About the Opportunity
We are currently partnered with a clinical-stage biopharmaceutical company that’s currently in need of a Medical Writer. This role is responsible for the management and oversight of assigned medical writing projects and be accountable for accountable for ensuring that all documents are written according to established templates and guidances. This is a fantastic opportunity to join a company that has several assets in various stages of clinical trials for solid tumor and hematologic indications.
The annual base salary range is $130,000 to $180,000. Actual compensation offered to the successful candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level, among other things. Details about eligibility for bonus compensation (if applicable) will be finalized at the time of offer.
- Write, edit and/or manage the production of high-quality clinical documentation including clinical study protocols, synopses, and clinical study reports for submission to regulatory authorities in support of marketing applications and BLAs.
- Act as a member of clinical trial teams
- Act as a documentation specialist in clinical trial teams
- Follow and track clinical documentation milestones
- Write/edit other strategic documents, as required
- Minimum of a Master’s degree in a life sciences discipline
- Minimum 10+ years of industry experience
- Knowledge of FDA and ICH guidelines