Description
Syneos Health is seeking a Sponsor Dedicated Protocol Medical Writer II to work remotely from Canada, US, UK, or Serbia.
The role involves partnering closely with Clinical Scientists and focusing on Protocols and Protocol Amendments.
Key responsibilities:
- Lead the clear and accurate completion of medical writing deliverables
- Manage medical writing activities associated with individual studies
- Coordinate quality and editorial reviews
- Act as peer reviewer for internal team
- Interact and build good working relations with clients and peers
- Perform online clinical literature searches and comply with copyright requirements
- Identify and propose solutions to resolve issues
- Mentor and lead less experienced medical writers on complex projects
- Develop deep expertise on key topics in the industry and regulatory requirements
- Aware of budget specifications for assigned projects
- Complete required administrative tasks within specified timeframes
- Minimal travel may be required (less than 25%)
Qualifications:
- 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
The company offers various benefits and opportunities for career development and growth.