Sr. Manager, Medical Writing

Sr. Manager, Medical Writing page is loaded## Sr. Manager, Medical Writing remote type:
On-Site locations:
US CA San Diegotime type:
Full time posted on:
Posted Todayjob requisition :
R6455##

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, 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 suffering for people with great needs.##

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis  and uterine fibroids,  as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas.

For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit , and follow the company on ,  and . (
* in collaboration with Abb Vie*)##

About the Role:

Prepares and reviews clinical/regulatory documents to support all phases of drug development by leading the writing activities of an interdisciplinary team to develop documents that are concise, high quality, and comply with internal and external standards. Lead the writing activities for all regulatory documents for a project team, which include leading the writing process, identifying and managing contractors, planning activities for New Drug Applications (NDAs) and global Marketing Authorization Applications (MAAs), and building and managing the submission writing team.

This role is onsite at our beautiful campus in San Diego, CA, we offer relocation support for those not local. ## Your Contributions (include, but are not limited to):
* Authors and manages the authoring process for all clinical/regulatory documents (eg, clinical study protocols, clinical study reports, investigator brochures, briefing documents, M2 Clinical Summary Documents for INDs, NDAs, MAAs, annual safety update reports, response to regulatory questions, Pediatric Investigational Plans, and other regulatory documents)
* Leads and provides subject matter expertise to the core authoring team (Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics, Drug Safety and Pharmacovigilence, Preclinical, and Regulatory) from a writing and scientific perspective
* Leads data interpretation and comment resolution meetings
* Ensures document content is clear, concise, strategic, and well positioned for public disclosure
* Supports authoring best practices and provides continued training to teams
* Represents Medical Writing Department on project teams
* Mentor, and may manage, internal staff
* Represent Medical Writing on departmental projects and cross-functional teams
* Supports other lead writers on NDAs and MAAs
* Other duties as assigned## Requirements:
* BS/BA degree in the life sciences or related field AND 8+ years of medical writing or related experience required. Experience leading an NDA/MAA or authoring key documents supportive of either (e.g., Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overview, etc) is highly preferred. OR
* MS/MA degree in a life sciences or related field preferred AND 6+ years of experience as noted above OR
* PhD in a life sciences or related field preferred AND 4+ years of of experience as noted above OR
* Previous managerial / functional management experience also required
* Proven ability to lead cross-functional teams through the authoring process
* Excellent team player who can effectively navigate differing opinions…