Sr. Medical Writer (Regulatory)

Sr. Medical Writer (Regulatory) at Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model places the customer and the patient at the center, continuously simplifying and streamlining work to be easier to collaborate with and easier to be a part of. Whether you join us in a Functional Service Provider partnership or a full‑service environment, you’ll collaborate with passionate problem solvers, innovate as a team, and help customers achieve their goals. We are agile, driven, and dedicated to changing lives.

Why Syneos Health

• We develop our people through career development, progression, supportive line management, technical and therapeutic area training, peer recognition, and total rewards.
• We are committed to a Total Self culture where you can authentically be yourself.
• We continuously build a company that everybody wants to work for by fostering diversity of thought, background, culture, and perspective.

Job Responsibilities

• Lead the clear and 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. Lead the resolution of client comments.
• Complete a variety of documents including clinical study protocols and amendments, clinical study 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 and eCTD submissions, journal manuscripts, abstracts, posters, and scientific meeting presentations.
• Adhere to regulatory standards such as ICH E3 guidelines and company SOPs, client standards, and approved templates, ensuring on‑time and on‑budget delivery.
• Coordinate quality and editorial reviews, manage source documentation, and lead team document reviews.
• Act as peer reviewer to ensure scientific content, clarity, consistency, and format.
• Review statistical analysis plans and table/figure/listing specifications for content and consistency; provide feedback on statistical output and document needs.
• Interact with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce deliverables.
• Perform online clinical literature searches and comply with copyright requirements.
• Identify and propose solutions to resolve issues, provide technical support, training, and consultation, and contribute to internal material and process development.
• Mentor and lead less experienced writers on complex projects.
• Develop deep expertise on key topics and regulatory guidelines relevant to medical writing.
• Manage budget specifications, working within budgeted hours and communicating status and changes to leadership.
• Complete required administrative tasks within specified timeframes.
• Perform additional duties as assigned.
• Minimal travel may be required (less than 25%).

At Syneos Health, we provide an environment and culture where our people can thrive, develop, and advance. Benefits may include a company car or allowance, health benefits (medical, dental, vision), company match 401(k), eligibility for employee stock purchase plan, commission/bonus potential, and flexible paid time off. Paid sick time eligibility may vary by location in accordance with local requirements.

Salary Range: $0.00 – $0.00 (actual salary will vary based on qualifications and experience).

Get to know Syneos Health: Over the past 5 years, we have worked with 94% of all novel FDA‑approved drugs, 95% of EMA authority products, and over 200 studies across 73,000 sites and 675,000+ trial patients.

Tasks, duties, and responsibilities are not exhaustive. The Company may assign additional tasks at its discretion. Equivalent experience will be considered. The Company complies with the EU Equality Directive, the Americans with Disabilities Act, and provides reasonable accommodations when appropriate.