Bristol Myers Squibb Digital Capability Manager, Clinical, Regulatory & Medical Operations Capabilities in Hopewell, New Jersey

The Digital Capability Manager, Clinical, Regulatory & Medical Operations Capabilities (DCM, CRMC) is accountable for implementing and supporting strategic information systems to enable Global Regulatory, Safety & Biometrics (GRSB). This role owns end-to-end accountably for managing the implementation, support and maintenance of CRMC technology assets, ensuring they are reliable, accessible, secure, and delivering their intended business value outcomes.

Specific responsibilities :

  • Partners with IT Business Partners to define, plan for, prioritize, deliver, and support strategic digital capabilities to ensure maximum value is achieved.

  • Manages the build and run of technology assets.

  • Defines 3-year digital capability roadmaps in line with business roadmap & enterprise architecture strategy, focusing on speed, quality, & cost.

  • Manages Total Cost of Ownership (build & run) and the key drivers behind them to ensure the digital capabilities are cost efficient.

  • Fulfills all approved, technology asset-specific business needs.

  • Designs technical solutions to satisfy business requirements.

  • Influences vendor roadmaps to align with BMS strategy.

Requirements:

  • Must have related working experience in a highly regulated environment. Prefer minimum 2 years in a Pharmaceutical or Biopharmaceutical environment but open to other regulated industries.

  • Prefer a BS in Science, Engineering, Information Technology or related field but candidate will also consider equivalent relevant work experience

  • Strong practical working experience with Regulatory, nice to have Document Authoring and Dossier Publishing (eCTD) knowledge, with demonstrated command of key concepts, systems and processes.

  • Proven abilities to plan, manage, deliver, and support strategic digital capability programs, from concept initiation through delivery and steady state operations.

  • Support experience in dealing with complex technical issues and working with key business stakeholders to develop and provide solutions for short-term remediation and long-term strategy; collaborating with offshore software developers.

  • Experience in evaluating commercial products (e.g., software packages) and services and influencing the negotiation process for vendor products.

  • Would like to have someone with working knowledge of GxP regulations and delivery of Information Management projects in a GxP environment including SDLC and Agile methodologies.

  • 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.

  • Substantial cross-functional, multi-site, matrix management and team building experience.

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled