100% Remote Opportunity
Summary: The Associate Director of Medical Writing will serve as the medical writing lead for the preparation of a variety of clinical documents, including but not limited to CSRs, Investigator's Brochures, and protocols, for regulatory/clinical purposes. You will also oversee and manage medical writing vendors, contract staff and/or junior medical writers as well as coordinate the efforts of cross-functional teams in order to produce high quality, scientifically accurate documents. If you are a medical writer looking to work at a leading gene therapy biotechnology company, please see below.
The Associate Director, Medical Writing will be responsible for:
- Serving as principal writer for and coordinating development of clinical protocols/amendments, clinical study reports (CSRs), investigator's brochures, Module 2 summaries, as well as any other regulatory submissions as needed, in addition to abstracts, posters and manuscripts
- Leading and/or organizing document review and development meetings
- Ensuring adherence to clinical/regulatory timelines, standards, and processes, as well as developing them
- Guiding medical writing and cross-functional initiatives relating to processes, template development and document standards
- Performing literature searches ad research pertaining to writing activities
- Reviewing statistical analysis plans to ensure alignment with anticipated data presentations in CSRs and Module 2 summaries
The Associate Director, Medical Writing should have the following qualifications:
- A Bachelor's, Master's, PharmD or Ph.D. in a life sciences or related field
- A minimum of 4 years' pharmaceutical and/or biotechnology industry experience within the clinical/regulatory medical writing space
- Knowledge of ICH guidelines, GxP, and other relevant regulatory requirements
- Experience independently authoring standard clinical document types, including but not limited to CSRs, investigator's brochures and protocols
If you interested in the Associate Director, Medical Writing position, then don't wait to apply!