality issues. • Oversight of employees including goal setting and measurement, approval of timesheets, and performance reviews. Metrics Management • Facilitates functional team metrics collection and case study creation to support the Patient Safety organization including monthly KPI metrics. • Identifies and proposes strategies, procedures, systems, technology, or efficiencies to improve productivity of own span and Patient Safety team. Client Management & New Business Generation • Provides support to the Parexel business operations teams in the development of proposals and the bid defense process. • Acts as an elevated point of contact for strategic partnerships and key clients. Technical • Directs, leads and provides guidance to the teams in all aspects of Safety Project Leadership • Provide expertise in Safety Project Leadership and project management best practices Quality and Compliance • Strive to ensure internal and external clients receive the required deliverables within stipulated timelines and budget • Ensure projects assigned to line reports are completed with quality, according to SOPs, and regulatory guidelines Skills: • Excellent leadership and line management skills • Excellent knowledge of drug safety and the drug development process • Excellent knowledge of and ability to interpret and apply global safety regulations • Experience in data analysis, evaluation of safety data and the preparation of safety reports preferred • Excellent team / project leadership and delegation skills • Ability to train and mentor people • Excellent presentation skills • Excellent interpersonal skills • Excellent time management skills • Client focused approach to work • Experience with Pharmacovigilance related computing systems • Clinical Research or Pharmacovigilance knowledge /qualifications • Computer proficiency, ability to work with web-based applications and familiarity with the Windows operating system and Microsoft Office apps • Ability to comprehend various regulatory or client requests and be able to strategize a handling approach • Flexible attitude with respect to work assignments and new learnings • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail • Willingness to work in a matrix environment and to value the importance of teamwork Knowledge and Experience: • Minimum 13+ years of pharmaceutical and/or CRO experience including but not limited to areas of focus in clinical operations, sales and decentralized clinical trials/direct to patient studies • 7-10 years of management experience, including direct project management or program oversight Education: • Requires BA/BS degree or equivalent combination of education and experience or equivalent related degree and/or experience, plus significant executive and/or senior management experience, preferably in worldwide clinical research, pharmaceutical, or biotechnology company. A strong background in Safety Operations execution is desirable. Minimum of thirteen (13) years of related experience, including seven to ten (7-10) years of progressive management experience, including direct project management or program oversight. #LI-REMOTE

Lead regulatory CMC strategy for peptide and oligonucleotide therapeutics, ensuring compliance and facilitating product approvals. | Requires 4-7 years in peptide or oligonucleotide synthesis, regulatory expertise, and proficiency with analytical instruments, which do not align with your healthcare administration background. | When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Exceptional opportunity for a highly experienced analytical chemist to partner with a large global biopharmaceutical client and lead regulatory CMC strategy for cutting‑edge peptide and oligonucleotide therapeutics. In this role, the Regulatory Affairs Senior/Consultant will drive global regulatory strategy and submission activities for complex synthetic and nucleic acid–based products, partnering closely with R&D, CMC, clinical, and quality teams to ensure compliance with international standards and accelerate successful product approvals. Qualifications & Experience Educational Background Bachelor’s or Master’s degree in chemistry, biochemistry, pharmaceutical sciences, or related discipline. Ph.D. in organic chemistry is preferred if possible. Technical & Regulatory Expertise 4-7 years in peptide or oligonucleotide synthesis, purification, and analytical testing (HPLC, LC-MS, NMR). Hands-on experience with solid-phase synthesis or phosphoramidite-based workflows. Familiarity with purity, identity, sequence confirmation, and impurity profiling requirements per FDA/ICH/USP standards. Regulatory & Professional Competencies Strong understanding of regulatory requirements for synthetic peptides and oligonucleotides and ability to analyze guidelines and precedents. Proven track record preparing CMC documents and regulatory submissions. Analytical, well-organized, and able to work across functions to resolve technical or compliance issues. Desired Skills Technical Skills Proficiency in chromatography (HPLC/UPLC), LC-MS, UV‑Vis, NMR, and sequence confirmation tools. Experience with automated or scale‑up synthesis platforms, lab instruments, and LIMS/electronic lab notebooks. Preferred Qualifications Experience with conjugation strategies (e.g., peptide-oligo, ligand-oligo constructs). Knowledge of global regulations (FDA, EMA, ICH) for biologics and oligo therapeutics. Process development or GMP exposure in peptide/oligo manufacturing settings. Based upon the location of this client partner, candidates located in EST are preferred. Consideration, however, will be given to exceptional candidates in other time zones located in the US and Canada. #LI-LB1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Provide labeling development and strategy, evaluate risks, and collaborate with global teams to align labeling with product strategy. | Requires 6-8 years of pharmaceutical labeling/regulatory experience, with expertise in CCDS, local labeling, and regulatory systems. | Job Description: • Drive the labeling development and strategy, in-line with overall global strategy. • Provide labeling expertise for Company Core Data Sheet (CCDS) and local labeling (USPI, SmPC and other). • Evaluate and communicate strategies and anticipate risks associated with labeling content and timelines. • Lead or contribute to cross-functional teams to align the development and maintenance of global labeling for assigned compounds. • Partner with Global Regulatory Affairs to ensure all labeling is aligned with product global strategy. • Support global Health Authority interaction strategy regarding all aspects of labeling. • Collaborate with global colleagues and partners as needed. • Develop clear communications for senior management and labeling stakeholders. Requirements: • BSc or advanced scientific degree (MSc, PhD or PharmD) preferred. • 6-8 years of relevant pharmaceutical Labeling/Regulatory experience. • Thorough understanding of scientific principles and regulatory systems, relevant to drug development. • Experience writing CCDS and local labeling documents for new products. • Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required. • Ability to prioritize and manage multiple high to medium complex projects simultaneously. • Strong attention to detail. • Preference for experience with IT systems; knowledge of Regulatory Information Management System (RIMS) and electronic document management system (EDMS); proficiency in MS Office suite. Benefits: • Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development

