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.
Responsibilities:
- Lead medical writing activities associated with individual studies, coordinating with minimal supervision
- Complete various documents, including clinical study protocols, clinical study reports, patient narratives, and more
- Adhere to established regulatory standards, such as ICH E3 guidelines and company SOPs
- Coordinate quality and editorial reviews, and ensure source documentation is managed appropriately
- Act as peer reviewer for internal team to ensure document scientific content, clarity, and consistency
- Interact and build good working relations with clients, department heads, and peers
- Perform online clinical literature searches and comply with copyright requirements
- Identify and propose solutions to resolve issues, escalating as necessary
- Mentor and lead less experienced medical writers on complex projects
- Develop deep expertise on key topics in the industry and regulatory requirements
- Manage budget specifications for assigned projects and communicate status and changes to leadership
Requirements:
- 3-5 years of relevant experience in regulatory writing
- Experience working in the biopharmaceutical, device, or contract research organization industry
- Strong understanding of EMA, FDA, and ICH regulations, and good publication practices
- Extensive knowledge of English grammar and ability to communicate clearly
- Familiarity with AMA Manual of Style
Benefits:
- Career development and progression opportunities
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture