Description
Syneos Health is seeking a Sr Medical Writer - Sponsor-dedicated to join their team in a remote location. The successful candidate will 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, reports, and submissions
- Adhere to established regulatory standards, such as ICH E3 guidelines and company SOPs
- Coordinate quality and editorial reviews, and lead team document reviews
- Act as peer reviewer for internal team to ensure document scientific content and clarity
- Interact with clients, department heads, and peers to produce writing deliverables
- Perform online clinical literature searches and comply with copyright requirements
- Identify and propose solutions to resolve issues, and provide technical support and training
- 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
Qualifications:
- 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, and good publication practices
- Experience writing relevant document types
- Extensive knowledge of English grammar and ability to communicate clearly
The ideal candidate will have a strong background in medical writing, excellent communication skills, and the ability to work independently and as part of a team.