Senior Director / Director Medical Writing
Currently partnered with a exciting specialist Biotech - Seeking a Sr Director / Director Medical Writing. The company had very positive data readouts late last year, with a Biologics focused pipeline.
The Ideal candidate will be located on the West Coast as this is an onsite position.
Qualifications
- MS, PharmD, PhD is required
- Minimum of 10 years of relevant clinical and regulatory writing experience
- Minimum of 5 years of management experience
- Regulatory applications (IND, NDA / BLA) experience is a must
- understanding of statistical concepts and techniques including understanding of scientific content with the ability to interpret into final submission-ready documents
- Familiar with eCTD structure, and experience with eCTD summary documents (e.g. Modules 2.5 and 2.7) and / or regulatory briefing document, ensuring accuracy, consistency, and compliance with regulatory guidelines (e.g., FDA, EMA, ICH).
If your interested please apply directly or use my direct email [email protected]
Senior Director / Director Medical Writing
Currently partnered with a exciting specialist Biotech - Seeking a Sr Director / Director Medical Writing. Minimum of 10 years of relevant clinical and regulatory writing experience. ...
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