Description
Syneos Health is seeking a Medical Writer II (Narrative Writing) to join their team.
The successful candidate will have main experience in CSR safety narratives writing, including authoring, addressing review comments, and collaborating with teams.
Key responsibilities include:
- Compiling, writing, editing, and coordinating medical writing deliverables
- Completing various documents such as clinical study protocols, clinical study reports, patient narratives, and more
- 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, department head, and peers
- Performing online clinical literature searches and complying with copyright requirements
- Identifying and proposing solutions to resolve document issues
- Mentoring less experienced medical writers on projects
- Maintaining a strong working knowledge of drug development process, regulatory guidelines, industry standards, and best practices
Requirements include:
- Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred
- At least 2 years of relevant experience in science, technical, or medical writing
- Experience working in the biopharmaceutical, device, or contract research organization industry preferred
- Familiarity with FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly preferred
- Extensive knowledge of English grammar and ability to communicate clearly; familiarity with AMA Manual of Style
Syneos Health offers a range of benefits and opportunities for career development and growth.