Principal/Associate Director of Medical Writing

Discipline: Clinical Research
Job type: Permanent
Contact name: Chris Dart

Contact email:
Contact phone: +1 617 982 1238
Job ref: 20865
Published: 19 days ago
Expiry date: 15 August 2021

I am partnering with an innovative and exciting biotech client of mine to find their next Principal/Associate Director of Medical Writing to join their team. This position is a REMOTE opportunity for US-based candidates.

This position will provide you with the opportunity to build out the Medical Writing function within a growing and dynamic company. Sitting underneath a fantastic leadership team, you will work cross-functionally with the company’s internal teams to ensure the planning, execution, and delivery of all clinical and regulatory documents for the program.

You will contribute to planning, writing, reviewing, and finalizing protocols and protocol amendments, clinical study reports (CSRs), Investigator’s Brochures (IBs) and updates, as well as NDA/BLA/MAA summary sections, regulatory agency briefing documents, and regulatory agency responses. With multiple trials currently ongoing at various stages of development, and more plans for growth in the future, you will be able contribute to a variety of unique studies to further broaden your therapeutic experience.

As the Principal/Associate Director, you will also operate as the leader of the Medical Writing function within the organization. In addition to planning and contributing to the execution of crucial documents, you will also be empowered to develop and implement a growth plan for the Medical Writing department.

This opportunity comes with an industry leading salary, annual bonus, comprehensive benefits, equity in the company, and an unbelievable opportunity to take complete ownership over the Medical Writing function of the company.

This is a fully REMOTE opportunity with very limited travel expected.

The ideal candidate will have 5+ years of experience as a medical writer in the pharmaceutical or biotech space, and previous experience authoring successful global clinical and regulatory documents.