RBW has partnered with a very exciting mid-sized biotech based in the Bay Area in part of their search for an AD of Medical Writing (Regulatory).
This person will provide medical writing expertise to prepare quality clinical regulatory documents for Health Authority submissions. You will be heavily involved in planning, editing, formatting, and finalizing regulatory documents (IND/CTA, Protocols, CSRs, IBs, briefing books) as well as leading document review and comment resolution meetings.
If you have the following expertise, we encourage you to apply:
- MS or PhD in a scientific field preferred
- 9+ years of experience in regulatory medical writing within a biotech or pharmaceutical company
- Submission experience to the FDA (IND, BLA) and EMA (MAA)
Must be US Citizen or Green Card Holder
