Bristol Myers Squibb Regulatory Global IT Operations DCM for Veeva RIMS in Princeton, New Jersey

Responsibilities:

Regulatory Global IT Operations DCM for Veeva RIMS

  • Accountable for directing and leading the global IT operations of the Veeva Regulatory RIMS platform and IT support activities across the Regulatory organization at BMS.

  • Collaborate closely with the Regulatory business organization from a business relationship lead perspective and serve as the resident expert in the Enterprise Veeva IT Operations team at BMS on the following business processes supported by the Regulatory RIMS system: Critical Submission Planning and Tracking, Marketed Products Planning and Tracking, Investigational Products

  • Serve as the Regulatory IT Lead and primary interface between business partners and technology vendors on demand management projects in order to analyze and validate published business requirements and turn them into functional solutions.

  • Direct and Lead across multiple regional and global teams to ensure harmonization of global/regional Release Management of the Regulatory RIMS system.

  • Establish and direct a strong working relationship with the IT Plan team in the Regulatory domain to participate in the development of a roadmap aligned with portfolio planning.

  • Work closely with strategic partners, providing the leadership necessary to synchronize business and IT Enterprise Veeva processes and ensure compliance with BMS policies and procedures.

  • Partner with Veeva to define additional Veeva opportunities at BMS and drive those opportunities to the platform, further enabling the Enterprise Veeva Platform model.

  • Serve as the primary Operations Lead in Regulatory IT to business partners and technology vendors to discuss their business needs and explore advancement of solutions with vendors depending on current and future needs.

  • Lead and work closely with matrix teams from BMS and external vendors to ensure a smooth execution of support and demand management project activities.

  • Manage a team of 8 people: 4 US based resources and 4 offshore resources, all outsourced operations analysts, testers and multiple vendor teams to execute on Veeva RIM demand management projects and release management.

  • Partner with IT Business Partner teams to develop road maps and identity investment opportunities to deliver new solutions

Life Cycle Management

  • Manage and oversee operational financial budget 3 – 3.5 million annually. Take full ownership of and manage software license usage to ensure 100% compliance with contracted software license agreements.

  • Accountable to ensure that all budgetary targets are met or exceeded, and where possible identify and pursue further opportunities for savings or cost avoidance by utilizing automation and AI methodologies.

  • Drive business performance through a highly effective and efficient demand management & release management process, delivering on all commitments.

  • Ensure the demand management process develops a fully aligned and business-approved demand management portfolio per incremental release cycle, building more structured, strategic, and aligned relationships with business constituents in Regulatory.

  • Serve as the resident IT Lead to provide oversight to Accenture and Veeva in the Regulatory space to ensure delivery of business-approved Operational portfolio commitments, critical releases, and other approved changes according to agreed time, budget, scope and quality.

  • Ensure direct compliance with defined SDLC practices. Deliver on time, on scope, on budget, and with all requisite qualifications per SDLC.

  • Drive business performance through delivering operations activities related to application and business operations support for the Regulatory RIMS system.

  • Ensure effective change control leadership around the review and approval of change requests related to the Regulatory RIMS system.

  • Ensure full and timely IT support to progress critical pipeline activities (ie., critical study filings, FDA submissions, String of Pearls acquisitions, divestitures), ensuring effective collaboration and coordination.

Compliance

  • Take full accountability and ownership in the support of internal and health authority audits by representing IT as single point-of-contact for compliance-related matters (e.g., regulatory agency compliance audits, Corrective Action / Preventive Actions).

  • Fully accountable to ensure health authority and internal regulatory compliance and quality practices are met or exceeded.

  • Ensure compliance with SDLC standards and ensure quality deliverables for maintenance activities.

  • Directly lead and ensure timely IT coordination and support to address 100% of audit findings in accordance with agreed-upon time-lines.

Requirements:

  • Bachelor’s degree in Computer Science, Information Technology, or related field, is required.

  • Overall 10-15 years in Information Technology with 8-10 years of pharmaceutical experience or other relevant Vault and Regulatory processes

  • Experience in Regulatory systems specifically Veeva RIMS is very desirable

  • Strong leadership and decision making skills, with the ability to influence others

  • Proven strong client management skills particularly with senior level

  • Ability to effectively manage multiple, complex initiatives and conflicting priorities

  • Strong written and communication skills

  • Demonstrated ability to build strong working relationships with a broad matrix team and ability to influence others and achieve results

  • Excellent business and transaction processing skills

  • Strong analytical and problem solving skills

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.