Risk Management Lead

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through (link removed) 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.

Employer: Bristol-Myers Squibb Company
Position: Risk Management Lead (ref.# 9262)
Location: 3551 Lawrenceville Road, Princeton, NJ 08540

Duties: Use experience with: operations and compliance; adverse events; drug safety reporting requirements, guidelines and processes; sections of US and foreign product labels; SUSAR (Suspected Unexpected Serious Adverse Reaction) identification; proper and legal product dosage and indications; drug safety processes and workflow; FDA and ICH guidelines for drug and device reporting; and clinical trials structure and reporting requirements; and project management skills to enable corporate and Research and Development (R&D) objectives and support Quality by Design principles by collaborating to establish, maintain and operationalize framework for Clinical Risk Management, in partnership with stakeholders across R&D and Global Quality. Collaborate with the study teams and help implement Quality by Design from protocol development and study startup, to database lock, and data analysis to ensure appropriate cross-functional coordination of risk assessment and management throughout the duration of Clinical Trials. Facilitate relevant discussions with the study Risk Team (i.e. team responsible for the Risk Assessment and Categorization Tool [RACT]), while working closely with all functions involved to assure alignment on the Quality Threshold Limits (QTLs) and the Risk-Based approach to monitoring with proper documentation of actions and accountabilities. During the identification of potential clinical external partners (Contract Research Organizations, specialty labs, etc), work on the technical assessment as part of the due diligence process, to determine Quality and Compliance capabilities and health of the Quality Management System of the potential partner. Work closely with the Clinical Trial Planning and Alliance Management team as well as the Global Quality organization to develop appropriate Quality Agreements and Quality Oversight management plans with partners. Assist/Support day-to-day vendor oversight and ensure appropriate documentation of such. Perform ongoing assessment of the effectiveness of the Risk Mitigation activities and escalate to the right level of Governance as needed. Support clinical study teams to be inspection ready at all times and coordinate Inspection Preparedness efforts and support sponsor audits and inspections in partnership with Global Quality. Serve as Corrective Action Preventive Action (CAPA) lead and support individual CAPA owners to conduct root cause analyses, develop mitigation plans, and implement CAPAs within prescribed deadlines. Advise the Clinical Training, Process and Continuous Improvement team as to training needs and provide input into Quality Improvement Plans.

Requirements: Bachelors degree (or foreign equivalent) in Pharmacy, Pharmaceutical Management, Health or Life related Sciences plus 2 years of experience reflecting demonstrable ability in the skill set described above.

*** This position is eligible for our employee referral program.


Contact:

Althea Wilson
Bristol-Myers Squibb Company
4931 George Road
Tampa, FL 33634
(e-mail removed)

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

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