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, but few options.

Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple 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. *in collaboration with AbbVie

About the Role:

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• Leads the authoring process for a variety of clinical/regulatory documents (eg, clinical study protocols; clinical study reports; investigator brochures; briefing documents; M2 Clinical Summary Documents for INDs, NDAs, and MAAs, PIPs, PSPs; response to regulatory questions; and other regulatory documents as appropriate.

• Ability to independently interpret and communicate scientific data.

• Represents Medical Writing on project teams and provides subject matter expertise to the core authoring team (Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics, Drug Safety and Pharmacovigilence, Nonclinical, and Regulatory) from a writing and scientific perspective

• Interprets scientific data and interacts with functional leads in data interpretation and positioning in documents.

• Leads comment resolution meetings

• Ensures documents are clear, concise, strategic, and well positioned for public disclosure

• Researches, recommends, and participates as a key contributor for implementing best authoring best practices and provides continuous training to teams

• May train / lead lower level staff

• Assist other writers on NDAs and MAAs

• Other duties as assigned

• Working remotely could be an option

• BS/BA degree in 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

• Master's degree in life sciences or related field and 6+ years of similar experience noted above, OR

• PhD in life sciences or related field and 4+ years of similar experience noted above

• Ability to interpret and present scientific and clinical trial data, as well as understand statistical analyses.

• Ability to communicate data in a manner that is accurate and provides the appropriate understanding of the benefit/risk of a product.

• Proven ability to lead teams through the authoring process

• Ability to provide constructive feedback as it relates to communicating and positioning nonclinical and clinical data.

• Excellent understanding of the writing and regulatory process that enables streamlining of content and processes

• Experience working with and leading contract medical writers

• Experience with NDA/MAAs or authoring key documents supportive of either (e.g., Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overview, etc.) is preferred.

• Ability to independently (with minimal supervision) understand, interpret, and communicate scientific data

• Understands the drug development process

• Exhibits leadership through supporting and leading writing best practices with cross-functional teams.

• Strong understanding of the medical writing process, procedures, regulatory requirements, and systems (eg., DMS)

• Ability to meet multiple deadlines across a variety of projects, with a high degree of accuracy and efficiency.

• Excellent communications, problem-solving, analytical thinking skills.

• Ability to be a supportive, effective, and valued team member

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Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.

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