Job Description

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.

Summary

The Global Risk Management (GRM) US REMS Strategy and Submissions Program Lead reports to the Lead, US REMS Strategy and Submissions. The purpose of this role is to serve as a US REMS expert and liaison with the GRM Therapeutic Area (TA) team members to support Risk Management (RM) submissions to FDA for assigned products.     

Responsibilities

The US REMS Strategy and Submissions Program Lead reports to the Senior Director of US REMS Strategy and Submissions and will be responsible for leading the development and submission activities (to FDA) in support of, and the assessment of assigned REMS programs. This Lead will work with cross-functional BMS teams and the overarching GRM Department to develop and produce REMS program content. He/she will be responsible for the delivery of REMS documents to support the launch and commercialization of BMS products.

The Lead will also be responsible for account management in the delivery of internal and external US REMS communications, developing strong relationships with partners, connecting with key business executives and stakeholders, managing multiple projects, preparing status reports, understanding fiscal responsibilities, and the provision of data to external partners. Additional assigned REMS-driven projects could include supporting the development, standardization, and improvement of departmental processes/SOPs, being responsible for analysis and delivery of department metrics, publication planning, and/or supporting RM policy efforts. The US REMS Strategy and Submission Program Lead understands existing and emerging global RM legislation and regulations and effectively communicates opportunities and issues across multifunctional internal groups to ensure the success of BMS’s RM implementation in the US. 

Responsibilities include, but are not limited to the following:

• REMS program development and regulatory submissions

  • Manage the submission strategy, development, internal reviews and approvals of REMS content and program components (including REMS modifications, NDA/sNDA/BLA/sBLA risk management submissions, communications, etc.) for NDA/BLA submission to the FDA for assigned REMS programs.

  • Liaise with internal BMS multidisciplinary REMS stakeholders (Submission teams, Lead Safety Physicians, Regulatory Affairs, Biostats, Regulatory Operations, GRM Technology, GRM Center of Excellence, and Legal) to keep track of and ensure capture of updates within RM submissions

  • Serve as RM material project champion to foster the review and approval of REMS materials in need of multidisciplinary review and approval

  • Direct internal and external teams and vendors to create and supply the necessary components to complete the submission

  • Serve as a primary US REMS contact between BMS and external stakeholders

  • Manage relationships with project stakeholders, including internal and external clients and vendors

  • Responsible for program budgeting and proactively identifies changes in work scope to ensure appropriate planning measures are taken with internal and external clients to reassess and amend the scope of work requirements, budget, and timelines

  • Utilize project management skills to ensure high quality deliverables are provided in a timely manner

  • Drive the narrative development process and data analysis of high-quality health authority deliverables such as REMS Assessment Reports, ad hoc survey results, and responses to Regulatory Agencies from inquiries.

• GRM/REMS Advocacy and Policy

  • Participate in GRM and REMS activities as requested by internal and external industry groups (e.g. PhRMA, BIO)

  • Develop and execute an internal awareness/training program about US REMS activities

• REMS Strategic and Leadership Role

  • Lead internal audit and regulatory inspection activity as needed

  • Represent US REMS on cross functional projects

  • Provide scheduled and ad-hoc reports to the leadership team as required

  • Assist with ad hoc projects and additional tasks as assigned

  • Front/back-office SME during FDA inspections

Requirements:

• BS/BA required, advanced degree in healthcare science, public health, or applicable fields, preferred

• 7+ years previous experience in Pharmaceutical Industry (Risk Management Program Operations, Medical Communications, Regulatory, or Safety/Pharmacovigilance or relevant disciplines) preferred

• Ability to independently manage multiple projects with accountability and excellent work ethic

• Excellent and effective verbal and written communication skills with the ability to interface with GRM Leadership team, Worldwide Patient Safety leadership, interdisciplinary submission teams, and external vendors

• Possess knowledge of clinical trials & drug development, commercial drug development, and understanding of safety data capture in clinical trial and post marketing settings.

• REMS document preparation experience

• Appreciation and knowledge of the global safety environment, international regulations, compliance regulations, and guidance documents applicable to risk management (US, EMA, ICH)

• Positive attitude of collaboration and continuous learning and improvement, a must.

• Highly strategic, proactively recognizes problems and foresees opportunities with a tendency to act with a solutions-driven attitude

• Demonstrated high degree of independence with effective presentation and interpersonal skills to ensure a team-oriented approach

• Creative thinker and engaging public speaker

• Occasional travel required

Skills/Knowledge Required:

• Proven ability to foster partnerships across companies and organizational boundaries

• Creative thinker, exceptional listening and analytical skills, along with excellent written, verbal and interpersonal communication skills

• Strong strategic orientation with ability to translate into operational priorities and plans

• Advanced user of Microsoft Office tools

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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