Associate Director Commercial Regulatory Affairs

Profile

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

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 include:

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 areaProvides 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.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Company: Bristol-Myers Squibb

Req Number: R1528040_EN

Updated: 2020-07-27 00:00:00.000 UTC

Location: Princeton,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com