Description
Syneos Health is seeking a Dedicated Senior Medical Writer (Regulatory Submission Documents) to work remotely in the US or Canada.
The successful candidate will partner closely with Clinical Scientists and focus on Protocols and Protocol Amendments.
Key responsibilities:
- Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately
- Complete a variety of documents, including clinical study protocols, clinical study reports, patient narratives, and regulatory submissions
- Adhere to established regulatory standards, including ICH E3 guidelines and company standard operating procedures
- Coordinate quality and editorial reviews, and lead team document reviews
- 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 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
Requirements:
- 3-5 years of relevant experience in medical writing, with proven experience in Protocol writing
- Experience working in the biopharmaceutical, device, or contract research organization industry
- Experience with late development, Oncology/Hematology/Cell therapy, and Veeva/CARA
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and good publication practices
- Extensive knowledge of English grammar and ability to communicate clearly
Benefits:
- Salary range: $80,600.00 - $145,000.00
- Company car or car allowance
- Health benefits, including Medical, Dental, and Vision
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Flexible paid time off (PTO) and sick time