Description
Syneos Health is seeking a Senior Medical Writer (FSP) with experience in clinical document writing, specifically protocols, CSRs, and IBs.
The successful candidate will lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. They will manage medical writing activities associated with individual studies, coordinating with minimal supervision, and lead the resolution of comments from clients.
Key responsibilities include:
- Completing a variety of documents, such as clinical study protocols, clinical study reports, patient narratives, and investigator brochures
- Adhering to established regulatory standards, including ICH E3 guidelines and company standard operating procedures
- Coordinating quality and editorial reviews, and ensuring source documentation is managed appropriately
- Acting as peer reviewer for internal teams to ensure document scientific content, clarity, and consistency
- Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs
- Performing online clinical literature searches and complying with copyright requirements
- Identifying and proposing solutions to resolve issues, escalating as necessary
- Mentoring and leading less experienced medical writers on complex projects
- Developing deep expertise on key topics in the industry and regulatory requirements and guidelines that affect medical writing
- Managing budget specifications for assigned projects and communicating status and changes to medical writing leadership
The benefits for this position may include a company car or car allowance, health benefits, company match 401k, eligibility to participate in Employee Stock Purchase Plan, eligibility to earn commissions/bonus, and flexible paid time off (PTO) and sick time.
The salary range for this position is $80,600.00 - $175,700.00.