Senior Manager, Risk Evaluation and Mitigation Strategies (REMS) Strategy and Submissions

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Summary The Senior Manager of REMS Strategy and Submissions reports directly to the Director, REMS Strategy and Submissions and will be responsible for strategic and operational aspects for REMS programs including REMS submissions readiness packages to the FDA for REMS programs in the US.

Responsibilities will include, but are not limited to the following: Support to relevant REMS submissions teams (e.g., Regulatory, Global Submission Management) to ensure that all projects are within scope and budget, and submitted to the FDA on-time Creating short and long-term plans Support strategic planning including setting targets for milestones and adhering to deadlines as directed by REMS Strategy Leads Map overarching submission timelines for REMS submissions for each product to ensure submissions are met within the expected due dates leading up to FDA submission Assist in the definition of project scope, collaborating with all relevant internal stakeholders and ensuring feasibility with REMS Strategy Leads Ensure resource availability and allocation based on projections of REMS submissions and overall activity. Develop a detailed project plan to monitor and track progress for REMS submissions to the FDA Manage the relationship with relevant stakeholders and facilitate meetings with generic manufacturer (s) for the appropriate REMS as needed Establish and maintain relationships with third parties/vendors/partners Lead regularly scheduled meetings with vendors. Update REMS documents in coordination with third-party vendors as applicable based on guidance from REMS Strategy Leads Participate in drafting responses to FDA Information Requests Participate in review and editing of REMS documents, including but not limited to REMS Assessment Reports and REMS Modifications Participate in meetings with the FDA related to BMS REMS programs Attend conferences and training as required to maintain proficiency Perform other related duties as assigned Ensure submissions updates for generic manufacturers, cross reference letters & LOA are distributed as applicable Support to generic manufacturers for on-boarding and maintenance of inquiries, including resolution of issues Maintain Readiness Go-Live scheduling for Quality/PV, Call Center/Portal Demo and IT Readiness ensuring speakers are aligned & internal preparation meetings are scheduled prior. Qualifications & Experience BS/BA required, a dvanced degree in healthcare science, public health, or applicable fields, preferred . Prior pharmaceutical industry experience (5-7 years) in relevant area (e.g., Risk Management, Medical Communications, Medical Affairs, Regulatory, or Safety/Pharmacovigilance). Prior REMS experience preferred Excellent client-facing and internal communication skills Excellent written and verbal communication skills Solid organizational skills including attention to detail and multitasking skills Strong working knowledge of Microsoft Office US regulatory knowledge and REMS experience is preferred Desired Competencies Demonstrated ability working in and leading cross-functional teams, work independently and drive decisions that involve multiple constituencies and constraints Ability to independently manage multiple projects with accountability and excellent work ethic A high level of organization, acute attention to detail and time management skills Excellent listening and analytical skills, along