Director/Sr Director Regulatory Information Management & Technology
Director/Sr Director Regulatory Information Management & Technology
Department / Cost Center:
GRA Global Labeling and Operations
Reports to (Job Title):
OVERVIEW: BioMarin Regulatory Affairs
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
The Director/Senior Director heads the Global Regulatory Information Management & Technology (RIMT) function. Key areas of responsibility include business process owner and oversight RIM systems including document management and registration systems and leading Regulatory Informatics and technology. The Sr Director is a strong leader with Information Technology and Regulatory business process expertise with pharmaceutical and biotechnology regulatory knowledge to drive the ongoing transformation and continuous improvement within GRA. This role is a strategic partner to the Reg Operations, Reg Leadership Team, and other key GRA partners. This is done in partnership and close collaboration with Information Management, TOPS and R&D organizations. As a strategic partner, the role will be a key champion and change agent at all levels of the organization. This role is accountable for process, information and technology initiatives that maintain compliant operations within GRA as well as modernize workflow and business practices for these capabilities. The role will influence future processes, information management and technology evolutions, ensuring continuous improvement advances within GRA and with key partners. This role may chair or represent GRA on a selected cross-functional working groups or governance committees.
- Provide the leadership and direction to the RIMT and Reg Informatics teams to ensure GRA performance is optimized.
- Execution of a holistic action plan for GRA operational activities, to promote end-to-end thinking working with business stakeholders to streamline the way we work, and to leverage data and business insights to actively monitor and continuously improve GRA processes to drive flawless execution and manage risk through use of technology and systems.
- Creates and manages technology capability strategy and roadmap for GRA, aligned to the Company business objectives and with the IM corporate strategy.
- Ensures compliance, audit readiness and operational stability of the Global Regulatory Affairs application landscape.
- Advises and influences senior management on the marketplace evolution and potential application of information and technology and business processes aligned to the overall GRA strategy.
- Builds superior skills within the strong overall team, performance management, talent development for his/her area of responsibility.
- Addresses complex problems with broad implications for process and technology, balancing the often competing needs of standardization and innovation to support a highly effective GRA department.
- Makes decisions regarding resource alignment/dedication and prioritization (people resources, dollars/funding, project criticality) and communicates rationale.
- In close partnership with senior business stakeholders, manages GRA RIMT related governance processes and resources, and will consistently influence, match and prioritize complex demands on multiple services to maximize value to the business and operational excellence within GRA.
- Represents Company in relevant industry groups.
- Manage vendors and contractors as applicable to systems and technology project(s).
Veeva Vault (RIM) Governance
- Serve as the Veeva Vault Business Process Owner including setting the vision, schedule, outcomes and accountability for this system and processes.
- Govern the change request process.
- Leads and guides the Regulatory Information Management (RIM) team tasked to create a sustainable, trusted, and scalable environment for managing regulatory information globally.
- Represent the registration tracking project and provide other updates at other leadership teams.
- Understand and approve the project work streams strategies/approaches including process, build, testing, migration, change management, training, and deployment.
- Make final recommendation at the project level including recommendation on what should be put into a future release.
- Ensure data quality processes controls are built into the project.
- Ensure the needs at the GRA corporate and local level are addressed as well as cross functional stakeholders that work within the RIM system.
- Reinforce program objectives and messaging to ensure on-going compliance and utilization.
- Review and approve deployment plan and hypercare approach.
- Review and approve long term support plan and training needs.
- Translate global RIM-related regulations into meaningful business requirements and solid action plans to support current and future RIM initiatives over the next 3-5 years.
- Oversee the Reg Informatics function supporting technology and tech projects within the department.
- Champion innovation and challenge “the way it has always been done” approaches.
- Lead a team of Subject Matter Experts in RIM technologies and serve as a GRA business process expert.
- Represent GRA in technology governance forums and address new tech requests and changes to existing systems.
- Liaise with internal stakeholders and IM, on behalf of GRA, to prioritize, communicate, and continually manage new technology projects, or changes to existing systems; represent GRA on the key internal technology decision making forums.
- Educate internal business partners and coop their support and advocacy of GRA technology planning and governance.
- Support other GRA technology needs such as management of the department internal website as a resource for Regulatory Affairs.
- Provides leadership and subject matter expertise on Regulatory systems projects.
- Responsible for the execution and delivery of Regulatory systems projects (new implementations, mergers, upgrades, and enhancements).
The Sr Director is expected to exhibit mastery-level competence in Global Regulatory Affairs core competencies in the areas of RIM and Technology. Key attributes include excellent communication and collaboration, ability to adapt to changing business needs and technological advancements with advanced competence in leadership, strategic planning and problem solving.
- Prior demonstrated experience leading process and technology projects in Regulatory.
- Experience with VEEVA and/or RIM Vault, or other document management and registration tracking systems.
- Experience with Office 365 a plus
- Understanding of validated systems and regulatory requirements
- Demonstrated ability to establish effective working relationships in different functions
- Strong organization and communication skills within a matrixed organization
- Demonstrated ability to effectively influence leaders and team members
- Recognizes cross-functional, company-wide, or vendor-based impact of issues and opportunities and appropriately considers input and implications in solution development
BioMarin offers comprehensive career development programming, including guidance, targeted training opportunities, and mentorship programming. A career development pathway for Medical Affairs has been defined and is available to employees of BioMarin.
The position may manage several direct reports and management of contractors; actual number of direct reports may vary depending on business needs
EDUCATION AND EXPERIENCE
- BA/BS or higher in business, life or health sciences or technology.
- 10-15 experience, with experience in the pharmaceutical industry specifically with regulatory systems and technology.
- 10 years of relevant experience in Regulatory Affairs or equivalent
- Management of cross functional teams