Position SummaryThe 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 ResponsibilitiesResponsibilities 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
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We WorkWhere you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
