I am working with a clinical-stage biopharmaceutical company that develops innovative therapies for patients with autoimmune diseases. They are looking to expand their team by taking on a Sr. Director of Medical Writing to support all phases of drug development through writing activities. Please see the responsibilities and requirements below:
This position is based out of New York City, but being offered as full-time permanent, 100% remote.
- Writing, reviewing, editing and finalization of protocols, IBs and IB updates, CSRs and summary modules for Regulatory submissions, briefing documents and regulatory agency responses
- Managing and driving timelines for documents and ensuring they are quality checked
- Collaborate with the Head of Medical Communications for clinical and regulatory documents
- Authoring NDA/BLA/MAA summary sections
- Minimum 12 years of medical writing in pharma/biotech with a Master of Science degree
- Strong communication and interpersonal skills with cross-functional teams
- Independently interpret clinical data, statistical methods, and analysis plans
- Knowledge of electronic document formats and document management systems
If you are looking for similar opportunities or know of anyone in your network looking for a position, please reach out to learn more!