Bristol-Myers Squibb Company

Medical Review Group/ Safety Assessment Committee Project Manager

Location
Princeton, NJ, US
Posted
Oct 25, 2018
Ref
R1508928
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.

MRG/SAC PM Job Description:

The Medical Review Group (MRG) and Safety Assessment Committee (SAC) Project Manager supports the MRG Operational Chair, the MRG subcommittee Operational Chairs (MRG-Human Exposure Subcommittee and Non-Clinical-Expedited Safety Report), and SAC Chair (Head of Medical Review Safety Physician group) to facilitate key operational aspects associated with MRG meeting, memo management, and ensuring implementation of optimal operational strategies of the SAC to evaluate anticipated events per FDA regulation.

This role provides an opportunity to regularly interact with senior leadership within R&D and within GPV&E and to engage and connect across functions within the organization. In this role, the project manager 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 Chairs and Co-Chairs, which include the CSO and the Heads of Medical and GPV&E, as well as drug development project managers and team members. The Project Manager, 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). The manager will also collaborate with internal partners (e.g. Medical Safety, Biostatistics, Epidemiology) and external partners (e.g. academic experts, global health authorities) to ensure the SAC conducts appropriate safety monitoring of anticipated events across all functional areas, and adherence to FDA requirements.

Responsibilities include:
  • 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 MST for MRG chairs.
  • Drive transparency of the SAC and MRG-HES book of work, including decision making across different products
  • Partner strategically with the SAC Chair to facilitate the development and execution of safety surveillance plans for assigned products. Ensure surveillance plan is aligned with TA portfolio objectives/strategies
  • Working with the MRG Operational Chair, MRG subcommittee Operational Chairs, and Administrative Assistant to schedule meetings
  • 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
  • Partner with SAC Chair to facilitate SAC meetings and ensure the agenda is focused on key deliverables, risk management, issue identification and resolution. Ensure that key actions and agreements are understood and the team is held accountable for their commitments
  • Preparing meeting summaries and following through on obtaining the appropriate reviews and approvals for these summaries. Ensure key communication points are captured and disseminated.
  • Maintain Safety Surveillance Plans and manage dependencies across functions and geographies and provide transparency to SAC Chair and senior leaders. Prepare comprehensive project plans and progress reports for team leads, senior management and other stakeholders
  • 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, and development and maintenance of FAQs.
  • Identify, develop and implement new processes to facilitate continued evolution of the SAC function and improve efficiency


Qualifications:
  • BS, with advanced scientific degree or equivalent experience preferred
  • 5 or more years of relevant industry experience. Experience in drug development (early through marketed) and reporting requirements are required. Medical safety surveillance or clinical experience is preferred
  • Advanced project management skills and relevant experience on matrix management, budget 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