- Integra LifeSciences (Plainsboro, NJ)
- …all appropriate documentation, drawings, and specifications are generated in compliance with Integra's procedures and statutory requirements. + Initiate, develop ... technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device Manufacture. As required, conduct… more
- J&J Family of Companies (Raritan, NJ)
- …essential for enabling the CARVYKTI network's technical, supply chain, and compliance -related objectives. Collaborating across a complex network of internal and ... aimed at reducing non-conforming product rates, through projects that may/may not require regulatory approval + Provide technical support to regulatory filings, … more
- Lilly (Pleasant Prairie, WI)
- …inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections. + Manage external contracts/resources and ... documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation master plans, protocols and summary reports,… more
- Abbott (Maple Grove, MN)
- …and mock shells, in alignment with the team. + Collaborate with clinical, regulatory , and data management teams to define data checking requirements and resolve ... discrepancies. + Support regulatory submissions, DMC/CEC meetings, IRB packages, and scientific publications with statistical deliverables. + Summarize statistical… more
- Kerry (Beloit, KS)
- …+ Food Safety and Microbiology + Food Chemistry and Process Engineering + Regulatory Compliance and Packaging Science + Proven experience in flavor development ... taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner with customers to...analysis of flavors + Employ thorough knowledge of relevant regulatory requirements for flavors + Work with cross functional… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …* Report, publish, and present HEOR data and study results, ensuring compliance with regulatory standards and effectively communicating evidence to ... and apply insights to pipeline and marketed products, ensuring submissions meet regulatory and payer expectations for value demonstration and reimbursement.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. + Collaborate across Gilead ... Pharmaceutical Development & Manufacturing (PDM) and partner with Quality,...(PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ensure… more
- Insight Global (New York, NY)
- …risk mitigation strategies and documentation. Experience engaging with security, cloud, and compliance teams to ensure all deliverables meet regulatory and ... Job Description One of our largest pharmaceutical customers is seeking a Product Manager Delivery...enablement and administration when necessary (ushering the project through compliance and SDLC). Familiarity with customer security group, cloud,… more
- Catalent Pharma Solutions (Bridgewater, NJ)
- …respect to compliance policies, customer and vendor relations, contract matters, regulatory issues + Assist in merger and acquisition activity + Assist in ... Counsel** will be a member of the Legal and Compliance Department. The **Senior Counsel** will be an important...with a combination of large law firms and/or in-house pharmaceutical experience, required + Individual may be required to… more
- BioFire Diagnostics, LLC. (Lombard, IL)
- …operations in the manufacturing and packaging of prepared culture media for pharmaceutical and food industry customers. This position ensures the safe, efficient, ... + Lead and monitor all 2nd Shift production activities to ensure safety, compliance , and adherence to schedule. + Oversee equipment startups, line changeovers, and… more