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Director, Medical Writing

Company: Neurocrine Biosciences
Location: San Diego
Posted on: October 13, 2019

Job Description:

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 disorders.

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 templates.

_

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 guidance.

* 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 deliverable timelines.

* Works closely with functional leadership and cross-functional project teams to ensure effective document prioritization and development.

* 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.

REQUIREMENTS:

* 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 important.

* 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 resources.

* 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.

Keywords: Neurocrine Biosciences, San Diego , Director, Medical Writing, Advertising , San Diego, California

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