Sr Medical Writer - Narrative Writer

Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success through clinical, medical affairs, and commercial insights.

About the Company

Our Clinical Development model places the customer and the patient at the center of everything we do. We streamline processes to make Syneos Health easier to work with and easier to work for, collaborating with passionate problem solvers across functional and full‑service environments.

Work Here Matters Everywhere

• We are passionate about developing our people through career development, supportive line management, technical and therapeutic area training, peer recognition, and a comprehensive total rewards program.
• We uphold a Total Self culture where everyone can authentically be themselves and feel supported globally.
• We continuously build the company we all want to work for, fostering a culture where diversity of thought, backgrounds, cultures, and perspectives creates belonging for all.

Job Responsibilities

• Lead the accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manage medical writing activities for individual studies, coordinating across departments with minimal supervision and resolving client comments.
• Produce a wide range of documents, including clinical study protocols, reports, patient narratives, investigator brochures, informed consents, plain language summaries, safety update reports, development plans, IND/NDA/eCTD submissions, journal manuscripts, abstracts, posters, and presentations for scientific meetings.
• Adhere to regulatory standards such as ICH E3, company SOPs, client standards, and approved templates, delivering projects on time and within budget.
• Coordinate quality and editorial reviews, manage source documentation, and conduct team document reviews as needed.
• Act as a peer reviewer to ensure scientific content, clarity, consistency, and proper format.
• Review statistical analysis plans and specifications for content, grammar, format, and consistency; provide feedback on statistical outputs.
• Build collaborative relationships with clients and cross‑functional teams in data management, biostatistics, regulatory affairs, and medical affairs.
• Conduct online clinical literature searches and honor copyright requirements.
• Identify and propose solutions to resolve issues, providing technical support, training, and consultation to colleagues; contribute to internal material development and process improvement.
• Mentor and lead less experienced medical writers on complex projects.
• Develop deep expertise on key industry topics and regulatory guidelines affecting medical writing.
• Monitor budget specifications, communicate status, and manage changes within budgeted hours.
• Complete administrative tasks within specified timeframes.
• Perform other work‑related duties as assigned.
• Minimal travel may be required (less than 25%).

Qualifications

• 3‑5 years of relevant experience in science, technical, or medical writing.
• Experience in the biopharmaceutical, device, or contract research organization industry.
• Strong understanding of FDA and ICH regulations, other regulatory guidelines, and good publication practices.
• Experience writing relevant document types such as reports, protocols, summaries, and submissions.
• Extensive knowledge of English grammar and the AMA Manual of Style.

Get to Know Syneos Health

Over the past 5 years, we have supported 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and more than 200 studies across 73,000 sites and 675,000+ trial patients.

Learn more about Syneos Health at SyneosHealth.com.

Additional Information

Tasks, duties, and responsibilities are not exhaustive. The Company may assign additional tasks as needed. Equivalent experience, skills, or education may be considered. All employment activities comply with applicable legislation, including the EU Equality Directive and the Americans with Disabilities Act, and reasonable accommodations are available as appropriate.

Summary

Roles within the Medical Writing family involve writing and editing manuscripts, clinical study reports, and regulatory submissions. Responsibilities include conducting literature searches, preparing statistical outputs, and engaging with regulatory agencies. The role may involve managing two or fewer employees and providing subject‑matter expertise to advance processes and policies.