Lead global regulatory CMC strategy for peptide and oligonucleotide therapeutics, ensuring compliance and facilitating product approvals. | Requires 4-7 years of experience in peptide or oligonucleotide synthesis, analytical testing, and regulatory submissions, with proficiency in chromatography, LC-MS, NMR, and knowledge of FDA/ICH/USP standards. | Exceptional opportunity for a highly experienced analytical chemist to partner with a large global biopharmaceutical client and lead regulatory CMC strategy for cutting‑edge peptide and oligonucleotide therapeutics. In this role, the Regulatory Affairs Senior/Consultant will drive global regulatory strategy and submission activities for complex synthetic and nucleic acid–based products, partnering closely with R&D, CMC, clinical, and quality teams to ensure compliance with international standards and accelerate successful product approvals. Qualifications & Experience • Educational Background • Bachelor’s or Master’s degree in chemistry, biochemistry, pharmaceutical sciences, or related discipline. Ph.D. in organic chemistry is preferred if possible. • Technical & Regulatory Expertise • 4-7 years in peptide or oligonucleotide synthesis, purification, and analytical testing (HPLC, LC-MS, NMR). • Hands-on experience with solid-phase synthesis or phosphoramidite-based workflows. • Familiarity with purity, identity, sequence confirmation, and impurity profiling requirements per FDA/ICH/USP standards. • Regulatory & Professional Competencies • Strong understanding of regulatory requirements for synthetic peptides and oligonucleotides and ability to analyze guidelines and precedents. • Proven track record preparing CMC documents and regulatory submissions. • Analytical, well-organized, and able to work across functions to resolve technical or compliance issues. Desired Skills • Technical Skills • Proficiency in chromatography (HPLC/UPLC), LC-MS, UV‑Vis, NMR, and sequence confirmation tools. • Experience with automated or scale‑up synthesis platforms, lab instruments, and LIMS/electronic lab notebooks. • Preferred Qualifications • Experience with conjugation strategies (e.g., peptide-oligo, ligand-oligo constructs). • Knowledge of global regulations (FDA, EMA, ICH) for biologics and oligo therapeutics. • Process development or GMP exposure in peptide/oligo manufacturing settings. Based upon the location of this client partner, candidates located in EST are preferred. Consideration, however, will be given to exceptional candidates in other time zones located in the US and Canada. #LI-LB1 #LI-REMOTE

Lead and develop global pharmaceutical labeling strategies, ensuring compliance and alignment with regulatory requirements, while collaborating across teams and managing documentation. | Requires 6-8 years of pharmaceutical labeling/regulatory experience, with knowledge of CCDS, global labeling, and regulatory systems. | Exciting temporary labeling strategist role dedicated to one large client partnership! The Labeling Strategist will drive the labeling development and strategy, in-line with overall global strategy, and by providing labeling expertise for Company Core Data Sheet (CCDS) and local labeling (USPI, SmPC and other), from early-stage development through to product maintenance. Facilitates strategic development of labeling and labeling components by leading a diverse cross-functional labeling subteam through discussion and decisions. Evaluates and communicates strategies and anticipates risks associated with labeling content, timelines, labeling compliance and implementation. Responsibilities • Demonstrate high-level understanding of labeling content requirements, regulations, and guidance in support of labeling strategies worldwide, including key scientific, clinical, medical, and key messages and differentiation strategies. • Leads or contributes to cross functional teams across the organization, to drive and align the development and maintenance of global labeling (e.g. CCDS, regional product labels, and patient labeling) for assigned compounds. • Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product global strategy and key messaging. • Evaluate and communicate risks associated with CCDS content updates and implementation strategies. • Drive labeling for package labeling (mockups/artwork) development, update, and maintenance through collaboration with a cross-functional team. • Support global HA interaction strategy regarding all aspects of labeling, including submissions, responses to questions, and negotiations. • Demonstrate understanding of current labeling content requirements, regulations, and guidance to ensure all assigned compound labeling documents are accurate, consistent, and compliant. • Assess competitor labeling in the same therapeutic class, competitor labeling and labeling trends, proposing content as relevant to support optimized labeling • Manage and maintain labeling documents in document management systems; Manage label review and approval. • Author, contribute, and/or review labeling sections of various periodic reports (i.e., Annual Report, PSUR, PADER, etc.). • Support inspection readiness activities related to all global labeling components. • Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. • Collaborate with global colleagues, affiliates and Alliance partners, as needed. • Develop clear communications for senior management and labeling stakeholders, to streamline and facilitate label development, negotiations, and approval. • During HA reviews, continuously assess dossier review comments for potential labeling impact, development of alternate proposals, and negotiation strategies. • Support global HA interaction strategy to discuss key labeling elements • Lead response to Health Authority (HA) questions for labeling. Respond to labeling related inquiries from