Senior Manager, Medical Editing

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Summary:

The Senior Manager, U.S. Label & Launch Operations, Medical Editing, is responsible for managing the operational processes associated with FDA subpart submissions in the U.S. market. This role will define, drive, and execute the subpart E/H submissions across therapeutic areas to ensure compliance with all FDA guidelines and is responsible for overseeing coherence across tactics of all brands.

The role works closely with the Brand Teams, Commercial Regulatory Affairs, Worldwide Commercializa0on Excellence (WCE) and the cross-func0onal teams on strategy and execution of all subpart submissions across various channels while providing compliance oversight.

This is an important role within U.S. Commercialization Strategy & Operations Organization and key to Bristol Myers Squibb’s ambition to continue advancing the efficient and expeditious execution of subpart submissions strategy and operations. In this position, this individual will report directly to the Associate Director, U.S. Label & Launch Operations.

Responsibilities:

• Manage a growing team of medical editors, including contingent workers, ensuring workload distribution and quality control
• Oversee the creation of annotated reference packs for promo0onal materials, ensuring they meet FDA standards and are formaWed for electronic submission (eCTD)
• Develop annotated reference packs for promotional materials, ensuring they meet FDA standards by adding reference annotations to PDFs – highlight and back annotate corresponding references – for FDA submission
• Provide compliance oversight and ensure all materials are free from errors and up to standard
• Collaborate with matrices teams to create strategy for mul0-project submissions and oversee the day to-day project management
• Assist in the documentation, maintenance, and improvement of SOPs and training programs for internal teams and external agencies
• Drive initiatives to streamline workflows and improve submission accuracy and efficiency
• Provide mentorship and technical guidance to junior medical editors, fostering expertise in FDA submission standards and editorial best prac0ces
• AWend meetings with regulatory, legal, and marke0ng stakeholders to align on timelines and project scope
• Lead kickoff meetings for major submissions and ensure alignment on deliverables and timelines
• Contribute to broader operational strategies, including launch planning and label updates
• Translate complex medical information into patient-friendly language
• Assist in the proofreading of package inserts, medication guides, brief summaries, and other labeling documents

Qualifications:

• Bachelor’s Degree or equivalent
• Experienced leader with minimum 3 years’ experience managing teams
• Minimum of 5 years of experience in FDA reference pack creation
• Expert in Adobe Acrobat Professional
• Thorough understanding of pharmaceutical LMR review process
• Expert in the review and editing of regulatory documents for clarity, consistency, and compliance with FDA and internal standards
• Expert in FDA Guidelines for Subpart E/H Submissions
• Knowledge of medical/pharmaceutical terminology and federal regulations governing pharmaceutical advertising

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview:

Field - United States - US: $126,990 - $153,882

The starting compensation range(s) for this role are lis