Senior Manager, Medical Writing

🕒 May 17

🏄 California – Remote

🏄 California – Remote

💵 $154.5k - $211k / year

⏰ Full Time

🟠 Senior

✏️ Content Writer

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Neurocrine Biosciences

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

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.

📋 Description

• Prepares and reviews clinical/regulatory documents to support all phases of drug development • Leading the writing activities for all regulatory documents for a project team • Identifying and managing contractors • Planning activities for New Drug Applications (NDAs) and global Marketing Authorization Applications (MAAs) • Building and managing the submission writing team • Authors and manages the authoring process for all clinical/regulatory documents • Leads and provides subject matter expertise to the core authoring team • Ensures document content is clear, concise, strategic, and well positioned for public disclosure • Supports authoring best practices and provides continued training to teams • Represents Medical Writing Department on project teams • Mentor and may manage internal staff

🎯 Requirements

• BS/BA degree in the 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 • MS/MA degree in a life sciences or related field preferred AND 6+ years of experience as noted above • PhD in a life sciences or related field preferred AND 4+ years of experience as noted above • Previous managerial / functional management experience also required • Excellent team player who can effectively navigate differing opinions and personalities • Strong skills in leadership, communication and creativity • Excellent project management skills, including managing simultaneous projects • Excellent understanding of Microsoft Word and Powerpoint, document management systems, and electronic review tools • General understanding of statistics • Broad understanding of the medical writing processes, procedures, and systems

🏖️ Benefits

• Retirement savings plan (with company match) • Paid vacation • Holiday and personal days • Paid caregiver/parental and medical leave • Health benefits including medical, prescription drug, dental and vision coverage