Business Capability Manager, Regulatory Information Management (RIM)
June 21, 2016
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support.  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 the resources to pursue their goals, both at work and in their personal lives.
The Global Regulatory, Safety and Biometrics (GRSB) IT Business Capability Manager is accountable for implementation and evolution of strategic information systems that globally enable the management of regulatory data and content relating to submissions, registrations, commitments, correspondence and country requirements. This role is within the Information Technology group and will partner with GRSB business colleagues, other internal IT service teams, outsourcing partners, vendors to define, plan for, prioritize, deliver and support strategic information management capabilities and to ensure maximum value is achieved.
Specific responsibilities include:
  • Lead the implementation of a new multi-year transformational RIM capability and achievement of business outcomes.
  • Proactively translate business strategies into multi-year capability roadmaps and concrete informatics programs.
  • Lead collaborative efforts with business areas to develop and gain approval for programs that create tangible business value with well-articulated and evidenced based business outcomes.
  • Lead and manage strategic programs, from concept initiation through delivery, including the successful transition of new, validated capabilities into production operations.
  • Proactively engage with interfacing divisions to create process and system interfaces that support the effective use of regulatory information outside of GRSB.
  • Implement program/project governance processes and change management efforts that ensure successful project execution and achievement of high value business outcomes.
  • Lead contracting and procurement of external resources for project-type work.
  • Partner with Global Procurement (GP) to lead the evaluation of commercial products (e.g., software packages) and services and actively steer the negotiation process for vendor products.
  • Lead and facilitate process engineering based on detailed and practical knowledge of the broad range of systems and processes that support GRSB.
  • Develop and implement strategies to ensure effective utilization of RIM capabilities by BMS strategic partners.
  • Proactively research industry and technology trends to inform strategic planning and translate to potential opportunities.

Qualifications Qualifications:
  • Must have at least 8 years of experience in a Pharmaceutical or Biopharmaceutical environment.
  • BS in Science, Engineering, Information Technology or related field required. Graduate Degree or higher level education preferred.
  • Demonstrated experience leading capability implementations and strong life sciences experience.
  • Strong practical working experience with various Regulatory Information Management capabilities within a regulated environment.  Veeva experience desired, but not required. 
  • Demonstrated understanding of drug development process and regulatory operations including command of key concepts, systems and Regulatory processes.
  • Demonstrated strategic leadership & track record of maintaining effective business relationships with Senior Management to ensure Informatics can deliver solutions that align with business strategies and objectives.
  • Demonstrated experience developing and maintaining IT road maps and portfolio management.
  • Demonstrated ability to conduct business analysis, requirements specifications and release planning.
  • Experience in evaluating commercial products (e.g., software packages) and services and influencing the negotiation process for vendor products.
  • Experience with Master Data Management tools and Data Governance and Stewardship principles.
  • Understanding of IDMP
  • Working knowledge of GxP regulations and delivery of IT projects in a GxP environment.
  • Proven abilities to plan, manage, and deliver strategic programs, from concept initiation through delivery.
  • Must possess excellent written and verbal skills and demonstrate an ability to effectively communicate at all levels of the organization including executive stakeholders.
  • Ability to achieve successful consensus among differing priorities and stakeholders in both the IT and Business communities.
  • Effective in cross-functional, multi-site, matrix management and team building.

Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability

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A little about us:
Our shared focus to become a Diversified Specialty BioPharma company is driving us forward. Pioneering in new areas of research.

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