BioMarin Pharmaceutical
Intern, Regulatory Affairs
PayCompetitive
LocationSan Rafael/California
Employment typeOther
This job is now closed
Job Description
- Req#: o9fsqfw0?nl=1
- Synthesizing/collating cross-functional Stakeholder insights to better characterize and coordinate messaging on unmet need, nonclinical data analysis, and clinical literature to support early drug development in targeted patient populations to gain skills in information synthesis and global regulatory strategic planning.
- Supporting the global regulatory team during dynamic and fast paced global regulatory health authority filings including but not limited to preparation and submissions.
- Working closely with cross-functional Stakeholders to develop strategic messaging and documentation supporting worldwide health authority interactions.
- Advanced knowledge of Microsoft Office Suite
- Strong written communication and information synthesis skills
- Knowledge of basic health sciences
- Basic understanding of drug development pipeline
- Enthusiasm to learn and tackle new projects
- Qualitative and/or quantitative science background
- Intermediate/advanced background in biology or related health sciences
- Bachelors degree in biology or related science field (Health Sciences, Epidemiology, Public Health, Health Research, etc.)
- Student must be returning to school in the Fall Term OR has graduated within the 1 year of the start of the program.u00A0
- Must be available to work 40 hours a week
- Must be authorized to work in the United States without visa sponsorship
- 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 skills specific to your major.
- Opportunities for professional development by building relationships and learning about other parts of the business.
Who We Are
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.BioMarin Global Regulatory Affairs (GRA)u202Fis 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.JOB DESCRIPTION/PROJECT:The Intern position would be working within the Clinical/Nonclinical Regulatory Affairs Early Development team. Responsibilities may include:Required Skills:Desired Skills:Qualifications/Eligibility:Benefits of a BioMarin Internship:In the U.S., the salary range for this position is $ 21.00 to $ 25.00 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.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.About the company
BioMarin Pharmaceutical Inc. is an American biotechnology company headquartered in San Rafael, California.