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Intern, Regulatory Information Management and Technology

Location San Rafael, California Workstyle Hybrid
Who We Are

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.
SUMMARY:
The BioMarin Summer Internship Program will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, while gaining an insight into the pharmaceutical/biotech industry.
BioMarin Global Regulatory Affairs (GRA) is responsible for obtaining approval for new BioMarin products and ensuring that approval is maintained throughout the product lifecycle. GRA serves as the interface between the regulatory authorities and the program teams aiming to ensure that the global project plan correctly anticipates what the regulatory authority will require before approving the product. It is the responsibility of GRA to keep abreast of current global legislation, policies, guidelines and other regulatory intelligence. The RA department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines.
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/PROJECT:
Provide Regulatory Data Management and Regulatory Systems Usage/Implementation assistance for Global Regulatory Affairs RIMT group. Utilizing Information Management skills, provide Business Analysis to assist in enhancing existing Regulatory Information management data quality. 
Envisioned projects include:
  • Assess and reconcile regulatory details associated with Regulatory Health Authority Applications to support both Marketing and Investigational Drug Product authorizations.
  • Preparation of Labeling data for migration into a new system.
  • Providing support for Operational Change Management activities relating to the migration of users from a legacy Regulatory Submissions Viewing platform to an existing/established new Regulatory Submission Archive and Viewing system.
Required Skills:
  • Proficient computer skills and working knowledge of Microsoft Office (Word, Excel, PowerPoint and Outlook)
  • Excellent interpersonal, written and verbal communication skills
  • Strong organizational skills with ability to prioritize and manage tasks in a fast-paced environment.
  • Ability to work independently and collaboratively
Desired Skills:
  • Familiarity with cloud data management systems
  • Ability to analyze, transform, and synthesize data from multiple sources into a single system.
  • Familiarity with Data Visualization and Reporting Concepts
Qualifications/Eligibility:
  • Student pursuing a Bachelor’s Degree in computerized systems or life sciences (or in related fields of study).
  • Student must be returning to school in the Fall Term OR has graduated within the 1 year of the start of the program. 
  • Must be available to work 40 hours a week
  • Must be authorized to work in the United States without visa sponsorship
Benefits of a BioMarin Internship:
  • Apply skills and knowledge learned in the classroom to on-the-job experiences
  • Comprehensive, value-added project(s)
  • Work in teams and with colleagues in a professional environment.
  • Develop skills specific to your major.
  • Opportunities for professional development by building relationships and learning about other parts of the business.
  • Paid company holidays, sick time, and housing/transportation assistance available for eligible employees.  
In the U.S., the hiring range for this position is $ 21.00 to $ 25.00 per hour. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors.
Equal Opportunity Employer/Veterans/Disabled 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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