Regulatory Data Steward

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

About Worldwide Research and Development

From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.

BioMarin Global Regulatory Affairs (GRA) is responsible for obtaining approval for new BioMarin products and ensuring that approval is maintained throughout the product lifecycle. Within BioMarin GRA, the Regulatory Information Management and Technology Team supports a variety of Regulatory Information Management (RIM) tools and processes. Support of the greater Regulatory Affairs department includes stewardship of our Document Management and Regulatory Information Management systems and their related business processes. Some of the business capabilities under our stewardship are providing the tools and processes for managing the production of Regulatory Submission documents, their archival and retrieval, management of Health Authority commitments/correspondence, and maintaining a record of Registrations globally.

**JOB DESCRIPTION**:
The Regulatory Data Steward, is a data quality and management role ensuring Regulatory data is properly managed across the lifecycle of products. Data stewardship includes managing the data accuracy, consistency, and timeliness, plus providing for the connection of the data to other critical systems that utilize such data (e.g., QMS, SAP, etc.).

The incumbent provides Regulatory data management and Regulatory systems usage/implementation assistance for Global Regulatory Affairs RIMT group. Utilizing information management skills with regulatory submissions and registrations expertise to develop rules and processes associated with successful management of regulatory information.

The Data Steward is an empowered, high-level role ushering data into its proper location and lifecycles by coordinating with the data owners. Primarily focusing on Regulatory Registrations data in Veeva RIM, the Data Steward will support reporting capabilities and understand how the data is utilized, provide feedback to System and Business process owners where improvements are needed to ensure high quality data management.

Key Data Steward Role Aspects:

- Data Steward has experience with drug development processes, functional groups, and impacted business units.
- Data Steward has extensive knowledge in the Regulatory requirements of licensed medical products (Pharma) and clinical trials, as well as technical knowledge of systems and tools such as Veeva, SAP, Change Control, to best advise and manage regulatory product information.
- Data Steward has experience working in complex drug development environments with technical teams, such REG CMC, Labeling, Quality, Supply Chain, Contract Manufacturers and ERP team members.
- Experience in organizational change management methodologies is a plus.

**Responsibilities to be included**:

- Management and oversight of Registrations Details, including build out of Registration Record, including master data and operational/transactional data.- Drive ongoing RIM data quality, including:

- Data quality Monitoring
- Ensuring compliance and timely remediation.
- Regulatory Master Data Management & Governance
- Training and Change Management
- Great collaborator across all functions of Global Regulatory Affairs, IT, a variety of Enterprise Stakeholders, and External Vendors.
- A bias for action and a “can do” attitude.
- Attention to detail and ability to reinforce master data rules and processes across the business.

**Required Skills**:

- Working knowledge of Regulatory requirements of licensed medical products (Pharma) and clinical trials. International experience a plus.
- Proficient computer skills and working knowledge of Regulatory Information Management Tools (Veeva Vault RIM STRONGLY preferred), Microsoft Office (Word, Excel, PowerPoint and Outlook), experience with Power BI and SharePoint a plus.
- Excellent interpersonal, written and verbal communication skills. Ability to speak to technical-level staff and develop presentations with level-appropriate messaging up to and including senior level leadership.
- Strong organizational skills with ability to prioritize and manage tasks in a fast-paced environment.
- Ability to work independently and collaboratively
- Understanding of Regulatory Master Data requirements and governance
- Strong analytical, troubleshooting, and problem-solving abilities

*