Regulatory Information Management Director

SUMMARY/JOB PURPOSE:

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Responsible for enhancing the Veeva Vault RIM Platform to enable the success of stakeholders across the business via collaboration with cross-functional colleagues.

• Responsible for the day-to-day administration, configuration, maintenance, and support of the Veeva Vault RIM Platform in accordance with established Standard Operating Procedures (SOPs).

• ccountable for implementation and delivery of Veeva Regulatory applications to meet business needs aligned with established standards with a focus on regulated functions, including:

• Defines project scope and deliverables to support business goals in collaboration with senior leadership stakeholders.

• Participates in the development of solutions and manage project/change timelines.

• Liaises with key stakeholders to coordinate implementation activities.

• Works with the business to develop additional system and user requirements.

• Defines and oversee documentation of configuration and design specifications.

• Participates in the authoring and execution of implementation plans, user acceptance testing and computerized system validation documentation.

• Conducts data integrity checks/prepare for and support audit and regulatory authority inspection needs; escalate quality or compliance concerns as necessary to study and/or functional leadership

• Drives the development of Regulatory-related documentation: SOPs, WIs, Job Aids and other tools (reference materials, flowcharts, guidances, etc.).

• Analyzes user enhancement requests to deliver solutions focused on establishing and improving business processes that improve efficiency, address process gaps, and enable automation and growth of the organization.

• Clearly and proactively anticipates, identifies, tracks, communicates, and proposes solutions for discrepancies in priorities and plans, prioritize complex and multiple/conflicting responsibilities and/or issues.

• Develops and maintains reports and dashboards to track key regulatory metrics, identify trends and provide insight to stakeholders.

• Provides user training on the Veeva RIM system, troubleshoots issues, addresses user queries and escalates unresolved issues to RIM helpdesk.

• Arranges for just-in-time training or refresher on RIM functionality to help the functional areas successfully complete RIM tasks.

• Helps develop a RIMs Governance structure that will support key decisions and actions around Regulatory for the company.

• Manages the Veeva RIM roadmap by working closely with internal stakeholders and Veeva on the integration of other Veeva Platforms: eTMF, CTMS, QMS - to ensure it meets the business needs.

• Remains current on Veeva Vault RIM updates, patches, and enhancements and developing communications to notify users of any upcoming changes that may impact the users.

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• 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; or,

• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• 9+ years of experience working in a biotech/pharmaceutical or other highly regulated corporate environment, including 5+ year in experience with Regulatory Affairs/Operations, Quality Assurance, and other departments to understand the regulatory needs to be able to configure the RIM system accordingly.

• 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) and industry-wide standards.

• Broad understanding of business processes in a wide variety of functional areas within a large, biotech company, and the ability to translate the needs of those business processes into clear and concise terminology, logical and hierarchical arrangements of system configurations, and clear and effective documentation of those processes.

Knowledge/Skills:

• Develops and manages plans, establishes timelines, sets standards for performance. Proactively balances commitments and overcomes challenges to complete multiple activities and achieve results. Takes pride in delivering high quality work.

• Applies extensive knowledge of the regulatory framework, industry drivers and practices to develop innovative approaches and manage complex work.

• Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one to one situations and effectively presents information to cross-functional groups of colleagues.

• Strong interpersonal skills and ability to accommodate differing views to influence an agreed upon resolution.

• Applies knowledge of organizational goals and objectives and demonstrates advanced skill and insight in gathering, analysing and applying key information to solve problems. Provides regulatory expertise to cross-functional teams. Understands longer term consequences of decisions and actions.

• Effectively leads and manages a team, acting with integrity to build trust and execute on team objectives that contribute to departmental goals.

JOB COMPLEXITY:

• Capable of proactively assessing workload, trends, tasks and priorities for area of responsibility.

• Plans and executes multiple activities.

• Considers alternative methods and contingency plans to avoid potential issues.

• Designs and implements solutions to address project level challenges, taking into consideration the broader impact.

WORKING CONDITIONS:

• Occasional travel may be required.

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.