Intern, Regulatory Information Management and Technology

Description

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.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

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. 

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. Over the course of 10 – 12 weeks our interns gain industry experience while working alongside our talented team on meaningful projects.

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.
• Providing support for Operational Change Management activities relating to technology improvements related to the Veeva RIM platform.

Required Skills: 

• Knowledge of the Regulatory Affairs submission process
• 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).
• Must be available to work full time, 40 hours a week.
• Must be currently enrolled as a full-time student at an accredited U.S. based university or college and enrolled in the fall term after the completion of the internship OR have graduated within 1 year of the start of the program.
• Must be able to relocate if necessary and work at the designated site for the duration of the internship for on-site, hybrid roles.

Benefits of a BioMarin Internship: 

• Paid hourly wage, paid company holidays, and sick time
• Apply skills and knowledge learned in the classroom to on-the-job experiences
• Comprehensive, value-added project(s)
• Develop skills specific to your major.
• Opportunities for professional development by building relationships and learning about other parts of the business.
• Participate in company all hands meetings, monthly community lunches
• Corporate office amenities such as: 24/7 on-site gym, coffee truck, snacks
• Access to Employee Resource Groups
• Assistance with housing/transportation to help alleviate costs associated with the internship for eligible employees.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

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.

In the U.S., the salary range for this position is $ 21 to $25 per hour, which factors in various geographic regions. 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.

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