Bristol-Myers Squibb Company

Associate Director, Global Regulatory Business Capabilities Strategist

Location
Princeton, NJ, US
Posted
Nov 21, 2018
Ref
R1511723
Required Education
Bachelors Degree
Position Type
Full time
BMS maintains a project road map to maintain and optimize the Regulatory capabilities required to support the full range of Global Regulatory activities. This position will have responsibility for the strategic direction and development for assigned Regulatory projects included on this road map. This position will also support ongoing implementations where needed and as assigned. The GRBC Strategist may become the business lead for a specific capability and in this role, would take into account both the internal and external environments, serve as the BMS process and requirements expert for all aspects of assigned capability.

Proactively develops strategy and business plans to optimize assigned BMS regulatory capabilities to deliver assigned Road Map projects including:
  • For an existing capability:
    • Enables strategic direction and evolution of the production environment
    • Maintains knowledge of business processes configured in the assigned system
    • Understands the evolving business partnership landscape at BMS and act on the impact of these changes on the business processes
    • Develop short- and long-term goals for assigned capability
    • Escalate recommendations on issues or changes to governance boards for decisions, as needed
    • Escalate data quality issues to the data compliance steward and supports resolution
  • For a planned capability:
    • Leads/participates in initial scope meetings with matrix team and in collaboration with Information Technology Business Partners
    • Participates in the vendor selection process, in collaboration with Information Technology Business Partners, Procurement and other involved parties
    • Help set the direction of process definition, if applicable
    • Is involved in several aspects of the implementation program


Maintains assigned regulatory systems and processes by:
  • Communicating with process owners when needed
  • Leading functional and cross functional teams for delivery of system releases, in collaboration with Information Technology Business Partners
  • Participating / supporting system validation and testing plans. Review and execute test scripts.
  • Providing support for internal audits, HA inspections and corrective action plans.
  • Leading regular communication with end-users. Review and approve knowledge articles when needed. Lead user group sessions.


  • Some travel may be required once or twice a year

(Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Experience and Educational Requirements
  • BS in a relevant scientific or technical field and 5-10 years of relevant pharmaceutical industry experience; or a MS with 4 years of relevant pharmaceutical industry experience. Minimum of 2 years work in Regulatory Affairs.
    • Demonstrates experience and understanding of the procedures and decision-making process of the Health Authorities.
    • Strong knowledge and experience with regulatory systems
    • Strong understanding of regulatory operations
  • Firm, detailed knowledge and experience with computer systems in an R&D environment. Expertise in system validation, testing methods, GAMP guidelines and electronic records regulations. Ability to evaluate user acceptance criteria.
  • Experience in dealing with internal customers and supervising external contractors.
  • Able to adapt easily to new software and procedures.
  • Excellent command of English language, both written and oral. Strong presentation skills.
  • Ability to solve problems, with track record of success in implementation of cross functional projects


Other Qualifications:
  • The ability to network with other BMS functional areas to gain broad perspective when developing strategies, processes and tactics. Collaborates across cultural and organization boundaries to achieve business results.
  • Participates in personal development of self and others with supervisor by providing and asking for continuous and honest feedback. Demonstrates commitment to BMS enterprise by developing and mentoring colleagues
  • Maintains a positive work environment with sensitivity to the balance between personal and professional life.