Job Title
Senior Medical Writer (CSR, IB, Protocol Drafting)
About Syneos Health®
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization committed to accelerating customer success. With a focus on placing customers and patients at the center, we simplify and streamline processes to deliver impactful outcomes.
Global Presence: 29,000 employees across 110 countries
Track Record: Collaborated on 94% of FDA-approved novel drugs in the past 5 years, 95% of EMA-authorized products, and over 200 studies across 73,000 sites and 675,000+ trial patients.
Culture: Guided by our Total Self culture, fostering authenticity, inclusivity, and belonging.
Tagline: Work Here Matters Everywhere
Why Join Us
Career development and progression opportunities
Supportive and engaged leadership
Technical and therapeutic area training
Peer recognition and rewards programs
Commitment to diversity, inclusion, and employee well-being
Key Responsibilities
Lead the clear, accurate, and timely completion of medical writing deliverables.
Manage medical writing activities for individual studies with minimal supervision.
Draft and finalize diverse regulatory and scientific documents, including:
Clinical study protocols, amendments, reports, patient narratives
Annual reports, investigator brochures, informed consents, plain language summaries
Periodic safety update reports, clinical development plans, IND submissions
Integrated summary reports, NDA/eCTD submissions, manuscripts, abstracts, posters, and presentations.
Adhere to ICH E3, FDA, and other regulatory guidelines, company SOPs, client standards, and style guides.
Coordinate and conduct quality and editorial reviews; ensure accurate source documentation management.
Peer-review documents to ensure scientific accuracy, consistency, and format compliance.
Review statistical analysis plans (SAPs) and outputs, providing feedback to ensure alignment with document needs.
Collaborate effectively with clients, data management, biostatistics, regulatory affairs, and medical affairs teams.
Conduct clinical literature searches and ensure copyright compliance.
Identify and propose solutions for issues; provide training and technical support as needed.
Mentor junior medical writers on complex projects.
Develop deep expertise in therapeutic areas and regulatory requirements.
Work within assigned project budgets.
Qualifications
Education: Bachelor’s degree in a relevant scientific discipline (Master’s/PhD preferred).
Experience:
3–5 years in science, technical, or medical writing.
Experience in biopharmaceutical, device, or CRO industry required.
Proven experience with regulatory and scientific document types.
Knowledge & Skills:
Strong understanding of FDA/ICH regulations and good publication practices.
Excellent command of English grammar; proficiency with AMA Manual of Style.
Strong medical terminology knowledge and ability to interpret/present clinical data.
Proficiency in MS Office.
Excellent presentation, proofreading, time management, and collaboration skills.
Core Competencies & Focus Areas
Leading completion of medical writing deliverables
Managing and coordinating study-related writing activities
Adhering to regulatory standards and SOPs
Reviewing and editing statistical documents and outputs
Mentoring junior staff and sharing expertise
Building strong cross-functional and client relationships
Ensuring quality, clarity, and compliance in all deliverables
Additional Information
Responsibilities listed are not exhaustive; additional tasks may be assigned.
Equivalent skills, experience, or education may be considered.
The company complies with all relevant employment and equality legislation (e.g., ADA, EU Equality Directive).
This description does not constitute an employment contract.
How to Apply
Apply via Syneos Health Careers
Or join our Talent Network to stay updated on future opportunities.
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