- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …document disclosure, and data sharing with external researchers. - The Specialist (Disclosure Medical Writer) will be primarily responsible for preparing clinical ... documents for clinical studies in all therapeutic areas. - The Specialist will be responsible for: Authoring scientifically valid clinical trial registration… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QC Microbiology Technical Specialist I/II/III as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QC Microbiology Technical Specialist is an exempt level position with responsibilities for tracking and managing all CAPA's, corrections and change… more
- Eclaro (Berkeley Heights, NJ)
- Clinical Trials Disclosure Specialist Job Number: 24-02719 Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Clinical ... Trials Disclosure Specialist for our client in Madison, NJ. ECLARO's client...Results Specialists, as required Assists in monitoring the global regulatory environment and maintains working knowledge of disclosure requirements… more
- Eclaro (Warren, NJ)
- Commissioning/Qualification Specialist /Specific Commissioning and Validation Support Job Number: 24-03074 Be part of a company that delivers life-changing healthcare ... solutions. ECLARO is looking for a Commissioning/Qualification Specialist /Specific Commissioning and Validation Support for our client in Warren, NJ. ECLARO's client… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of multiple myeloma.Legend Biotech is seeking Environment, Health & Safety (EHS) Sr. Specialist as part of the Technical Operations team based in Raritan, NJ. Role ... OverviewThe Environmental Health and Safety (EHS) Sr. Specialist role is an exempt level position with responsibilities for supporting the Environmental Health and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma.Legend Biotech is seeking a Master Data Governance Sr. Specialist as part of the Technical Operations team based in Raritan, NJ. Role ... OverviewWe are actively seeking a proficient Master Data Governance Sr. Specialist with a specific focus on Materials orchestration throughout the End-to-End… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Operations Inventory Control Specialist as part of the Technical Operations team based in Raritan, New ... Jersey. Role OverviewThe Operations Inventory Control Specialist will be part of the Raritan CAR-T Operations team responsible for building operations activity area… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and compliance with financial and billing processes Familiarity with regulatory compliance, audit processes, and financial controls Excellent communication, ... collaboration, and stakeholder management skills Ability to work autonomously with minimal guidance Pharmaceutical or other regulated industry experience preferred Effective time management skills. Ability to handle multiple projects simultaneously. Strong… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThe QC Technician is responsible for QC sample labelling process. The QC Specialist is encouraged to work independently on routine tasks and have conceptual ... resolve some sophisticated issues. He/ She will serve as technical specialist within job function. Thinks logically and acts decisively.Key Responsibilities Prepare… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Portfolio Foresight Specialist plays a critical role in overseeing the portfolio of assets and indications ... decisions, including market trends, competitive dynamics, patient needs, and regulatory requirements. Stay abreast of industry developments, emerging technologies,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …They will regularly interface with their direct report, the Peer-to-Peer Relations Specialist . This role will regularly collaborate with various parts of the ... enterprise, including Compliance, Regulatory , Omnichannel Engagement, Market Development, Therapeutic Areas/Brands, Experience Intelligence, CMR and Commercial… more
- System One (Somerset, NJ)
- Title: Sr. Compliance and Regulatory Specialist Location: Somerset NJ Schedule M-F 8:30 to 5:00pm On site daily Duration: 3 month contract to hire Education: * ... years of experience working in the pharmaceutical industry in Quality/ Regulatory Compliance, Quality Assurance, Quality Management Systems or associated… more
- Weill Cornell Medical College (New York, NY)
- Title: Regulatory Specialist Location: Upper East Side Org Unit: Geriatrics Administration Work Days: Monday-Friday Weekly Hours: 35.00 Exemption Status: ... Hired for NYC Offices **Position Summary** Oversees the clinical trial regulatory maintenance from study submission through closeout. **Job Responsibilities** +… more
- Integra LifeSciences (Princeton, NJ)
- …are challenging what's possible and making headway to help improve outcomes. The Regulatory Affairs Specialist is responsible for implementing regulatory ... with all current and upcoming regulations in the US and EU. The Regulatory Affairs Specialist is responsible for providing regulatory input for regulatory… more
- Mount Sinai Health System (New York, NY)
- **Job Description** The Quality and Regulatory Specialist facilitates and participates in the implementation of the multidisciplinary hospital and system wide ... who coordinates the planning, monitoring and evaluation of the Quality and Regulatory Readiness program. Participates in planned and unplanned regulatory visit… more
- Catalent Pharma Solutions (Somerset, NJ)
- **Position Summary:** Catalent Pharma Solutions in Somerset, NJ is hiring a Senior Regulatory and Compliance Specialist for the Regulatory Affairs Group. The ... Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to the pharmaceutical industry and their impact on… more
- Bloomberg (New York, NY)
- …when they need it, in the format they prefer. **What's the role?** As a Regulatory Data Sales Specialist , you will be responsible for continuing to grow ... Bloomberg's hugely successful Regulatory Data franchise throughout the Americas market. Over the...the Americas market. Over the years Bloomberg has developed Regulatory & Accounting Products that combine high-quality data, sophisticated… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Sr. CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory ... **A typical day might include the following:** + Reviews regulatory submissions to ensure all aspects of global ...regulatory submissions to ensure all aspects of global regulatory and CMC compliance (beyond GMP compliance) are met… more
- ThermoFisher Scientific (Bridgewater, NJ)
- …**Job Description** **A day in the Life:** + Supervise and lead regulatory compliance for hazardous materials distribution, including DOT, IATA, IMDG, and other ... + Conduct regular audits and inspections to ensure full regulatory compliance and identify areas for improvement. + Train...for improvement. + Train and guide team members on regulatory updates and standard methodologies. + Serve as the… more
