Description
Syneos Health is seeking a Senior Medical Writer to join their FSP Team. This is a full-time permanent position that can be done remotely from anywhere in EMEA except Switzerland, Germany, and France.
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, coordinate medical writing activities within and across departments with minimal supervision, and lead the resolution of comments from clients.
Responsibilities:
- Lead the completion of various medical writing deliverables, including clinical study protocols, clinical study reports, patient narratives, and more
- Adhere to established regulatory standards, including ICH E3 guidelines and company standard operating procedures
- 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, overall consistency, and proper format
- Interact and build good working relations with clients, department head, and peers 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 projects
- Develop deep expertise on key topics in the industry and regulatory requirements and guidelines that affect medical writing
- Manage budget specifications for assigned projects and communicate status and changes to medical writing leadership
Qualifications:
- 3-5 years of relevant experience in science, technical, or medical writing
- Experience working in the biopharmaceutical, device, or contract research organization industry required
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
- Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style
- Veeva Vault experience is a must-have
- FSP or CRO experience preferred
Benefits:
- Career development and progression opportunities
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture that encourages authenticity