Director, Medical Review Group & Medical Safety Assessment, Project Management - #604618

Bristol Myers Squibb


Date: 11/26/2021 01:00 AM

City: Far Hills, New Jersey

Contract type: Full Time

Work schedule: Full Day

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.


Functional Area Description


Worldwide Patient Safety is responsible for ensuring the safety of our medicines: The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-marketing commitments and ensuring compliance with global regulatory requirements. Medical Safety Assessment (MSA) characterizes the safety profile for BMS products via the collection, assessment, aggregation, and submission of safety data. MSA contributes to the development strategy of products by delivering effective risk management and contributing to the study design, analysis, and compliant reporting of safety matters.


Position Summary


Medical Review Group (MRG), Project Management


Supports the MRG Operational Chair and the MRG subcommittee Operational Chairs (MRG-Human Exposure Subcommittee, Non-Clinical-Expedited Safety Report Subcommittee, and MRG-PS overseeing Pediatrics) to facilitate key operational aspects associated with MRG meetings, memo management, and tracking implementation of MRG decisions.


This role provides an opportunity to regularly interact with senior leadership within R&D and within WWPS and to engage and connect across functions within the organization. In this role, the Director needs to be able to identify and summarize the key scientific aspects and implications of safety issues in order to effectively communicate with the MRG Chair and Co-Chairs, which include the Chief Medical Officer and the Heads of Medical and WWPS, as well as drug development project managers and team members. The Director, in collaboration with the Operational Chair, is responsible for determining what safety issues are escalated to the MRG Chairs and how those issues are escalated (e.g. offline memo or MRG meeting).


Working with MRG Chairs to obtain offline approvals for urgent and non-urgent topics (e.g. Urgent Safety Measures, Dear Healthcare Provider Letters, medical assessments, etc.). This may require off hours or weekend work for Urgent Safety Measures; summarizing the output of the Safety Management Team for MRG chairs.


Medical Safety Assessment (MSA), Project Management


Ensures effective startup, planning, execution, and evaluation of major projects with R&D and WWPS with strategic implications for MSA in collaboration with the Project Management Office. The role requires coordination between projects to identify and manage interdependencies as well as understanding and communicating resource and budgetary impacts to MSA leadership and to the Project Management Office.


Position Responsibilities


  • Working with MRG Chairs to obtain offline approvals for urgent and non-urgent topics (e.g. Urgent Safety Measures, Dear Healthcare Provider Letters, medical assessments, etc.). This may require off hours or weekend work for Urgent Safety Measures; summarizing the output of the Safety Management Team for MRG chairs.


  • Working with the MRG Operational Chair, MRG subcommittee Operational Chairs, and Administrative Assistant to schedule meetings


  • Coordinating plans with asset teams to align with other governance meetings.


  • Drive transparency of the MRG-HES book of work, including decision making across different products.


  • Communicating with the drug development team project managers and team members to ensure that meeting materials are adequate and provided in a timely manner for MRG meetings


  • Preparing meeting summaries and following through on obtaining the appropriate reviews and approvals for these summaries. Ensure key communication points are captured and disseminated.


  • Tracking and maintaining list of MRG decisions and actions


  • Ensuring that decisions of the MRG and its subcommittees are communicated to functional leads responsible for implementing the outcomes.


  • Developing and maintaining the MRG SharePoint site, training, slide templates, and development and maintenance of FAQs.


  • Ensuring timely entry of NTM (notification to management) into Infinity with regard to MRG topics


  • Collaborating with internal partners on key projects to support department and enterprise initiatives.


  • Coordinating startup, planning, execution, and evaluation of MSA projects


  • Partnering with the Project Management Office and PMO Community of Practice to ensure alignment with WWPS portfolio planning and project management standards, processes and tools where applicable


  • Communicating resource and budgetary impacts to MSA leadership and to the Project Management Office.


Position Requirements


  • Bachelor’s degree required; advanced scientific degree or equivalent experience strongly preferred.


  • 8 or more years of relevant industry experience. Experience in drug development (early through marketed), scientific writing, and reporting requirements are required.


  • Advanced project management skills and relevant experience on matrix management, metrics and senior leadership communication


  • Motivated individual possessing strong communication skills and ability to proactively work effectively with cross functional teams


  • Effective communication skills (written and spoken) and organizational skills are a necessity


  • Ability to work flexibly and with short deadlines


  • Occasional travel within the US e.g. twice per month


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.


To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.


Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.


Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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