Senior Manager, Commercial Regulatory Affairs - Advertising & Promotion

Bristol Myers Squibb•Madison, WI

1d•Hybrid

About The Position

The primary responsibility of a Senior Manager in 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’s.

Requirements

Minimum education of a bachelor's degree is required.
Minimum of five (5) years of broad “hands on” related pharmaceutical experience and FDA regulatory experience is required.
Minimum of at least one (1) year of regulatory promotional review experience is required.
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).
Detail & deadline oriented; well organized.
Excellent verbal and written communication skills.
Good interpersonal skills; ability to interact with staff on all levels.

Nice To Haves

Life science area of study or advanced degree preferred (MS, PhD, PharmD, or JD).

Responsibilities

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 and FDA guidance.
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 APLB.
Prepare communications with guidance for APLB concerning Subpart E and advisory submissions.
Ensure timely and accurate submission of promotional materials to APLB on Form 2253.
Participate in review of product labeling submissions.
Works with management to ensure that changes in USPI are reflected in current promotions and advertising.
Handle other duties and/or special projects as assigned

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Flexible time off (unlimited, with manager approval)
11 paid national holidays
160 hours annual paid vacation for new hires with manager approval
11 national holidays
3 optional holidays
Unlimited paid sick time
up to 2 paid volunteer days per year
summer hours flexibility
leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
an annual Global Shutdown between Christmas and New Years Day.