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Intern, Development Sciences Quality (DSQ)

Location San Rafael, California
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.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development 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 rare diseases. Come join our team and make a meaningful impact on patients’ lives.

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:

The Development Sciences Quality (DSQ) group partners with Development Sciences functional groups, project teams and study teams to promote, facilitate and verify the implementation of, and adherence to, good quality practices across the drug development lifecycle in order to be inspection ready at all times. You will gain hands-on experience in the day-to-day activities within DSQ that are critical to clinical study execution, while also obtaining an understanding of Quality Management activities that support the execution of clinical research and development in a regulated environment. You will be given specific tasks and projects that will result in meeting department goals and improving internal processes.

This position will offer an opportunity to gain exposure in two specific areas of Quality Management – Controlled Documents (i.e. Policy and Procedures) and Records Management (including but not limited to support of Trial Master File processes).  The successful candidate will split their time supporting projects in each area.


Controlled Documents Project:

  • Entry and verification of metadata in a newly implement electronic document management system (EDMS)
  • Develop reports and analyze EDMS activity for trends and possible development of metrics
  • Brainstorm with team to generate and develop creative ideas to manage information and knowledge in the EDMS
  • Develop an understanding for training support for Controlled Documents

Document Management Project:

  • Complete data entry in documentation system
  • Provide documentation system administration support (e.g., document reassignment, tracking user access records)
  • Develop training materials to support system users
  • Support system administrator in system process improvements/upgrades

Qualifications/Eligibility:

To succeed in this internship, you will need Minimum Qualifications: 
Currently pursuing a Bachelor's or Master's degree in a relevant field of study (e.g., Biology, Regulatory Science), with minimum of first/freshman year completed. You should be organized, detail-oriented, and a self-starter with enthusiasm to participate in working meetings. The intern will be provided with an orientation of the role of Quality within Worldwide Research & Development (WWRD). By the end of the internship, the intern will have acquired skills and knowledge that are essential to quality management and will have the satisfaction of a real contribution to processes intended for implement within DevSci Quality. You will give a final presentation to the DSQ department after the internship.

  • Proficiency with MS Office Suite (Word, Excel, PowerPoint, Outlook).
  • 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
  • Housing and Transportation is responsibility of the Intern

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 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

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

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