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Summary:
- 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.
- 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.
- Within BioMarin GRA, the Regulatory Information Management and Technology Team supports a variety of Regulatory Information Management (RIM) tools and processes.
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.
- 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.
Requirements:
- 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:
- 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.
