About this role
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.
Position 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.
Key Responsibilities
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, advanced 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 with excellent written, verbal, interpersonal communication, and critical thinking skills
Adaptive, resilient, and nimble character, yet firm and sturdy in conviction and ethics
Proactively recognizes problems and foresees opportunities with a tendency to act with a solutions-driven attitude
Critical-Thinking - Ability to collect, apply, analyze and evaluate information to reach an answer or conclusion that considers all variables and seeks to achieve the most beneficial result. Anticipates results, both desirable and undesirable, and integrates into decision-making process
#LI Hybrid
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview
Princeton - NJ - US: $128,760 - $156,024