Description
Syneos Health is seeking a Sponsor Dedicated Senior Medical Writer (Regulatory Submission Documents) to work remotely from Canada.
The successful candidate will partner closely with Clinical Scientists and focus on Protocols and Protocol Amendments.
Key responsibilities include:
- Leading the clear and accurate completion of medical writing deliverables
- Completing a variety of documents, including clinical study protocols, clinical study reports, and regulatory submissions
- Adhering to established regulatory standards, including ICH E3 guidelines
- Coordinating quality and editorial reviews
- Acting as peer reviewer for internal team
- Interacting and building good working relations with clients and stakeholders
- Performing online clinical literature searches and complying with copyright requirements
- Identifying and proposing solutions to resolve issues
- Mentoring and leading less experienced medical writers on complex projects
- Developing deep expertise on key topics in the industry and regulatory requirements
- Managing budget specifications for assigned projects
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
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and good publication practices
- Experience writing relevant document types
- Experience in working with Veeva/CARA
- Extensive knowledge of English grammar and ability to communicate clearly
Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.