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Director, Medical Writing
San Francisco , CA 94102
Posted 2 months ago
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We are developing prescription software for treating and reversing metabolic diseases, like diabetes and heart disease. We believe software is on the verge of disrupting medicine and becoming the accepted standard of care for treating diseases caused by behaviors. We have validated our software through multiple clinical trials and are beginning to commercialize with private health insurance, while pursuing FDA approval to our first indicated use.
Our founding team has started, led and exited multiple technology companies that have transformed industries and generated billions of dollars in enterprise value. The 17th Surgeon General of the US, Dr. Richard Carmona, serves as an independent board director.
We were founded in 2015; are headquartered in San Francisco, with operations in Boston, MA, and Nashville, TN.
ABOUT THE ROLE
The Director, Medical Writing will be responsible for leading and managing all efforts in writing, revising and coordinating regulatory documents, peer-reviewed scientific publications, clinical protocols and training materials for clinician and non-clinician members of our Care Team.
You will report to the Head of Health, an internist, and will work closely with clinical researchers, scientific and regulatory advisors, and our Product and Care Teams. This is a contract position, and you can be located anywhere (West Coast preferred).
- You will own and be accountable for every element of medical writing that, with incorporation of our teams current clinical outcomes and intellectual assets, will lead to successful publications.
- You will use play a pivotal role in translating a diverse set of medical concepts and data into a cohesive and compelling argument for our work.
- You will ensure that medical content is clearly understood by the audience, be it FDA or IRB reviewers, external medical peers, health coaches or business partners without medical training.
- You will elevate the ability of the team to transform complex into simple, so that the language we use to describe our work permeates throughout our organization and our efforts to develop prescribable therapeutics are accelerated.
- You are an astute communicator, that doesnt need excess words or jargon to make a point.
- You have at least a BS (MS or Ph.D., preferred) in a scientific or medical field.
- You have a minimum of 5 years of clinical and regulatory writing experience in metabolic diseases, and 10 years experience managing medical writing within the biotechnology/pharmaceutical industry.
- Youre knowledgeable about FDA guidelines, IRB, CRO and journal manuscript submission processes and have contributed to published manuscripts, protocols (Phase 3 preferred) and regulatory submissions.
- You are skilled at collaborating with cross-functional teams to produce high quality work and can comfortably switch between collaborative writing and reference platforms (e.g., MS Word, Google docs, Zotero) to achieve timely deliverables.
- You can distill large amounts of clinical and scientific data into impactful manuscripts and abstracts.
- You have an interest in lifestyle medicine, neuroscience, or behavioral psychology.
- Youre familiar with or have experience working with early stage companies.