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Internship

Intern, Regulatory Information Management and Technology

🚀 Summer Internship

San Rafael

AI generated summary

  • Proficient in Microsoft Office, strong communication and organizational skills, ability to work independently and collaboratively. Familiarity with cloud data management systems, ability to analyze and synthesize data, and knowledge of data visualization concepts. Pursuing a Bachelor’s Degree in computerized systems or life sciences, returning to school in the Fall Term or graduated within the past year. Available to work full-time and authorized to work in the United States.
  • The intern will support Global Regulatory Affairs by providing data management assistance, conducting business analysis to improve data quality, reconciling regulatory details, preparing labeling data for system migration, and assisting with operational change management activities.

Summer Internship

IT & CybersecuritySan Rafael

Description

  • 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. 

Requirements

  • 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

Education requirements

Currently Studying

Area of Responsibilities

IT & Cybersecurity

Responsibilities

  • 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.

Details

Work type

Full time

Work mode

hybrid

Location

San Rafael