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.
The Global Risk Management (GRM) Senior Manager, Solid Tumors reports to the GRM Lead, Solid Tumors. Preferred locations are Summit NJ, Princeton NJ, Seattle WA, Uxbridge UK, or Melbourne Australia. This role is focused on supporting and leading the development of Global, EU, and Local Market (LM) Risk Management Plans (RMPs), and driving LM implementation activities for specific products as directed by the GRM Lead, Solid Tumors. Responsibilities:
- Accountable for global development and implementation of RMPs and activities, including by serving as the key bridge between the Safety Management Team (SMT) and International Worldwide Patient Safety (WWPS) Team.
- Leads the development of Solid Tumors therapeutic area RMPs as core team reviewer, including any additional risk minimization measures (aRMM) and additional pharmacovigilance (PV) activities (APVA).
- Manages the strategic development and update of Global/EU educational materials that are aRMM in conjunction with GRM Lead Solid Tumors, SMT Chair, Headquarters (HQ) Medical, and Global Regulatory Team Lead (GRTL).
- Leads product-centered RMP cross-functional Implementation Teams for those products with aRMM.
- Provides guidance and support to LM PV during development of and when implementing RMP, aRMM and APVA Global/Regional (eg, EEA), and/or local commitments.
- Collaborates with GRM Lead, Solid Tumors in protocol development for Non-Interventional Research (NIR) protocols for Post-Authorization Safety Studies (PASS), including evaluations of effectiveness of risk minimization and APVA or programs (Global and EU). For LM protocols, supports LM PV with development as needed.
- Expert contributor to Health Authority (HA) responses arising from Rapid Response Teams (RRTs) for HA queries, ensuring alignment with the BMS Company risk management position and strategy. Supports LM PV to address RMP-related queries from Local HA
- Supports aggregate report (eg, DSUR, PBRER/PSUR) preparation, as needed.
- Liaises with GRM Publishing regarding the planned schedule of LM RMP and RMP-related documents (eg, Country-Specific Annex/Addendum, LM RMP Summary, Implementation Reports).
- Supports GRM Publishing in their development, implementation, and optimization of RMP tracking and activity tools, eg, Regulatory Information Management System (Verity), RMP Tracker, Local Market Implementation Tracker (LMIT), aRMM/APVA Book of Work, and GRM SharePoint.
- Supports preparation of meeting materials and participates in SMT Meetings and the Risk Management Strategy Committee (RMSC) as directed by GRM Lead, Solid Tumors.
- Participates in International PV Meetings as directed by GRM Lead, Solid Tumors.
- Supports Regional WWPS Leads as directed by GRM Lead, Solid Tumors.
- Supports GRM Center of Excellence regarding procedural document updates and maintenance of inspection readiness, and provides RMP-related metrics as requested
- Maintains a thorough understanding of GRM regulations and industry trends regarding the implementation of GRM.
- Other responsibilities as assigned.
- Advanced scientific degree preferred
- More than 7 years of relevant pharmaceutical industry experience
- Experience in global pharmaceutical risk management required
- Thorough understanding of pharmacovigilance/regulatory environment is expected
- Thorough understanding of GRM regulations
- Proven ability to foster partnerships across companies and organizational boundaries.
- Demonstrated ability to lead cross-functional teams, work independently, and drive decisions that involve multiple constituencies and constraints.
- Creative thinker, excellent listening and analytical skills, along with excellent written, verbal and interpersonal communication skills.
- Advanced user of Microsoft Office tools.
- Occasional travel required.
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.