Description
Syneos Health is seeking a Senior Medical Writer to lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
The successful candidate will manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
Key responsibilities include:
- Leading the resolution of comments from clients
- Completing a variety of documents, including clinical study protocols, clinical study reports, patient narratives, and investigator brochures
- Adhering to established regulatory standards, including ICH E3 guidelines
- Coordinating quality and editorial reviews
- Acting as peer reviewer for internal team
- Interacting and building good working relations with clients, department head, and peers
Requirements:
- 3-5 years of relevant experience in science, technical, or medical writing
- Experience working in the biopharmaceutical, device, or contract research organization industry
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices
- Extensive knowledge of English grammar and ability to communicate clearly
Benefits may include:
- Company car or car allowance
- Health benefits, including Medical, Dental, and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Flexible paid time off (PTO) and sick time
Salary Range: $80,600.00 - $175,700.00