global Health Authorities in an efficient manner to meet required timelines. • Analyze and interpret new regulations and Guidance, as well as monitor and determine impact on product labeling. Qualifications Education and Experience • BSc or advanced scientific degree (MSc, PhD or PharmD) preferred. • 6-8 years of relevant pharmaceutical Labeling/Regulatory experience. • Thorough understanding of scientific principals and regulatory systems, relevant to drug development • Experience writing CCDS and local labeling documents for new products Knowledge and Skills • Solid understanding and practical knowledge of labeling regulatory requirements, regulations and guidance required • Solid understanding of implications of global labeling across the organization and globally • Solid understanding of the structure of product labeling • Experience in effectively/appropriately prioritizing and managing multiple high to medium complex projects simultaneously • Ability to work independently or in teams, globally. Ability to lead broad range of stakeholders at all levels internally and externally to the company. • Effective written and oral communication and organizational skills • Strong attention to detail • Solid aptitude for use of IT systems; preferable knowledge with Regulatory Information Management System (RIMS) and electronic document management system (EDMS); Proficiency in MS Office suite; Willing to learn additional applications • Ability to think strategically, communicate risks, and recommend innovative solutions to problem solving • Ability to recognize and escalate issues • The ideal candidate should be action-oriented, customer focused, ability to manage workloads and set priorities. In addition, he/she should be capable of dealing with ambiguity, be creative, and be comfortable working with multifunctional teams. Candidates located within the EST in the US or Canada are highly preferred due to the client's locations. #LI-REMOTE

Manage country-specific clinical trial operations, including regulatory submissions, budget oversight, and team coordination. | Experience in clinical trial management, regulatory environment, and team leadership, with strong organizational and negotiation skills. | When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. This role if for COM-F Job Purpose: The Clinical Operations Manager (COM)/Clinical Operations Manager Finance (COM-F)/ Clinical Operations Manager Regulatory (COM-R) is responsible for the following: • Performance and compliance for assigned protocols in a country in compliance with International Council for Harmonization (ICH) / Good Clinical Practice (GCP) and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally. • Budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready under the oversight of the Senior Clinical Operations Manager (SCOM) or Clinical Research Director (CRD). This position has significant impact on the delivery of country specific trial commitments and objectives especially during study start-up. Key Accountabilities: Study Management • Manages country deliverables, timelines, and results for assigned protocols to meet country commitments including quality and compliance in assigned protocols in country • Oversees Clinical Trial Coordinators as applicable • Coordinates and liaises with Clinical Research Managers (CRMs), Clinical Research Associates (CRAs) and Clinical Trial Coordinators (CTCs), Finance and Legal if appropriate to ensure country deliverables are obtained for submissions, budgets, Clinical Trial Research Agreements (CTRAs) and local milestones • Collaborates closely with Headquarter to align country timelines for assigned protocols • Provides support and oversight to local vendors as applicable Oversees and coordinates local processes, clinical and ancillary supplies, import and export requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems • Delivers clinical and financial contracts within fair market value through continual interaction with local clinical teams • Works in partnership internally with Global Clinical Trial Organization (GCTO) country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, Headquarter (HQ) functional areas and externally with vendors and sites, Internal Review Board (IRB) / Independent Ethics Committee (IEC) and Regulatory Authorities in submission and approval related interactions Finance Management (as applicable) • Has ownership of country and site budgets including development, negotiation, and completion of Clinical Trial Research Agreements (CTRA) • Oversees and tracks clinical research-related payments and payment reconciliation at study close-out • Oversees Foreign Corrupt Practices Act (FCPA), Denied Party Screening/Office of Foreign Assets Control (DPS/OFAC) and maintenance of financial systems and financial forecasting in conjunction with Senior Clinical Operations Manager, Clinical Research Director and other roles • Influences investigators, external partners, and country operations to adhere to budget targets and agreed payment timelines Regulatory Management (as applicable) • Executes and oversees clinical trial country submissions and approvals for assigned protocols • Develops local language materials including local language Informed Consents and translations • Interacts with IRB/ IEC and Regulatory Authority for assigned protocols Team development and support • Contributes or leads initiatives and projects adding value to the business. • Contributes strongly to the Clinical Operations Manager team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. • Contributes to Clinical Operations Manager team knowledge by acting as a buddy/mentor and sharing best practices as appropriate/required Compliance with Parexel standards • Complies with required training curriculum • Completes timesheets accurately as required • Submits expense reports as required • Updates CV as required • Maintain a working knowledge of and comply with Parexel processes, ICH- GCPs and other applicable requirements Skills: • Strong coordination and organizational skills. • Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up • Ability to indirectly influence investigators, vendors, external partners, and country managers to address and resolve issues, with minimal support from the SCOM or manager • Ability to make decisions independently with limited oversight from SCOM or manager. • Requires a strong understanding of local regulatory environment • Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally • Ability to lead a team of CTCs as applicable • Problem solving is essential. Requires ability to proactively identify issues and risks, analyze root cause and propose solutions and escalate