Associate Director, US Commercial Regulatory Affairs - Advertising and Promotion

Associate Director, US Commercial Regulatory Affairs - Advertising and Promotion (Hybrid)

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The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for an assigned product/therapeutic area in order to help ensure the Company's objectives are met. Individual will ensure materials are consistent with BMS guiding principles, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidances.

Responsibilities

• Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area
• Provides solution-oriented and innovative advice to meet the company's objectives and goals
• Provide strategic advice for the development of Advertising and Promotional Labeling Branch (APLB) and Office Of Prescription Drug Promotion (OPDP) advisory submissions and subpart E and H submissions
• Ensure full regulatory compliance of all promotions with approved labeling and /or FDA guidances
• Ensure regulatory compliance with subpart E/H and 2253 regulations
• Lead training for Commercial teams on subpart E/H, 2253 regulations and FDA regulations on advertising and promotion
• Ensure monitoring and maintenance of knowledge of the evolving regulatory landscape to provide innovative solutions and advice
• Pursues and understands diverse perspectives inside and outside BMS to provide risk assessment and mitigation strategies
• Develop and maintain strong working relationships with internal customers, including Commercial, Medical, Public Affairs, Legal and Compliance
• Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues
• Provide advice and guidance as appropriate on the development of draft product labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based
• Provide input on process improvement and BMS guiding principles as needed
• Engages with colleagues within the department to help support them in their roles and development
• Provide direct management to individuals depending on assignment
• Proactively seeks opportunities to learn and develop leadership skills

Qualifications

• BS required; advanced degree preferred (MS, PhD, PharmD, JD)
• Minimum of 3-5 years Regulatory promotional review or related 5 to 8 years pharmaceutical experience (e.g., Medical promotional review)
• Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products and strong interest in FDA advertising and promotion regulations including guidance(s)
• Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns
• Proven aptitude to analyze and interpret efficacy and safety data
• Experience communicating and negotiating with OPDP/APLB
• Organizational skills and ability to pay attention to details. Demonstrated ability to negotiate and influence others to help build team collaboration
• Excellent verbal, communication, and presentation skills
• Excellent interpersonal skills, flexibility, adaptable to a changing environment and adeptness to communicate effectively with cross functional teams and with business partners across the company.

Compensation Overview

Madison - Giralda - NJ - US $173,350 - $210,058
Princeton - NJ - US $173,350 - $210,058

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 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 including 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.

Occupancy Structure

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.

Supporting People With Disabilities

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 . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at .

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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