Description
Syneos Health is seeking a Principal Medical Writer - Publications. As a Principal Medical Writer, you will lead the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately.
Responsibilities:
- Lead medical writing activities associated with individual studies, defining document strategy and coordinating medical writing activities within and across departments with minimal supervision.
- Complete a variety of documents, including clinical study protocols, clinical study reports, patient narratives, and abstracts.
- Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, and client standards.
- Advise clients and study teams on data presentation and production strategies to ensure client objectives are met and quality standards are maintained.
- Lead team document reviews and review documents for technical issues.
- Serve as expert peer reviewer for internal team, providing review comments to ensure client objectives are met and overall quality standards are maintained.
- Interact and build good working relationships with clients, department head, and team members in data management, biostatistics, regulatory affairs, and medical affairs.
- Perform online clinical literature searches and comply with copyright requirements.
- Identify and propose solutions to resolve issues, escalating as appropriate.
- Mentor and lead less experienced medical writers on complex documents.
- Develop deep expertise on key topics in the industry and regulatory requirements and guidelines that affect medical writing.
Benefits:
- Company car or car allowance
- Health benefits, including Medical, Dental, and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time