to management as applicable. Examples include: Issues in budget/CTRA negotiation o Quality and compliances issues o Regulatory and legal issues o Issues related to functional area deliverables that could jeopardize protocol milestones • Effective and efficient time management, organizational and interpersonal skills, and conflict management skills • High sense of accountability and urgency to prioritize deliverables • Strong communication, leadership, and negotiation skills as well as excellent influencing and training/ mentoring skills • Ability to focus on multiple deliverables and protocols simultaneously • Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people • Positive mindset, growth mindset, capable of working independently and self – driven. • Ability to directly influence site staff • Excellent verbal and written influencing and training/mentoring skills, in local language and English • Minimal travel required. #LI-LG4 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Oversee and lead the Patient Safety services, ensuring compliance, process improvement, and strategic direction. | Extensive experience in pharmaceutical or CRO safety operations, management, and regulatory knowledge, with strong leadership and project management skills. | Job Description: • Oversee the management and leadership of Parexel's Patient Safety pillar • Work with senior management, customers, business development, and project teams providing oversight of processes and functions related to Patient Safety Services • Lead operational level planning with significant business oversight • Drive positive change through continuous process improvement programs • Contribute to the leadership and direction of the Business Unit (BU) • Lead the operational contribution to proposal development and business development activities at a project level • Provide senior operational and strategic direction for Safety Project Leadership • Mentor, support and direct the functional team to develop robust patient engagement strategies • Identify knowledge gaps and develop plans to build skills across the business • Facilitate functional team metrics collection and case study creation • Provide expertise in Safety Project Leadership and project management best practices • Strive to ensure internal and external clients receive the required deliverables within stipulated timelines and budget Requirements: • Minimum 13+ years of pharmaceutical and/or CRO experience including but not limited to areas of focus in clinical operations, sales and decentralized clinical trials/direct to patient studies • 7-10 years of management experience, including direct project management or program oversight Benefits: • Excellent leadership and line management skills • Excellent knowledge of drug safety and the drug development process • Excellent knowledge of and ability to interpret and apply global safety regulations • Experience in data analysis, evaluation of safety data and the preparation of safety reports preferred • Excellent team / project leadership and delegation skills • Ability to train and mentor people • Excellent presentation skills • Excellent interpersonal skills • Excellent time management skills • Client focused approach to work • Experience with Pharmacovigilance related computing systems • Clinical Research or Pharmacovigilance knowledge /qualifications • Computer proficiency, ability to work with web-based applications and familiarity with the Windows operating system and Microsoft Office apps • Ability to comprehend various regulatory or client requests and be able to strategize a handling approach • Flexible attitude with respect to work assignments and new learnings • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail • Willingness to work in a matrix environment and to value the importance of teamwork

Oversee clinical trial operations, coordinate with vendors and internal teams, and ensure compliance and timely delivery of protocols. | Strong organizational, negotiation, and leadership skills with knowledge of local regulatory processes and experience managing teams. | Job Description: • Manages country deliverables, timelines, and results for assigned protocols to meet country commitments including quality and compliance in assigned protocols in country • Oversees Clinical Trial Coordinators as applicable • Coordinates and liaises with Clinical Research Managers (CRMs), Clinical Research Associates (CRAs) and Clinical Trial Coordinators (CTCs), Finance and Legal if appropriate to ensure country deliverables are obtained for submissions, budgets, Clinical Trial Research Agreements (CTRAs) and local milestones • Collaborates closely with Headquarter to align country timelines for assigned protocols • Provides support and oversight to local vendors as applicable • Oversees and coordinates local processes, clinical and ancillary supplies, import and export requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. • Delivers clinical and financial contracts within fair market value through continual interaction with local clinical teams • Works in partnership internally with Global Clinical Trial Organization (GCTO) country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, Headquarter (HQ) functional areas and externally with vendors and sites, Internal Review Board (IRB) / Independent Ethics Committee (IEC) and Regulatory Authorities in submission and approval related interactions Requirements: • Strong coordination and organizational skills. • Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up • Ability to indirectly influence investigators, vendors, external partners, and country managers to address and resolve issues, with minimal support from the SCOM or manager • Ability to make decisions independently with limited oversight from SCOM or manager. • Requires a strong understanding of local regulatory environment • Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally • Ability to lead a team of CTCs as applicable • Problem solving is essential. Requires ability to proactively identify issues and risks, analyze root cause and propose solutions and escalate to management as applicable. • Effective and efficient time management, organizational and interpersonal skills, and conflict management skills • High sense of accountability and urgency to prioritize deliverables • Strong communication, leadership, and negotiation skills as well as excellent influencing and training/ mentoring skills Benefits: • Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options

