- Genmab (NJ)
- …portfolio of products. The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be within ... work instructions, templates, and associated documentsThis position may also support regulatory policy and/or intelligence deliverables:Monitor the regulatory… 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)
- … 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for performing a wide range of activities to support the release of CAR-T drug product for human use. This position is responsible for quality and maintaining the ... requirements.Maintain quality practices in accordance with state and federal regulatory requirements.Strive to reduce non-conformances in supported areas by… 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
- 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
- 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
- Merck & Co. (North Wales, PA)
- …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)
- …resulting in the delay of investigation closure and product release.Support regulatory inspections and audits by ensuring inspection readiness within facility and ... serving as an SME during the execution of regulatory inspections and audits as needed.Support compliance activities for...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 a heavily regulated pharmaceutical environment with adherence to strict regulatory guidelines and internal compliance policies.In depth understanding of cleanroom ... early and mature stages of technology development.Thorough knowledge of regulatory requirements such as 21 CFR Parts 210, 211,...three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days,… more
- Eisai, Inc (Nutley, NJ)
- …US FDA, PMDA, ICH, and National regulations).In the current times, drug development is going through a significant transformation with digitalization, utilization ... on clinical quality topics.Build and manage overall relationships with regulatory bodies to address emerging needs and issues.Manage and...equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and… 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)
- …and documented in accordance with all cGMP, company policies, and appropriate regulatory standards.Performs work review, approval and close out of work orders, ... Management knowledge, including Change control, Deviation, and CAPA's.EHS and regulatory standards (eg EPA, OSHA and DEA)Candidate to have...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)
- …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. (San Jose, CA)
- …in a timely manner, submitting expenses, etcReports adverse events to Legend's Drug Safety department and other internal departments as appropriate per required ... with Corporate, PhRMA, and OIG guidelinesStrict compliance with all regulatory agencies, state, and federal law is requiredAdheres to...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)
- …with Quality, Legal, CMC, MSAT, Manufacturing, Supply Chain, and Regulatory to prepare alternate/secondary sourcing strategies.Achieve cost savings objectives for ... of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 US national… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …knowledge of project management discipline and its application to drug product manufacturing required to deliver time, cost, quality, and ... risk management to teams.Experience with Healthy Authority requirements and regulatory submission activities preferred.#DD1#OnsiteThe anticipated base pay range is:$107,482—$141,070… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Global Procedures.Support Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections.Establish key stakeholder relationships with internal and ... of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 US national… more
- Eisai, Inc (Pittsburgh, PA)
- …promotional clinical trials, patient access to medication, and regulatory /compliance guidelines preferred.Experience with account planning and management ... impacting the pharmaceutical industry (eg, PhRMA Code; Federal Food, Drug , Cosmetic Act; Anti-Kickback Statute; False Claims Act, OIG/DOJ...equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and… more
