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 neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)
About the Role:
Prepares and reviews clinical/regulatory documents that are high quality, concise, and comply with internal and external standards in support of all phases of drug development. Participates as subject matter expert for Medical Writing on product teams, leads the authoring process, works with contractors, and participates in timeline development for documents and New Drug Applications (NDAs) and global Marketing Authorization Applications (MAAs)._
Your Contributions (include, but are not limited to):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
Requirements:BS/BA degree in life sciences or related field and 6+ 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 4+ years of similar experience noted above OR
PhD in life sciences or related field and 2+ 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/Disability/Vets employer.
We are committed to building a workplace of belonging, respect, and empowerment, 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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The annual base salary we reasonably expect to pay is $128,200.00-$185,900.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.