Oversee and lead the Patient Safety Project Leadership function, develop strategies, and ensure delivery of safety projects aligned with organizational goals. | Extensive experience in pharmaceutical or CRO safety operations, management experience, and knowledge of drug safety regulations and data analysis. | When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Home Based US As Executive Director, Patient Safety you will oversee the management and leadership of Parexel's Patient Safety pillar, team or functions within Patient Safety organization. In this case, the Patient Safety Project Leadership Organization. The Executive Director will work with senior management, customers, business development, and project teams providing oversight of processes and functions related to the delivery of a program or portfolio of Patient Safety Services. You will lead operational level planning with significant business oversight, drive ‘positive change’ throughout Parexel through continuous process improvement programs, as well as make significant contributions to the leadership of the Business Unit (BU) and the development of the strategy and direction of the BU. The Executive Director will lead the operational contribution to proposal development and business development activities at a project level. Key Accountabilities: Leadership Leads a business function (Patient Safety Project Leadership) within the Patient Safety organization. Is accountable for setting the business function strategy and delivery against that strategy. Provides leadership and guidance across initiatives, facilitates discussions, and contributes to strategic planning to enable and support optimal end-to-end delivery of Patient Safety projects under their remit. Supports the achievement of Patient Safety organization financial targets. Responsible for the strategic planning of Safety Project Leadership to enhance the financial and operational performance of the wider department including plans for expanding departmental revenue, margin, and resources. Develops and implements appropriate cost reduction solutions within span to improve profitability. Demonstrates a deep understanding of the current business offerings and stays current on all aspects of business intelligence. Continually challenges the status quo and encourages incremental improvements in strategy and efficiency of the Patient Safety organization. Demonstrates leadership within the Patient Safety organization and wider Company, including maintaining an active external brand and thought leadership status. Team Management Provides senior operational and strategic direction for Safety Project Leadership. Mentor, support and direct functional team within span to develop robust patient engagement strategies and deliver programs to client specifications. Identify knowledge gaps and develop and implement plans to build skills for self, team and operational teams across the business. Holds team and individuals accountable for achieving financial and operational targets and corporate business goals including closure of quality issues. Oversight of employees including goal setting and measurement, approval of timesheets, and performance reviews. Metrics Management Facilitates functional team metrics collection and case study creation to support the Patient Safety organization including monthly KPI metrics. Identifies and proposes strategies, procedures, systems, technology, or efficiencies to improve productivity of own span and Patient Safety team. Client Management & New Business Generation Provides support to the Parexel business operations teams in the development of proposals and the bid defense process. Acts as an elevated point of contact for strategic partnerships and key clients. Technical Directs, leads and provides guidance to the teams in all aspects of Safety Project Leadership Provide expertise in Safety Project Leadership and project management best practices Quality and Compliance Strive to ensure internal and external clients receive the required deliverables within stipulated timelines and budget Ensure projects assigned to line reports are completed with quality, according to SOPs, and regulatory guidelines Skills: Excellent leadership and line management skills Excellent knowledge of drug safety and the drug development process Excellent knowledge of and ability to interpret and apply global safety regulations Experience in data analysis, evaluation of safety data and the preparation of safety reports preferred Excellent team / project leadership and delegation skills Ability to train and mentor people Excellent presentation skills Excellent interpersonal skills Excellent time management skills Client focused approach to work Experience with Pharmacovigilance related computing systems Clinical Research or Pharmacovigilance knowledge /qualifications Computer proficiency, ability to work with web-based applications and familiarity with the Windows operating system and Microsoft Office apps Ability to comprehend various regulatory or client requests and be able to strategize a handling approach Flexible attitude with respect to work assignments and new learnings Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Willingness to work in a matrix environment and to value the importance of teamwork Knowledge and Experience: Minimum 13+ years of pharmaceutical and/or CRO experience including but not limited to areas of focus in clinical operations, sales and decentralized clinical trials/direct to patient studies 7-10 years of management experience, including direct project management or program oversight Education: Requires BA/BS degree or equivalent combination of education and experience or equivalent related degree and/or experience, plus significant executive and/or senior management experience, preferably in worldwide clinical research, pharmaceutical, or biotechnology company. A strong background in Safety Operations execution is desirable. Minimum of thirteen (13) years of related experience, including seven to ten (7-10) years of progressive management experience, including direct project management or program oversight. