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Job Details


Bristol Myers Squibb

Manager, Global Regulatory Science CMC Operations (R1556633-en-us)

Operations

Security Operations

Yearly

No

Princeton, New Jersey, United States

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

The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a products lifecycle. Members of the organization develop global regulatory CMC strategies and collaborate with key stakeholders to execute the strategies in alignment with business priorities. The team also perform regulatory assessments for manufacturing changes, provides guidance on regulatory expectations for medical devices, oversees TSE/BSE program & provides compliance documents to support Health Authority submissions. The team also supports Medical Information to build/maintain database to address external questions regarding drug products.

Position Summary / Objective

The GRS-CMC Operations Manager will collaborate with stakeholders across functional area to enhance business processes and provide strategic input for the change control, Regulatory Information Management (RIM), and dossier authoring, publishing and viewing IT systems.

Position Responsibilities

The GRS-CMC Operations Manager is responsible for the following

  • Provide support to and serve as subject matter expert for the change control and RIM electronic systems used by GRS-CMC.

  • Support data quality initiatives in regulatory systems

  • Provide formatting and document support for the regulatory authoring system. Facilitate publishing and review in BMS document viewers.

  • Support the preparation of GRS-CMC procedural documents.

  • Support other Operations logistical activities, such as Onboarding of New Hires

  • Establish strong working relationships with CMC Leads and other stakeholders

Degree Requirements

Minimum BA/BS Degree

Experience Requirements

  • Minimum 2+ years pharmaceutical or related experience, prefer multidiscipline.

  • Knowledge of data management systems with ability to execute business requirements.

  • Knowledge of CMC regulatory requirements during development and post-approval phases is preferred.

  • Knowledge of Infinity Change Control system, Verity RIM system, and/or CARA dossier authoring/publishing system is preferred.

  • Ability to develop/maintain strong working relationships, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.

  • Ability to identify, communicate and resolve routine/complex issues.

  • Organizational skills and attention to detail

Key Competency Requirements

  • Demonstrate leadership capability with ability to act on decisions while balancing speed, quality and risk Ability to provide strategic and innovative ideas that create value without compromising compliance Ability to build strong relationships and alignment with business partners Strong oral and written skills Proficient with electronic systems

  • Knowledge of data management systems with ability to execute business requirements.

  • Knowledge of CMC regulatory requirements during development and post-approval phases is preferred.

  • Knowledge of Infinity Change Control system, Verity RIM system, and/or CARA dossier authoring/publishing system is preferred.

  • Ability to develop/maintain strong working relationships, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.

  • Ability to identify, communicate and resolve routine/complex issues.

  • Organizational skills and attention to detail

  • Minimum 2+ years pharmaceutical or related experience, prefer multidiscipline.

Travel Required

No

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.