Neurocrine Biosciences is hiring: Medical Writing Manager/Sr. Medical Writing Ma

Overview

Who We Are: At Neurocrine Biosciences, we pride ourselves on a strong, inclusive, and positive culture based on our shared purpose and values. We are passionate about people and our mission to relieve suffering for people with great needs.

What We Do: Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. Our portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, congenital adrenal hyperplasia, endometriosis and uterine fibroids, with a robust pipeline in mid- to late-phase development. For three decades we have pursued medicines to ease the burden of debilitating diseases. For more information, visit neurocrine.com and follow us on LinkedIn, X, and Facebook.

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 compliant with internal and external standards. Medical Writing activities include leading the authoring process, identifying and managing contractors, planning NDAs and global MAAs, and building the submission writing team with in-house and contract resources. The ideal candidate will live in or be able to relocate to San Diego; relocation support is offered.

Your Contributions (include, but are 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, responses 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 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 practices and provides continuous training to teams.
• Mentors internal staff.
• Represents Medical Writing on departmental projects and cross-functional teams.
• Assists other writers on NDAs and MAAs.
• Proven leader who is confident, open to new ideas, and exemplifies the Neurocrine culture of collegiality and teamwork.
• Other duties as assigned.

Requirements

• BS/BA in life sciences or related field with 8+ years of medical writing or related experience; experience leading an NDA/MAA or authoring key documents (e.g., Summary of Clinical Efficacy, Summary of Clinical Safety, Clinical Overview) is highly preferred OR
• Master’s degree in life sciences or related field with 6+ years of relevant experience OR
• PhD in life sciences or related field with 4+ years of relevant experience.
• Ability to interpret and present scientific and clinical trial data, and understand statistical analyses.
• Strong scientific background enabling interpretation and communication of data.
• Broad understanding of medical writing processes, procedures, and systems (e.g., DMS).
• Ability to provide constructive feedback on communicating and positioning nonclinical and clinical data.
• Excellent understanding of writing and regulatory processes to streamline content and processes.
• Experience leading NDA/MAA or authoring key documents as noted above.
• Anticipates business and industry issues; recommends relevant process or technical improvements.
• Demonstrates broad expertise or unique knowledge; applies it to improve team efficiency.
• Ability to lead multiple teams and mentor lower levels staff and/or indirect teams.
• Excellent computer skills and Microsoft Word/PowerPoint proficiency, document management systems, and electronic review tools.
• Excellent communications, problem-solving, and analytical thinking skills.
• Ability to meet multiple deadlines with high accuracy across projects/programs.
• Proven ability to lead cross-functional teams through the authoring process.
• Excellent team player who can navigate differing opinions and work well independently and as part of a team.
• Excellent project management skills, including managing simultaneous projects.
• Strong understanding of the broader impact on division/company.

Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we encourage applications from candidates whose experience or qualifications may not line up exactly with the job description.

The annual base salary we reasonably expect to pay is $153,800.00-$222,850.00. Individual pay decisions depend on factors such as primary work location, role complexity, and relevant experience. This position offers an annual bonus with a target of 30% of base salary and eligibility for our equity-based long-term incentive program. Benefits include retirement savings with company match, paid vacation/holiday/personal days, caregiver/Parental and medical leave, and health benefits (medical, prescription drug, dental, and vision) per plan terms.