Regulatory Information Management Director

Exelixis • King of Prussia, PA

231d • $174,500 - $248,000

About The Position

The Regulatory Information Management Director performs a technical role in Regulatory Operations that is responsible for managing and maintaining the Veeva Regulatory Information Management (RIM) system. Some of the technical responsibilities include ensuring data integrity, user access control, system configuration and compliance with regulatory standards by overseeing user accounts, workflows, data quality and system updates, while collaborating with cross-functional teams to optimize regulatory processes within the Veeva platform. This technical role requires a Veeva expert with cross vault applications that drives the successful development and implementation of enhanced features, technical improvements and system releases for Veeva RIMs.

Requirements

• Bachelor's degree in related discipline and a minimum of thirteen years of related experience; or, Master's degree in related discipline and a minimum of eleven years of related experience; or, PhD degree in related discipline and a minimum of eight years of related experience.
• 9+ years of experience working in a biotech/pharmaceutical or other highly regulated corporate environment.
• 5+ years of experience with Regulatory Affairs/Operations, Quality Assurance.
• Experience with system implementation, upgrades and change management processes.
• Proven experience with Veeva Vault RIM system administration and configuration.
• Proficiency in data management practices, including data validation and cleansing.
• Experienced with regulatory standards (e.g., 21CFR Part 11, ICH-E3, ICH-E6, eCTD).
• Broad understanding of business processes in a wide variety of functional areas within a large, biotech company.

Nice To Haves

• Strong interpersonal skills and ability to accommodate differing views to influence an agreed upon resolution.
• Demonstrates clear and effective verbal and written communication.
• Ability to proactively balance commitments and overcome challenges to complete multiple activities.

Responsibilities

• Enhance the Veeva Vault RIM Platform to enable the success of stakeholders across the business via collaboration with cross-functional colleagues.
• Administer, configure, maintain, and support the Veeva Vault RIM Platform in accordance with established Standard Operating Procedures (SOPs).
• Implement and deliver Veeva Regulatory applications to meet business needs aligned with established standards with a focus on regulated functions.
• Define project scope and deliverables to support business goals in collaboration with senior leadership stakeholders.
• Participate in the development of solutions and manage project/change timelines.
• Liaise with key stakeholders to coordinate implementation activities.
• Work with the business to develop additional system and user requirements.
• Define and oversee documentation of configuration and design specifications.
• Participate in the authoring and execution of implementation plans, user acceptance testing and computerized system validation documentation.
• Conduct data integrity checks and prepare for and support audit and regulatory authority inspection needs.
• Drive the development of Regulatory-related documentation: SOPs, WIs, Job Aids and other tools.
• Analyze user enhancement requests to deliver solutions focused on improving business processes.
• Develop and maintain reports and dashboards to track key regulatory metrics.
• Provide user training on the Veeva RIM system, troubleshoot issues, and address user queries.
• Help develop a RIMs Governance structure that will support key decisions and actions around Regulatory for the company.
• Manage the Veeva RIM roadmap by working closely with internal stakeholders and Veeva.
• Remain current on Veeva Vault RIM updates, patches, and enhancements.

Benefits

• 401k plan with generous company contributions.
• Group medical, dental and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program.
• Opportunity to purchase company stock.
• Long-term incentives.
• 15 accrued vacation days in the first year.
• 17 paid holidays including a company-wide winter shutdown in December.
• Up to 10 sick days throughout the calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree