Senior Manager, Advertising and Promotion, Commercial Regulatory Affairs (R1537616-en-us)
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 primary responsibility of the Senior Manager, Advertising and Promotion, Commercial Regulatory Affairs is to provide expert and strategic regulatory advice and risk assessment on promotional issues with guidance from management to ensure that BMS implements product promotion consistent with BMS policies, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidance documents
Provide regulatory advice and risk assessment on concepts and final advertising/promotional materials, sales training materials, and external communications for marketed products, as assigned.
Assure full regulatory compliance of all promotions with approved labeling, FDA guidance documents, and OPDP advisory comments.
Maintain up-to-date knowledge of laws, regulations and policies enforced by the Federal and State governments as they relate to advertising and promotion of pharmaceuticals.
Build a strong relationship with internal customers; including Commercial, Legal and Medical.
Begin to develop relationships with OPDP.
Prepare communications with guidance for OPDP concerning sub part e and advisory submissions.
Ensure timely and accurate submission of promotional materials to OPDP on Form 2253.
Participate in review of product labeling submissions.
Works with management to ensure that changes in US PI are reflected in current promotions and advertising.
Handle other duties and/or special projects as assigned
Bachelors Life Science degree required; advanced degree preferred (MS, PhD, PharmD, or JD).
Candidate should have a minimum of 1-2 years Regulatory promotional review experience.
Candidate should have experience providing strategic direction to interdisciplinary teams on promotional materials activities for marketed products and strong interest in FDA advertising and promotional practice regulations including guidance(s).
Broad “hands on” related pharmaceutical experience (prefer 5 years pharmaceutical industry experience) or actual FDA regulatory experience.
Detail & deadline oriented; well organized.
Excellent verbal and written communication skills.
Good interpersonal skills; ability to interact with staff on all levels.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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