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Intern - Regulatory Operations

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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. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

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.

JOB DESCRIPTION:

Management of information that is submitted to health authorities:

This is a unique opportunity to learn the types of documents submitted to or correspondence from regulatory agencies worldwide. This position will gain experience with how regulatory documents are managed in a electronic document management system and the importance of maintaining these records in a regulated industry. They will learn about functions across BioMarin and understanding their processes and submission requirements.

This position will assist with data migration activities for a new Document Management System (eDMS) by verifying metadata for documents in existing system is complete and accurate and confirming document migration into the new system was successful. Will provide document management for implementation of the eDMS with metrics and project tracking, working with all Regulatory functional groups and a cross-functional team. May assess procedures needing revision, track and manage those identified, assuring the Regulatory procedure revisions are done in a timely manner by liaising with the Regulatory Business Operations Committee members.

Qualifications/Eligibility:

  • Pursuing a Bachelors’ or Master’s or PhD degree in Biology/life sciences or in a related field of study with minimum of first year completed
  • Pursuing a Master’s degree or certification in Regulatory Affairs or Regulatory Science are preferred
  • Thrives in an environment of cross-functional interaction and collaboration by highlighting interdependencies
  • Good communication skills and well organized. Able to coordinate and work with other departments in a team environment
  • Basic computer skills in Windows 8, MS Office and Adobe Acrobat, able to multi-task and set priorities, work in team environment.
  • Detail oriented and ability to follow instructions and follow through on tasks with consistency, pay close attention to details.
  • Can identify best practices that can be leveraged in solution development
  • Student must be returning to school in the Fall Term OR has graduated within the 1 year of the start of the intern program
  • Must be available to work 40 hours a week

Benefits of a BioMarin Internship:

  • Fully remote/virtual experience; company owned laptop provided for the duration of the internship program.
  • 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 technical skills specific to your major
  • Provides opportunities for professional development by building relationships and learning about other parts of the business
  • Weekly lunch seminar series with Executive Staff
  • End of summer poster presentation to the BioMarin Community

At BioMarin, we are about making a big impact on rare patient populations, and this takes the widest possible range of ideas. To find solutions for the patients we serve, our workforce must represent diversity in all its forms.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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