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Senior Manager, Global Risk Management

Bristol Myers Squibb Company

This is a Contract position in Princeton Township, NJ posted July 21, 2020.

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.

Global Risk Management Senior Manager, Therapeutic Area Summary The Global Risk Management (GRM) Senior Manager, Therapeutic Area (TA) reports to the GRM Lead, TA.

Preferred locations are Summit NJ, Princeton NJ, Seattle WA, Uxbridge UK, or Melbourne Australia.

It is focused 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.

Responsibilities Supports the GRM Lead TA 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 Contributes to the development of therapeutic area RMPs as core team reviewer, including any additional risk minimization measures (aRMM) and additional pharmacovigilance (PV) activities (APVA) Participate in product-centered RMP cross-functional Implementation Teams for those products with Health Authority (HA)-mandated aRMM Develop and update Global educational materials that are aRMM in conjunction with GRM Lead TA, SMT Chair, Headquarters (HQ) Medical, and Global Regulatory Team Lead (GRTL) Support LM when implementing aRMM and APVA Global/Regional (eg, EEA), and/or local commitments Collaborate with GRM Lead TA 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 (eg, Country-Specific Annex/Addendum, LM RMP Summary, Implementation Reports).

Provide guidance and support to LM PV for development of these documents Support GRM Publishing in their development, implementation, and optimization of RMP tracking and activity tools, eg, RMP Tracker/Verity, Local Market Implementation tracker (LMIT), ARMA/APVA Book of Work, and GRM SharePoint Participate in the Risk Management Strategy Committee (RMSC) as directed by GRM Lead TA Participate in International PV Meetings as directed by GRM Lead TA 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 Other responsibilities as assigned Requirements: Advanced scientific degree preferred More than 7 years of relevant pharmaceutical industry experience Experience in global pharmaceutical risk management required Understanding of pharmacovigilance/regulatory environment is expected Skills/Knowledge Required: 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 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.