Job Description

Overview

Associate Director, Commercial Regulatory Affairs- Advertising and Promotion at Bristol Myers Squibb seeks an experienced regulatory professional to advise on promotional materials and campaigns for an assigned product/therapeutic area, ensuring compliance 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 Office Of Prescription Drug Promotion advisory submissions and sub part e submissions
• Ensure full regulatory compliance of all promotions with approved labeling and /or FDA guidances
• Ensure regulatory compliance with sub part e and 2253 regulations
• Lead training for Commercial teams on sub part e, 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
• 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 and Benefits

The starting compensation for this job is a range from $173,350 - $210,100, plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

Final, individual compensation will be decided based on demonstrated experience.

Benefits

• 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 Years holiday, up to 120 hours of paid vacation, up to two 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

On-site and Work Model

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.

Job Details

• Seniority level: Director
• Employment type: Full-time
• Job function: Legal
• Industries: Pharmaceutical Manufacturing

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