About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.

Job Responsibilities

• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
• Completes a variety of documents that may include clinical study protocols, clinical study reports (CSRs), patient narratives, investigator brochures (IBs), informed consents, annual reports, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, and NDA/eCTD submissions.
• Adheres to established regulatory standards, including ICH E3 guidelines, company SOPs, and client-approved templates.
• Coordinates quality and editorial reviews and ensures source documentation is managed appropriately.
• Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, and format.
• Interacts and builds good working relations with clients and peers in data management, biostatistics, regulatory affairs, and medical affairs.
• Mentors and leads less experienced medical writers on complex projects.
• Develops deep expertise on regulatory requirements and guidelines that affect medical writing.

Qualifications

• Minimum of 5 years of lead regulatory writing experience.
• Experience with Phase 2 and 3 clinical trials.
• Lead writer experience with protocols, submissions, clinical Summary of Safety (CTD) Modules 2.7.3 and 2.7.4, CSRs, IBs, Patient Narratives, Safety Aggregate Reports, Briefing books, ISE and ISS.
• Strong project management and client-facing experience.
• Excellent time management skills.
• Process experience is a significant advantage.

Benefits
We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include health benefits (Medical, Dental, and Vision), company match pension/401k, eligibility to participate in Employee Stock Purchase Plan, and flexible paid time off (PTO).

Syneos Health is an equal opportunity employer committed to diversity and inclusion in the workplace.