• Job Description

  Req#: R1572459

  Working with Us
  Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

  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. Read more: careers.bms.com/working-with-us .

  Functional Area Description

  Regulatory Information and Submission Management is an organization that delivers Health Authority submissions and product data to support the BMS portfolio and sets the strategic business direction and related processes oversight for GRS systems.

  Position Summary / Objective

  The Manager, Medicinal Product Data Management supports the EVMPD (Extended EudraVigilance Medicinal Product Dictionary) Operations Group. This role will also support future MPDM health authority data requirements and deliverables.

  This role will collect EVMPD and IDMP data, perform data entry, QC, and data maintenance support to maintain compliance with current EVMPD regulations and to meet upcoming global regulatory requirements for submission of IDMP data based on local implementation guides.

  Position Responsibilities

  • Performs EVMPD maintenance coordination through data collection, data entry and data QC for EVMPD
  • Maintains understanding of the assigned EVMPD Processes and IDMP business processes
  • Manages daily workload and independently addresses questions for assigned regulatory processes
  • Lead and contribute to enhancements in developed areas of expertise
  • Provides support for internal audits, HA inspections and corrective action plans.
  • Support Veeva enhancements as they relate to xEVMPD and IDMP
  • Supports management in developed areas of expertise
  • Trains, coaches, and provides day-to-day support for junior specialistsRecognizes and reports data compliance issues and how they impact assigned processes
  • Executes operational aspects of enabled processes according to BMS procedures
  • Create, update and/or execute new reports in RIM system for any new data entries or updates to existing product data
  • Collaborate with stakeholders and SMEs to find solutions and rectify any ongoing or potential issues
  • Support projects related to
  • Recognizes and reports data compliance issues, and able to derive how they impact assigned processes and other processes
    

  Degree Requirements

  BA/BS degree, science / technology field preferred
  

  Experience Requirements

  7-10 years of pharmaceutical experience
  

  Key Competency Requirements

  • Experience with the life cycle of marketed products (preferred, but drug development experience will also be considered) processes.
  • Solid regulatory knowledge and previous experience in the Regulatory Information Management area
  • Demonstrate experience and understanding of the procedures and decision-making process of Health Authorities as it relates to RIM.
  • Clear knowledge and experience with EVMPD, IDMP, and/or SPOR.
  • Possesses knowledge in standard desktop applications and RIM systems, including effective troubleshooting skills.
  • Easily adapts to new software and procedures.
  • Strong attention to detail.
  • Excellent command of English language, written and oral.
  • Demonstrated ability to follow specific standards and processes and ability to identify when others do not.

  If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

  Uniquely Interesting Work, Life-changing Careers
  With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

  On-site Protocol
  Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

  BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

  BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

  BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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

• About the company

  BMS' primary R&D sites are located in Lawrence, New Jersey, New Brunswick, New Jersey, and Redwood City, California; with other sites in Devens and Cambridge, Massachusetts, East Syracuse, New York, Braine-l'Alleud, Belgium, Tokyo, Japan, Bangalore, In...

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