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Managing clinical trial country deliverables, budgets, regulatory submissions, and team oversight. | Extensive experience in clinical operations, regulatory affairs, or related fields, with leadership skills and knowledge of clinical trial processes. | This role if for COM-F Job Purpose: The Clinical Operations Manager (COM)/Clinical Operations Manager Finance (COM-F)/ Clinical Operations Manager Regulatory (COM-R) is responsible for the following: • Performance and compliance for assigned protocols in a country in compliance with International Council for Harmonization (ICH) / Good Clinical Practice (GCP) and country regulations, Client policies and procedures, quality standards and adverse event reporting requirements internally and externally. • Budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready under the oversight of the Senior Clinical Operations Manager (SCOM) or Clinical Research Director (CRD). This position has significant impact on the delivery of country specific trial commitments and objectives especially during study start-up. Key Accountabilities: Study Management • Manages country deliverables, timelines, and results for assigned protocols to meet country commitments including quality and compliance in assigned protocols in country • Oversees Clinical Trial Coordinators as applicable • Coordinates and liaises with Clinical Research Managers (CRMs), Clinical Research Associates (CRAs) and Clinical Trial Coordinators (CTCs), Finance and Legal if appropriate to ensure country deliverables are obtained for submissions, budgets, Clinical Trial Research Agreements (CTRAs) and local milestones • Collaborates closely with Headquarter to align country timelines for assigned protocols • Provides support and oversight to local vendors as applicable Oversees and coordinates local processes, clinical and ancillary supplies, import and export requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems • Delivers clinical and financial contracts within fair market value through continual interaction with local clinical teams • Works in partnership internally with Global Clinical Trial Organization (GCTO) country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, Headquarter (HQ) functional areas and externally with vendors and sites, Internal Review Board (IRB) / Independent Ethics Committee (IEC) and Regulatory Authorities in submission and approval related interactions Finance Management (as applicable) • Has ownership of country and site budgets including development, negotiation, and completion of Clinical Trial Research Agreements (CTRA) • Oversees and tracks clinical research-related payments and payment reconciliation at study close-out • Oversees Foreign Corrupt Practices Act (FCPA), Denied Party Screening/Office of Foreign Assets Control (DPS/OFAC) and maintenance of financial systems and financial forecasting in conjunction with Senior Clinical Operations Manager, Clinical Research Director and other roles • Influences investigators, external partners, and country operations to adhere to budget targets and agreed payment timelines Regulatory Management (as applicable) • Executes and oversees clinical trial country submissions and approvals for assigned protocols • Develops local language materials including local language Informed Consents and translations • Interacts with IRB/ IEC and Regulatory Authority for assigned protocols Team development and support • Contributes or leads initiatives and projects adding value to the business. • Contributes strongly to the Clinical Operations Manager team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. • Contributes to Clinical Operations Manager team knowledge by acting as a buddy/mentor and sharing best practices as appropriate/required Compliance with Parexel standards • Complies with required training curriculum • Completes timesheets accurately as required • Submits expense reports as required • Updates CV as required • Maintain a working knowledge of and comply with Parexel processes, ICH- GCPs and other applicable requirements Skills: • Strong coordination and organizational skills. • Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up • Ability to indirectly influence investigators, vendors, external partners, and country managers to address and resolve issues, with minimal support from the SCOM or manager • Ability to make decisions independently with limited oversight from SCOM or manager. • Requires a strong understanding of local regulatory environment • Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally • Ability to lead a team of CTCs as applicable • Problem solving is essential. Requires ability to proactively identify issues and risks, analyze root cause and propose solutions and escalate to management as applicable. Examples include: Issues in budget/CTRA negotiation o Quality and compliances issues o Regulatory and legal issues o Issues related to functional area deliverables that could jeopardize protocol milestones • Effective and efficient time management, organizational and interpersonal skills, and conflict management skills • High sense of accountability and urgency to prioritize deliverables • Strong communication, leadership, and negotiation skills as well as excellent influencing and training/ mentoring skills • Ability to focus on multiple deliverables and protocols simultaneously • Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people • Positive mindset, growth mindset, capable of working independently and self – driven. • Ability to directly influence site staff • Excellent verbal and written influencing and training/mentoring skills, in local language and English • Minimal travel required. #LI-LG4 #LI-REMOTE

Oversee and lead the Patient Safety organization, develop strategy, manage teams, and ensure quality and compliance. | Extensive management experience in clinical or pharmaceutical safety, deep knowledge of drug safety regulations, and experience in pharmacovigilance or related fields. | Home Based US As Executive Director, Patient Safety you will oversee the management and leadership of Parexel's Patient Safety pillar, team or functions within Patient Safety organization. In this case, the Patient Safety Project Leadership Organization. The Executive Director will work with senior management, customers, business development, and project teams providing oversight of processes and functions related to the delivery of a program or portfolio of Patient Safety Services. You will lead operational level planning with significant business oversight, drive ‘positive change’ throughout Parexel through continuous process improvement programs, as well as make significant contributions to the leadership of the Business Unit (BU) and the development of the strategy and direction of the BU. The Executive Director will lead the operational contribution to proposal development and business development activities at a project level. Key Accountabilities: Leadership • Leads a business function (Patient Safety Project Leadership) within the Patient Safety organization. Is accountable for setting the business function strategy and delivery against that strategy. • Provides leadership and guidance across initiatives, facilitates discussions, and contributes to strategic planning to enable and support optimal end-to-end delivery of Patient Safety projects