Director, Medical Writing
Company: Neurocrine Biosciences
Location: San Diego
Posted on: October 13, 2019
WHO WE ARE:
At Neurocrine Biosciences - voted one of San Diego's top places to
work in 2018 - we pride ourselves on having a strong, distinctive
and positive culture based on our shared purpose and values. We
know what it takes to be great, and we are as passionate about our
people as we are about our purpose - to relieve patient suffering
and enhance lives.
WHAT WE DO:
Neurocrine Biosciences is a biopharmaceutical company focused on
developing treatments for neurological and endocrine related
ABOUT THE ROLE:
The Director, Medical Writing, will prepare and review
clinical/regulatory documents to support all phases of clinical
drug development. The position will work closely with an
interdisciplinary team to ensure documents are of high quality and
comply with internal and external standards. This position will
also assist in the development of internal standards and
YOUR CONTRIBUTIONS (INCLUDE, BUT ARE NOT LIMITED TO):
* Acts as the subject matter expert for clinical regulatory
document preparation across multiple therapeutic areas in
compliance with ICH, FDA, EMA and/or PMDA standards and
* Responsible for all phases of clinical document preparation,
review, revision, finalization and approval of regulatory
documents. Documents include, but are not limited to, clinical
protocols, clinical study reports, investigator brochures, and
sections of global submission documents (IND/CTAs, NDAs, MAAs)
which may include briefing documents, ad hoc requests.
* Manages medical writing projects, including timelines. Works with
project teams and functional management to appropriately manage
* Works closely with functional leadership and cross-functional
project teams to ensure effective document prioritization and
* Works closely with subject matter experts to identify key product
attributes, messages and confidently interprets complex scientific
and medical data.
* May supervise, and provide guidance and feedback on documents
prepared by independent consultants.
* BS, MS or PhD degree and at least 7 years relevant work
experience or equivalent education and experience.
* Must have a successful track record of contributions to IND/CTA
and NDA/MAA document preparation, preferably in the neurology and
psychiatry therapeutic areas.
* The ability to thrive in a dynamic, growing environment is
* Experience from working on small and large molecules, plus gene
therapies would be an advantage but is not a pre-requisite.
* Medical writing experience to support international clinical
development and regulatory submissions is a distinct advantage.
* Strong scientific written and oral communication skills.
* Commitment to detail, and ability to effectively prioritize while
working on multiple programs and projects.
* Ability to clearly communicate and understand complex clinical
and scientific concepts across therapeutic areas is essential.
* Ability to meet deadlines using both internal and external
* Demonstrates strong problem solving and analytical abilities.
* Possesses exceptional communication skills, creativity,
interpersonal skills, and the ability to effectively manage and
implement multiple projects.
Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.
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