Barrington James
Senior Director / Director Medical Writing
Barrington James, New York, New York, United States,
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.
QualificationsMS, PharmD, PhD is requiredMinimum of 10 years of relevant clinical and regulatory writing experienceMinimum of 5 years of management experienceRegulatory applications (IND, NDA/BLA) experience is a mustunderstanding of statistical concepts and techniques including understanding of scientific content with the ability to interpret into final submission-ready documentsFamiliar 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 sfridi@barringtonjames.com
The Ideal candidate will be located on the West Coast as this is an onsite position.
QualificationsMS, PharmD, PhD is requiredMinimum of 10 years of relevant clinical and regulatory writing experienceMinimum of 5 years of management experienceRegulatory applications (IND, NDA/BLA) experience is a mustunderstanding of statistical concepts and techniques including understanding of scientific content with the ability to interpret into final submission-ready documentsFamiliar 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 sfridi@barringtonjames.com