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]