Associate Director of Medical Writing

RBW has partnered with an exciting, growing biotech client to find their next Associate Director of Medical Writing / Principal Medical Writer. This position is REMOTE for US-based candidates.

This opportunity will call for you to take charge of and effectively lead the strategic direction for the company’s first-ever upcoming NDA submission, with a goal of submission by the end of 2022.

You will also contribute to the planning, writing, reviewing, and finalizing of protocols and protocol amendments, clinical study reports (CSRs), Investigator’s Brochures (IBs) and updates, as well as INDs, NDA/BLA/MAA summary sections, regulatory agency briefing documents, and regulatory agency responses. Vendor oversight experience is desirable but not required.

This opportunity comes with a very competitive salary, an annual bonus, comprehensive benefits, equity in the company, and additional perks and career growth opportunities.

Candidates with at least 5 years of medical writing experience in the pharmaceutical, biotech, or CRO space will be considered first. Candidates should have experience contributing to or leading an NDA submission process.

If this position is not a strong match for what you are looking for, please feel free to reach out to me directly at chris.dart@rbwconsulting.com to discuss the many other opportunities I have in the Medical Writing space.