under their remit. • Supports the achievement of Patient Safety organization financial targets. Responsible for the strategic planning of Safety Project Leadership to enhance the financial and operational performance of the wider department including plans for expanding departmental revenue, margin, and resources. Develops and implements appropriate cost reduction solutions within span to improve profitability. • Demonstrates a deep understanding of the current business offerings and stays current on all aspects of business intelligence. Continually challenges the status quo and encourages incremental improvements in strategy and efficiency of the Patient Safety organization. • Demonstrates leadership within the Patient Safety organization and wider Company, including maintaining an active external brand and thought leadership status. Team Management • Provides senior operational and strategic direction for Safety Project Leadership. • Mentor, support and direct functional team within span to develop robust patient engagement strategies and deliver programs to client specifications. • Identify knowledge gaps and develop and implement plans to build skills for self, team and operational teams across the business. • Holds team and individuals accountable for achieving financial and operational targets and corporate business goals including closure of quality issues. • Oversight of employees including goal setting and measurement, approval of timesheets, and performance reviews. Metrics Management • Facilitates functional team metrics collection and case study creation to support the Patient Safety organization including monthly KPI metrics. • Identifies and proposes strategies, procedures, systems, technology, or efficiencies to improve productivity of own span and Patient Safety team. Client Management & New Business Generation • Provides support to the Parexel business operations teams in the development of proposals and the bid defense process. • Acts as an elevated point of contact for strategic partnerships and key clients. Technical • Directs, leads and provides guidance to the teams in all aspects of Safety Project Leadership • Provide expertise in Safety Project Leadership and project management best practices Quality and Compliance • Strive to ensure internal and external clients receive the required deliverables within stipulated timelines and budget • Ensure projects assigned to line reports are completed with quality, according to SOPs, and regulatory guidelines Skills: • Excellent leadership and line management skills • Excellent knowledge of drug safety and the drug development process • Excellent knowledge of and ability to interpret and apply global safety regulations • Experience in data analysis, evaluation of safety data and the preparation of safety reports preferred • Excellent team / project leadership and delegation skills • Ability to train and mentor people • Excellent presentation skills • Excellent interpersonal skills • Excellent time management skills • Client focused approach to work • Experience with Pharmacovigilance related computing systems • Clinical Research or Pharmacovigilance knowledge /qualifications • Computer proficiency, ability to work with web-based applications and familiarity with the Windows operating system and Microsoft Office apps • Ability to comprehend various regulatory or client requests and be able to strategize a handling approach • Flexible attitude with respect to work assignments and new learnings • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail • Willingness to work in a matrix environment and to value the importance of teamwork Knowledge and Experience: • Minimum 13+ years of pharmaceutical and/or CRO experience including but not limited to areas of focus in clinical operations, sales and decentralized clinical trials/direct to patient studies • 7-10 years of management experience, including direct project management or program oversight Education: • Requires BA/BS degree or equivalent combination of education and experience or equivalent related degree and/or experience, plus significant executive and/or senior management experience, preferably in worldwide clinical research, pharmaceutical, or biotechnology company. A strong background in Safety Operations execution is desirable. Minimum of thirteen (13) years of related experience, including seven to ten (7-10) years of progressive management experience, including direct project management or program oversight. #LI-REMOTE

Manage and oversee clinical study activities including planning, vendor management, data quality, budget, and regulatory compliance in alignment with global study plans. | Bachelor’s degree with 4+ years clinical trial experience, proficiency in clinical trial systems and MS Office, knowledge of ICH GCP, leadership skills, attention to detail, and budget awareness. | PXL has an exciting opportunity for a Clinical Study Associate Manager (CSAM)! The Clinical Study Associate Manager (CSAM) Service supports the Clinical Study Lead by taking responsibility for areas of clinical trial delivery. The Clinical Study Associate Manager works with the study team internally and externally with vendors such as CROs in feasibility, planning, initiation, maintenance and closeout of clinical projects according to GCP, ICH, CFR and Standard Operating Procedures (SOPs) and ICH/GCP. This Service applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) the balance of direct execution versus oversight of CROs deliverables will vary accordingly. CSAM Duties The Clinical Study Associate Manager perform the following Services: • May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignment with the global study plans and may contribute to global planning and management of the study • Contributes to risk assessment and helps identify risk mitigation strategies • Supports feasibility assessment to select relevant regions and countries • Oversees and provides input to the development of study specific documentation including but not limited to: case report form (CRF), data management plan, monitoring plan, monitoring oversight plan, etc. • Reviews site level informed consents and other patient-facing study start-up materials • Oversees setting up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS) and Trial Master File (TMF) Contributes to investigator meeting preparation and execution • Oversees engagement, contracting and management of required vendors for the study • Oversees and provides input to study drug and clinical supplies forecasting, drug accountability and drug reconciliation • Provides regular status reports to stakeholders as requested by the Clinical Study Lead • Contributes to development of and oversees implementation of recruitment and retention strategies • Monitors progress for site activation and monitoring visits • Supports data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites • Escalates data flow and data quality issues to Clinical Study Lead • Oversees the execution of the specific clinical study deliverables against planned timelines • Escalates issues related to timelines or budget to Clinical Study Lead • Supports accurate budget management and scope changes • Contributes to clinical project audit and inspection readiness throughout the study lifecycle • Supports internal and external inspection activities and contributes to CAPAs as required • Manages aspects of study close-out activities including but not limited to database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability • May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring CSAM Requirements • Bachelor’s degree and minimum 4 years of relevant experience • Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS. • Knowledge of ICH GCP and relevant regulatory guidelines/directives • Demonstrated interpersonal & leadership skills • Attention to details for the ability to deliver on specific study activities • Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization • Budget awareness with the ability to participate in various aspects of budget management • Effective communication skills via verbal, written and presentation abilities #LI-KW1 #LI-REMOTE

Support patient recruitment and retention team with administrative tasks, document management, vendor reporting, and clinical systems projects. | 2-5 years clinical research patient recruitment experience, pharmaceutical/biotech/CRO background, bachelor's degree, strong organizational and communication skills. | Job Summary: Parexel is seeking a Patient Recruitment & Retention Specialist to join our dynamic FSP team. This role will be key in supporting the successful implementation of patient recruitment and retention efforts across programs. The primary role is providing general support to the Patient Recruitment & Retention team in delivering and maintaining the team’s objectives. The position offers significant learning and growth opportunities. Key Responsibilities: • Provides general support to the Patient Recruitment & Retention expertise area in delivering and maintaining the team’s objectives • Supports the Patient Recruitment & Retention team with administrative activities including but not limited to updating internal status reports, meeting agendas and minutes, organizing teleconferences, reviewing / filing vendor reports, finance tracking, contracting / SOW development and processing, maintaining internal ROI reporting of team efforts, and supporting internal and external review / approval clinical & MLR process and related documentation tracking • Manages Patient Recruitment material approvals, printing and shipping • Assist with vendor reporting / tracking and ensure all files are up to date with clear history of activities and decisions • Partner with Patient Recruitment Managers and study team members to file documents in the electronic Trial Master File (eTMF) for relevant projects according to applicable study specific requirements and Standard Operating Procedures • Assist with the development and review of content and participate in UAT (User Acceptance Testing), as needed • May contribute to the development and/or review of content for presentations and operations plans for programs • Assist with other clinical systems enhancements/projects and department initiatives as necessary to meet business needs such as development of training materials Skills and Requirements: • Based in East Coast US • 2-5 years of hands on clinical research Patient Recruitment experience. • Direct experience working in a pharmaceutical, biotech, contract research organization, patient recruitment company. • Proficiency in Microsoft Office Suite • Strong organizational, interpersonal, and team-oriented skills. • Excellent verbal, written, communication and time management skills. • Ability to perform several tasks simultaneously to meet deadlines in a dynamic environment. • Ability to be flexible, adapt to change, as well as work as part of a team in a matrix environment under close supervision Education: • Bachelor's degree is required #LI-REMOTE

Write, edit, and manage clinical regulatory documents ensuring compliance with guidelines and timelines while collaborating with cross-functional teams. | 15+ years pharmaceutical medical writing experience with expertise in regulatory documents, ICH guidelines, and ability to work in matrix teams. | Job Summary: The Principal Medical Writer is responsible for writing and overseeing the completion of a broad range of documents in support of company products and projects. This individual will work with the lead and/or program medical writer and independently to develop messages and write, substantively rewrite, and edit documents for clarity and accuracy, ensuring high quality. This individual will help manage project documents and timelines, as well as ensuring that documents comply with International Committee on Harmonization guidelines, SOPs, Good Clinical Practices, and Good Publication Practices. As a study team member, this individual will work with domestic and international colleagues across R&D (as appropriate).to ensure that documents meet the company’s objectives. Key Accountabilities: • Write and edit clinical regulatory documents for clarity, and accuracy according to client standards.. • Work with lead writer and project team to develop document messages and data presentations within submission timelines to meet company objectives. • Provide writing support for a wide range of documents, including but not limited to investigator’s brochures, clinical study protocols and reports, integrated summaries, literature reviews, and SOPs. • Ensure that documents comply with International Conference on Harmonization guidelines, SOPs, and Good Clinical Practices. Requirements: • At least 15 years of medical writing experience in the pharmaceutical industry • Ability to write and edit complex material to ensure accuracy and clarity • Experience with a variety of regulatory and clinical documents • Experience in a matrix team environment • Excellent written and oral communication skills and demonstrated problem-solving abilities • Ability to handle multiple projects and short timelines • Ability to work cooperatively with colleagues in a wide range of disciplines • Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents Education: • BA/BS, Advanced degree preferred #LI-LO1 #LI-REMOTE