Bristol Myers Squibb Company

Global Risk Management (GRM) Manager, Cell Therapy

Location
Celgene, NJ, United States
Posted
Sep 06, 2020
Ref
R1528307
Required Education
Bachelors Degree
Position Type
Full time
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) Manager, TA Cell Therapy reports to the GRM Lead, TA Cell Therapy. This role will focus on supporting 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 TA Cell Therapy.

Responsibilities
  • Supports the GRM Lead TA Cell Therapy in developing and implementing RMPs and activities by serving as a bridge between the Safety Management Team (SMT) and International Worldwide Patient Safety (WWPS) Team as appropriate
  • Assist in the development of therapeutic area RMPs, including any additional risk minimization measures (aRMM), educational materials, and additional pharmacovigilance (PV) activities (APVA) in conjunction with GRM Lead TA Cell Therapy, SMT Chair, Headquarters (HQ) Medical, and Global Regulatory Team Lead (GRTL)
  • Serve as contributing reviewer on Global RMP and EU RMP authoring teams for therapeutic area
  • Assist in product-centered RMP cross-functional Implementation Teams for those products with Health Authority (HA)-mandated aRMM
  • Support LM during development of and when implementing RMP, aRMM and APVA Global/Regional (e.g., EEA), and/or local commitments
  • May collaborate with GRM Lead 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, support LM PV with development as needed
  • Support LM to address RMP-related queries from Local HA
  • Contribute to HA responses arising from Rapid Response Teams (RRTs) for HA queries, ensuring alignment with the BMS Company risk management position and strategy
  • Liaise with GRM Publishing regarding the planned schedule of LM RMP and RMP-related documents (e.g., Country-Specific Annex/Addendum, LM RMP Summary, Implementation Reports)
  • May support GRM Publishing in their development, implementation, and optimization of RMP tracking and activity tools, e.g., RMP Tracker/Verity, Local Market Implementation Tracker (LMIT), ARMA/APVA Book of Work, and GRM SharePoint
  • May participate in the Risk Management Strategy Committee (RMSC) as directed by GRM Lead TA Cell Therapy
  • Participate in International PV Meetings as directed by GRM Lead TA
  • May support GRM Center of Excellence regarding procedural document updates and maintenance of inspection readiness, and provide RMP-related metrics as requested
  • Maintain a thorough understanding of GRM regulations, and industry trends regarding the implementation of GRM
  • Support aggregate report preparation, as needed
  • Other responsibilities as assigned


Requirements:
  • Advanced scientific degree preferred
  • More than 5 years of relevant pharmaceutical industry experience
  • Experience in global pharmaceutical risk management preferred
  • Understanding of pharmacovigilance/regulatory environment is expected


Skills/Knowledge Required:
  • Proven ability to foster partnerships across companies and organizational boundaries
  • Demonstrated ability working in cross-functional teams, and driving decisions that involve multiple constituencies and constraints
  • Excellent listening and analytical skills, along with excellent written, verbal and interpersonal communication skills
  • Thorough understanding of GRM regulations
  • 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.