Sr. Medical Writing Manager

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, but few options.What We Do: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.About the Role:Prepares and reviews clinical/regulatory documents to support all phases of drug development by leading the writing activities of a multi-disciplinary team to develop documents that are concise, high quality, and comply with internal and external standards. Medical Writing activities include leading the authoring process, identifying and managing contractors, planning New Drug Applications (NDAs) and global Marketing Authorization Applications (MAAs), and building the submission writing team with in-house and contract resources.Your Contributions (include, but not limited to):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 Pharmacovigilance, nonclinical, Clinical Pharmacology and Regulatory) from a writing and scientific perspectiveInterprets and presents scientific data, leads comment resolution meetingsEnsures document content is clear, concise, strategic, and well positioned for public disclosureLeads and implements best authoring best practices and provides continuous training to teamsMentor internal staffRepresent Medical Writing on departmental projects and cross-functional teamsAssist other writers on NDAs and MAAsProven leader who is confident, open to new and opposing ideas, and exemplifies the Neurocrine culture of collegiality and teamworkOther duties as assignedRequirements: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 ORMaster's degree in life sciences or related field and 6+ years of similar experience noted above ORPhD in life sciences or related field and 4+ years of similar experience noted aboveAbility to interpret and present scientific and clinical trial data, as well as understand statistical analysesStrong science background that enables the ability to interpret and communicate scientific and clinical trial dataBroad 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 dataExcellent understanding of the writing and regulatory process that enables streamlining of content and processesExperience 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 improvementsDemonstrates broad expertise or unique knowledgeApplies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of teamAbility to work as part of and lead multiple teamsMentoring skills and ability to lead lower levels staff and/or indirect teamsExcellent computer skillsExcellent communications, problem-solving, analytical thinking skillsRecognizes broader picture and longer-term impact on division/companyAbility 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 processExcellent team player who can effectively navigate differing opinions and personalitiesAble to work well both independently and as part of a teamExcellent project management skills, including managing simultaneous projectsExcellent understanding of Microsoft Word and PowerPoint, document management systems, and electronic review toolsNeurocrine 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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