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Associate Director, GxP External Engagement

Bristol-Myers Squibb Company

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New Brunswick, NJ
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Job Description

As posted by the hiring company

Job Overview:

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.

Bristol Myers Squibb is looking for a remarkable Associate Director, GxP External Engagement who will play a key role in ensuring that BMS is recognized by regulatory authorities and industry peers as a thought leader in the areas of innovation, science, technology, quality and compliance by supporting and contributing to the execution of the GxP external engagement strategy.

Role Responsibilities:

  • Support the Director, GxP External Engagement, effectively communicate the outcomes of external engagement across the organization and ensure a closed loop mechanism to drive company action and impact where needed.

  • Timely identify and assess emerging topics/expectations to define the company´s strategy and involvement.

  • Benchmark best practices in the industry to continuously improve internal processes and systems for development and manufacturing.

  • Actively participate in Trade association meetings to develop relationships and build intelligence on upcoming regulatory changes and emerging compliance expectations that impact Quality, Compliance & Operations functions. Communicate learnings through established processes and relationships across the network.

  • Lead external engagement Community of Practice around priority topics.

  • Support the routine compliance surveillance activities to detect, monitor, collate and communicate global compliance trends which could impact GPS operations.

  • Identify, assess, and communicate emerging surveillance of regulatory and compliance landscape through the timely authorship and review of FLASH Reports and Regulatory Surveillance Yammer postings.

  • Enhance communications with the Quality Councils, to ensure proactive engagement and continuous improvement.

  • Support data-driven insights into compliance performance and opportunities for improvement.

Role Requirements:

  • Bachelor's degree in pharmaceutical sciences, regulatory affairs, engineering, biology, or other related discipline or equivalent combination of education and experience

  • 7+ years of FDA or other health authority experience, or a combination of health authority (HA) and biopharmaceutical industry experience.

  • Experience within regulatory agencies working with Bio/Pharmaceutical Industry, including leadership experience in Clinical Studies, Quality, Manufacturing, Regulatory and/or Product Development.

  • Significant understanding and track record in dealing with international regulation and policy development processes of major regulatory agencies

  • Understanding of technical areas related to pharmaceutical and/or biological manufacturing, clinical study, regulatory and or quality control/quality assurance processes

  • Comprehensive understanding of one of more GxP areas and willingness to expand knowledge into other areas.

  • Experience in global or regional clinical operations or biologic products is preferred

  • Up to 50% travel required

#LI-Hybrid ​BMSBL

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.