Sr. Medical Writer
Remote, CA 92121 US
- Independently or with minimal supervision write, edit, perform data verification, submit for review, and obtain approval for clinical and nonclinical regulatory documents including, but not limited to, clinical protocols, clinical study reports (CSRs), investigator's brochures, summary document, and safety reports
- Perform copy editing for grammar, punctuation, style, and internal consistency
- Collaborate effectively with other functional area authors to achieve submission schedules as prioritized by senior management
- Administer QC checks to ensure documents comply with FDA guidelines
- Help develop and manage medical writing processes, SOPs, and templates for key documents
- Help manage the functional review of study documents produced by other contract writers
- Keep abreast of professional information and technology through literature, symposia, and conferences
- Participate in departmental and cross-departmental initiatives. Provide innovation and be a resource for improving departmental processes.
- Provide expertise and guidance on document design and principles of good medical writing to department and product teams
- Experience writing protocols from the design phase
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.