- Daiichi Sankyo, Inc. (Bernards, NJ)
- …level handles escalated global CSPV case processing issue and handles project . This position prepares trainings, supports CAPA investigations, case review, ... case processing and related CRO/vendor training needs and reviews case processing project specific training materials. Manages and coaches the PV Vendor Training… more
- Merck & Co. (Rahway, NJ)
- …Detail-Oriented, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Interpersonal Relationships, Leading Project ... within our company's Research Laboratories is responsible for developing the drug substance manufacturing processes for our company's biologics pipeline. We work… more
- Eisai, Inc (Nutley, NJ)
- …Utilize compliance systems to support audits and investigations Propose and project manage new system implementations, including vendor selection and onboarding ... and regulations, including: - PhRMA Code - Federal Food, Drug , and Cosmetic Act - Anti-Kickback Statute - False...State Transparency laws - Foreign Corrupt Practices Act Proven project management skills with the ability to prioritize and… more
- Merck & Co. (Lower Gwynedd, PA)
- …the tools and skills to perform job requirements-May participate on project or process improvement teams to drive enhancements-Required Experience & Skills-Strong ... Compliance, Business Administration, Cell-Based Assays, Clinical Testing, Detail-Oriented, Documentations, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Immunoassays,… more
- Insmed Incorporated (San Diego, CA)
- …including, but not limited to, meeting requests, briefing documents, Orphan drug applications, INDs, CTAs, CTNs, and applications for expedited pathways (fast ... industry, preferably with 5+ years of gene therapy orphan (rare) drug development experienceKnowledge or experience of neurology and/or ophthalmology drug… more
- Merck & Co. (Lower Gwynedd, PA)
- …preferably in the vaccines field -Preferred Experience & Skills Project management skills#ProjectADVANCECurrent Employees apply HERE Current Contingent Workers apply ... Testing, Communication, Computer Science, Data Visualization, Detail-Oriented, Discrete Mathematics, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Management… more
- Merck & Co. (Lower Gwynedd, PA)
- …and to adapt to changes in assignments consistent with new or changing project priorities-A knowledge of sample management and maintenance of sample chain of ... Bioanalysis, Biochemistry, Biopharmaceuticals, Biopharmaceutics, Chemical Biology, Communication, Detail-Oriented, Documentations, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Immunochemistry,… more
- Merck & Co. (Lower Gwynedd, PA)
- …Critical Thinking, Delegation of Authority, Detail-Oriented, Documentations, Drug Regulatory Affairs, Employee Training Programs, Global Communications, ... Biology, Molecular Microbiology, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Project Prioritization, Proteomics, Regulatory Affairs… more
- Merck & Co. (Durham, NC)
- …and implement process improvements.This position will support the purification of the drug substance of our vaccine.Responsibilities may include but are not limited ... Associates Degree in science or related field Applicable mechanical and project management experience Proficiency with automated systems (MES, SAP, DeltaV)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …initiatives, asset management, reliability, and business operations.Support facility project initiatives as neededMaintain knowledge of and compliance to ... local, state and federal regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and… more