Sr. Medical Writing Manager

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 leading 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, neuroendocrine, and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, 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, visitneurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

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• Leads 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, PIPs and PSPs, and other regulatory documents as appropriate

• Leads multi-disciplinary teams and provides subject matter expertise to the core authoring team (Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics, Drug Safety and Pharmacovigilence, nonclinical, Clinical Pharmacology and Regulatory) from a writing and scientific perspective

• Interprets and presents scientific data, leads comment resolution meetings

• Ensures document content is clear, concise, strategic, and well positioned for public disclosure

• Leads and implements best authoring best practices and provides continuous training to teams

• Mentor internal staff

• Represent Medical Writing on departmental projects and cross-functional teams

• Assist other writers on NDAs and MAAs

• Proven leader who is confident, open to new and opposing ideas, and an exemplifies the Neurocrine culture of collegiality and teamwork

• Other duties as assigned

• 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

• Strong science background that enables the ability to interpret and communicate scientific and clinical trial data

• Broad understanding of the medical writing processes, procedures, and systems (eg DMS)

• 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 leading NDA/MAA or authoring key documents supportive of either (e.g., Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overview, etc.)

• Anticipates business and industry issues; recommends relevant process / technical / service improvements

• Demonstrates broad expertise or unique knowledge

• Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team

• Ability to work as part of and lead multiple teams

• Mentoring skills and ability to leads lower levels staff and/or indirect teams

• Excellent computer skills

• Excellent communications, problem-solving, analytical thinking skills

• Recognizes broader picture and longer-term impact on division/company

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

• Proven ability to lead cross-functional teams through the authoring process

• Excellent team player who can effectively navigate differing opinions and personalities

• Able to work well both independently and as part of a team

• Excellent project management skills, including managing simultaneous projects

• Excellent understanding of Microsoft Word and Powerpoint, document management systems, and electronic review tools

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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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