Senior Medical Writer – Regulatory
Updated: December 15, 2025
Location: United States – Indiana (Remote)
Job ID: 25104251
Employment Type: Full-Time
Job Function: Regulatory Medical Writing / Clinical Development
Career Level: Senior Individual Contributor
About Syneos Health
Syneos Health is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. By combining clinical development, medical affairs, and commercial expertise, Syneos Health delivers innovative, data-driven solutions that address modern global healthcare challenges.
With more than 29,000 professionals across 110 countries, Syneos Health operates a patient-centric Clinical Development model focused on scientific rigor, operational efficiency, and regulatory excellence throughout the drug development lifecycle.
Role Overview
Syneos Health is seeking an experienced Senior Medical Writer – Regulatory to lead the development of high-quality regulatory and clinical documents across global drug development programs. This role requires deep expertise in regulatory guidelines, strong scientific writing capabilities, and the ability to independently manage complex medical writing deliverables while collaborating across cross-functional teams.
The position offers the opportunity to work remotely while contributing to submissions supporting FDA, EMA, and other global health authorities.
Key Responsibilities
Lead the planning, writing, and delivery of regulatory and clinical documents, ensuring clarity, accuracy, and scientific integrity.
Manage medical writing activities for assigned studies, coordinating deliverables across departments with minimal supervision.
Lead the resolution of internal and client review comments and ensure timely document finalization.
Author and review a wide range of regulatory documents, including:
Clinical study protocols and amendments
Clinical study reports (CSRs)
Patient narratives
Investigator brochures
Informed consent forms
Annual and development safety reports
Plain language summaries
Periodic safety update reports (PSURs)
Clinical development plans
IND, NDA, and eCTD submission documents
Integrated summaries of safety and efficacy
Journal manuscripts, abstracts, posters, and scientific presentations
Ensure compliance with ICH guidelines (including ICH E3), regulatory authority requirements, company SOPs, and approved templates and style guides.
Coordinate editorial and quality control reviews and ensure appropriate source documentation management.
Serve as a peer reviewer to ensure scientific accuracy, consistency, formatting quality, and regulatory compliance.
Review statistical analysis plans and table, figure, and listing specifications to ensure alignment with document objectives.
Collaborate closely with data management, biostatistics, regulatory affairs, clinical operations, and medical affairs teams.
Conduct clinical literature searches in compliance with copyright requirements.
Identify risks, propose solutions, and escalate issues appropriately to medical writing leadership.
Provide technical guidance, mentoring, and training to junior medical writers on complex projects.
Contribute to internal process improvements, standard practices, and medical writing capabilities.
Manage assigned project budgets and timelines, communicating status and changes proactively.
Complete required administrative tasks within defined timelines.
Perform additional duties as assigned; minimal travel may be required (less than 25%).
Required Qualifications and Experience
Advanced degree in Life Sciences, Pharmacy, Medicine, or a related scientific discipline (PhD, MD, PharmD, or MSc preferred).
Minimum 6–8 years of experience in regulatory medical writing within a CRO, pharmaceutical, or biotechnology environment.
Demonstrated experience authoring documents for FDA, EMA, and other global regulatory submissions.
Strong working knowledge of ICH guidelines, particularly ICH E3, and global regulatory frameworks.
Proven ability to independently manage multiple writing projects and meet strict timelines.
Excellent written and verbal communication skills in English.
Strong attention to detail, analytical thinking, and problem-solving abilities.
Compensation and Benefits
Syneos Health offers a comprehensive total rewards package designed to support professional growth and work-life balance. Benefits may include:
Competitive base salary (final compensation based on qualifications, experience, and location)
Medical, dental, and vision insurance
Company-matched 401(k) retirement plan
Employee stock purchase plan eligibility
Performance-based bonus or incentive programs
Flexible paid time off and sick leave in compliance with federal, state, and local regulations
Company car or car allowance for eligible roles
Syneos Health Global Impact
Over the past five years, Syneos Health has supported:
94% of novel FDA-approved drugs
95% of EMA-authorized products
More than 200 clinical studies across 73,000 sites
Over 675,000 clinical trial participants worldwide
Equal Opportunity Statement
Syneos Health is committed to fostering a diverse, inclusive, and equitable workplace. Candidates with transferable skills or equivalent experience are encouraged to apply. Reasonable accommodations are provided in accordance with applicable laws, including the Americans with Disabilities Act.
How to Apply
Interested candidates may apply directly or join the Syneos Health Talent Network to receive updates on future regulatory medical writing opportunities.
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