Manager Medical Device Safety

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.

This is a global role which supports the Worldwide Patient Safety Vision through understanding the impact of daily work on all stakeholders of Safety Data Processing. This role provides oversight of quality and process optimization through a Business Partner Model working with multiple global stakeholders across WWPS and external functions to ensure business critical safety data processing to support regulatory obligations. Primary focus includes design, implementation and support of business processes related to product quality complaints, regulatory reporting, and clinical development of BMS medical device/Combination Products. Strong knowledge of global regulations/legislation and device industry best practices is a key requirement as this role must provide oversight of and content contribution to both clinical trial and post-marketing surveillance, specifically Medical Device Reporting (MDR) and medical device analysis.

The final role of Senior/Manager will be based on qualifications and years of relevant experience.

Position Responsibilities

• Identify and develop process improvements within selected projects to meet short and long-term objectives including but not limited to compliance, productivity and quality, work in a matrix environment to facilitate the allocation of required project resources and deliver feedback on project deliverables.
• Serve as a Subject Matter Expert (SME) on safety reporting requirements for medical devices and combination products.
• Ability to review, understand and design safety reporting requirements for medical devices and combination products to meet global regulations.
• Conduct thorough and careful analysis of project requirements and deliver quality solutions to critical business projects.
• Proactively identify key project issues and identify potential solutions to effectively streamline processes as well as work effectively with project teams, business partners, vendors, and colleagues to ensure solutions are implemented in a timely and concise manner.
• Exercise a high degree of adaptability in dealing with an ambiguous and complex work environment which includes demands from respective project teams and impacted internal and external stakeholders.

• Based on project plans and goals, establish strong working relationships and responsibility within -WWPS.
• Manage day-to-day operational aspects of a project and scope including but not limited to keeping the team well informed of updates and changes.
• Effectively communicate relevant project information to team members and leadership.
• Communicate effectively with business partners and vendors to identify needs and evaluate alternative business solutions.

Position Requirements

• Bachelor’s degree, Scientific/medical background (B.S/B. A) in Life Science, Nursing, Regulatory Affairs, Chemistry or Pharmacy preferred
• A minimum of 3-5 years’ experience in processing serious adverse events and medical device reports (MDRs) from clinical studies and post-marketing reports
• Demonstrated ability to analyze and interpret complex problems/data gathered from a variety of sources and, through effective decision-making and planning, delivers superior business solutions
• Demonstrated ability to work with a range of technically and culturally diverse people, influencing them to accomplish common goal
• Experience to supervise a team of individuals successfully and productively
• Demonstrated ability to effectively communicate to a diverse audience, at multiple levels within the company, through various formats, i.e., presentations, written proposals/reports/correspondence, leading meetings, face to face dialogue

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.

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