Biomarin Open Job Positions
Analyst 1, QC
Novato,
California
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DIVISION: Biomarin - SUMMARY
The Quality Control Analyst I, under direct supervision, is responsible for performing biochemical, physical, and chemical evaluations of QC test samples.
The incumbent will be responsible for performing, under direct supervision, sample testing compliant with cGMP guidelines. This position requires willingness to undergo training on applicable analytical methods and safety policies. Wor .. Show Job Details
Assoc. Director Sr. Manager, Surveillance Risk Management
Novato,
California
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DIVISION: Biomarin - SUMMARY
Leads activities related to, and reporting of issues related to risk management in Pharmacovigilance. This includes the signal detection process for BioMarin marketed products, as well risks in products undergoing clinical development.
RESPONSIBILITIES
• Responsible for participating in or leading the data collection, analysis, review, meeting presentations and follow up of action items .. Show Job Details
Associate 2, Regulatory Operations
Novato,
California
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DIVISION: Biomarin - SUMMARY
This position’s primary focus is the formatting, publishing, transmission and archival of submissions to Regulatory Agencies.
RESPONSIBILITIES
Formatting and Publishing
Able to prepare many filings independently. Provide meaningful feedback to document providers on documents. Some understanding of the projects supported.
Regulatory Intelligence
Intermediate understanding of regulations .. Show Job Details
Associate Director Director, GMP Corporate Compliance
Novato,
California
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DIVISION: Biomarin - SUMMARY
Develop and maintain quality/regulatory compliance programs to assure GMP compliance on a global and corporate-wide level in a rapidly growing biotech company. This position directs compliance staff, all internal and external compliance assessments, product complaint management, GxP training, and is responsible for regulatory inspection coordination and support. This position is also acco .. Show Job Details
Associate Director Director, Reg Affairs
Novato,
California
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DIVISION: Biomarin - SUMMARY
This position helps guide the regulatory strategy of the company, in addition to being responsible for providing leadership and management of all CMC aspects of regulatory affairs.
The role also involves working closely with in-house CMC teams, contract manufacturing organizations, and global health authorities to ensure rapid review and approval of the CMC portions of marketing applicati .. Show Job Details
Associate Director, Global Logistics
Novato,
California
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DIVISION: Biomarin - SUMMARY
Associate Director, Global Logistics will ensure reliable and timely delivery of international and domestic Commercial and Clinical shipments of drug products as well as shipment of raw and intermediate materials. This role will build an infrastructure to effectively manage logistics across a complex supply chain network spanning multiple continents and includes distribution centers, cont .. Show Job Details
Associate Director, Government Affairs
Novato,
California
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DIVISION: Biomarin - RESPONSIBILITIES
The position will have primary responsibility for identifying and analyzing and, influencing Federal state and local legislative and governmental policy issues affecting BioMarin. Specific duties will include:
- analyzing and summarizing emerging legislative matters and briefing senior management on pending matters;
- liaising with industry organizations, including BIO and CHI;
- .. Show Job Details
Associate Director, Medical Writing
Novato,
California
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DIVISION: Biomarin - SUMMARY
The Associate Director of Medical Writing has administrative and functional oversight responsibilities for Medical Writing staff and is responsible for departmental resource planning, contributes to submission planning for program and product development, represents Medical Writing in communications with regulatory agencies, and may participate in review and approval of regulatory submiss .. Show Job Details
Associate Director, Regulatory Affairs
Novato,
California
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DIVISION: Biomarin - SUMMARY
This position will be responsible for:
1. Providing regulatory guidance and oversight of advertising/promotion (Ad/Prom), and global labeling activities for all BioMarin products
2. Providing regulatory guidance to development teams on the clinical design requirements to support proposed promotional and labeling claims
3. Tracking and implementing FDA policies, guidelines and guidances
4. .. Show Job Details
Associate Director, Supply Chain Planning
Novato,
California
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DIVISION: Biomarin - SUMMARY
The Associate Director, Supply Chain Planning will lead the Commercial and Clinical Supply Chain teams to ensure reliable product supply to a global patient population. The Commercial Planning team is responsible for converting product forecasts, developed in partnership with Commercial and/or Clinical, into proactive production plans that incorporate effective contingencies for appropria .. Show Job Details
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