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Bristol Myers Squibb CAR T/Hematology- Director Commercial Regulatory Affairs in Summit, New Jersey

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.

Description: The Director of US Commercial Affairs for CAR T/Hematology requires the ability to apply integral and complex scientific data and strategic regulatory advice to advertising and promotional materials in order to help the Company meet business objectives. The Director is also responsible for leading a team of regulatory professionals that provides consistent and expert regulatory advice and guidance. Director will ensure compliance with BMS guiding principles, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidances.

Responsibilities include:

  • Director will report to the Senior Director for Hematology/ CAR T with specific responsibility of managing the overall CAR T franchise, direct report(s) and reviewing promotional materials for one of the CAR T products.

  • Provides strategic advice, guidance, and risk assessment for effective promotional materials across area of responsibility to help ensure business goals and objectives are met

  • Ability to identify problems and work to provide solution oriented, innovative advice that takes into consideration previous decisions made across the Company

  • Provides direct management of individual(s) including:

  • Mentoring and coaching

  • Career development plans

  • Ensuring accountability

  • Ensures understanding of the promotional review process and the principles of decision making and helps to foster a collaborative environment

  • Encourages an environment of innovation, change, and models the department vision and mission, including BMS Core Values

  • Assure full regulatory compliance of all promotions with approved labeling and/or FDA regulations

  • Ability to exercise good judgment when providing advice based on BMS guiding principles, FDA regulations, guidances, and current regulatory landscape

  • Monitor and maintain expert knowledge of evolving regulatory landscape and ensure direct reports are taking this information into consideration when providing risk assessment and advice

  • Build and maintain positive and strong working relationships within and across departments, including senior Commercial colleagues Legal, Medical, Public Affairs, and Compliance in relation to promotional issues

  • Participates in risk assessment and mitigation discussions in Escalation meetings with senior management

  • Maintains strong and positive working relationships with APLB reviewers and management

  • Oversees advice provided to the development of APLB strategies, sub part e filings regulatory inquiries and discussions with APLB staff

  • Oversee advice and guidance of direct report(s) to the development of draft product labeling to ensure commercially viable US labeling upon which future promotion and advertising

  • Ensures that changes in US PI are reflected in current promotions and advertising

  • Develop training in FDA regulations for advertising and promotion to employees and agents of BMS

  • Provides recommendations to global marketing on clinical trial design as requested with regard to promotability of potential data/claims as needed

  • Leads special projects and activities as needed

Qualifications:

  • BS degree required; advanced degree preferred (MS, PhD, PharmD, or JD)

  • Minimum of 5-8 years Regulatory promotional review or 8 to 10 years related pharmaceutical experience (e.g., Medical promotional review)

  • Expert understanding of FDA regulations, guidance, and changing regulatory landscape

  • Experience providing strategic direction and risk assessment to interdisciplinary teams on promotional materials activities for marketed and investigational products

  • Demonstrated ability in negotiation, strategic thinking, problem solving, project management and decision making

  • Established ability to develop a strong understanding of business goals for assigned business franchises, marketing concepts and tools

  • Proven ability in managing people and providing coaching and feedback on development

  • Strong leadership skills with demonstrated ability to lead teams and collaborate across key cross functional departments/stakeholders

  • Proven ability to analyze and interpret efficacy and safety data

  • Experience with OPDP interactions related to promotional activities

  • Organizational skills and ability to pay attention to details

  • Experience independently managing and leading individuals, teams, and assigned projects

  • Excellent verbal and written communication skills

  • Superior interpersonal skills, flexibility, and ability to embrace changing environments Strong interpersonal skills; ability to interact with staff and management on all levels, including matrix partners

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.

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 any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Company: Bristol Myers Squibb

Req Number: R1541369

Updated: 2021-06-16 02:12:05.186 UTC

Location: Summit,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.

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