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.
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