Director of Clinical Writing
Title: Associate Director or Director of Clinical Writing
Reports to: VP of Acumen
Overview:
Excellent opportunity to join a fast-growing medical writing and clinical development organization. Acumen was started in 2016 by experienced writers and MDs from within industry, with the goal of creating the highest quality medical writing and clinical development support for innovative companies in biotech. The Director of Clinical Writing is a Senior Management position which will collaborate with a team of experienced and high-functioning leaders with the goal of continuing to build a top-tier organization. The ideal candidate will combine a strong background in clinical development with strong interpersonal skills, and top-level data analysis and writing skills. Working knowledge of various aspects of clinical development is crucial. This is position will initially include a significant amount of direct writing, with increasing oversight and management of other writers over time.
Compensation:
Base salary: $180,000, depending upon experience
Profit share
Health and Dental Insurance
401K match
Responsibilities:
Lead the development of various regulatory documents and publications for Acumen’s clients
Mentor and train junior clinical medical writers to ensure Acumen delivers best-in-class medical writing services
Help build Acumen’s medical writing infrastructure, including development and refinement of standard writing procedures and best practices
Work collaboratively with the Acumen Senior Management on all aspects of business development
Growth opportunity to directly manage in-house writers and oversee assigned Acumen-Client relationships, including management of resources and budgets
Requirements:
7+ years working as a clinical writer directly for a drug-developer or CRO supporting drug-development
Experience leading all aspects of the following documents:
Clinical study protocols, clinical study reports, investigator brochures, type B and C briefing books and other regulatory correspondences
Experience leading key components of an NDA or BLA submission
Strong interpersonal skills, including written and oral communication
Deep knowledge of the current regulatory landscape
Independent and self-motivated
Eager to help build a young CRO into a world-class organization
Experience or interest in publication writing a plus
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