- Genmab (NJ)
- … drug development pertaining to statisticsExperience with the relevant regulatory requirements for biostatistics processes and SOPsExperience with regulatory ... scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for the drug trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and understands the competitive ... drug development and commercialization.Ability to navigate evolving CDx-relevant regulatory guidelines and provide guidance and mentorship to junior CDx… more
- Genmab (NJ)
- …scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation ... and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role modelEnsures consistency of statistical methods and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …member of the Technical Operations team, responsible for ensuring adherence to regulatory requirements and internal quality standards across cell and gene therapy ... continuous improvement.The Compliance Auditor will conduct internal audits, support regulatory inspections, and lead investigations to ensure process integrity and… more
- Merck & Co. (Rahway, NJ)
- …that include coordinating the activities of a programming team.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project portfolio and prioritize and drive projects from inception through regulatory approval to global implementation.Requirements BS required, Ph.D. preferred in ... network and drive change management process from inception through regulatory approval to global site implementation.Candidate must have extensive experience… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …thermal energy principals, mechanical maintenance techniques, and electromechanical theoryEnsures regulatory and job training remains current by promptly completing ... local, state and federal regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will include but not limited to tasks mentioned above.Support regulatory inspections and audits as needed.Consistently perform tasks in adherence ... and cGMP requirements, as well as according to state and federal regulatory requirements.Other duties will be assigned, as the need arises.Job duties performed… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various ... talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and other...three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in driving consistent statistical approaches and defending them to regulatory authorities is desirableExperience in collaborating with internal technical SMEs ... comparabilityIndustry leading knowledge in technology transfer, process comparability, CMC regulatory guidelines and manufacturing in cell therapyAbility to think… more
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