Senior Manager, Medical Editing

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

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 listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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