- 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)
- …interactions for the drug trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and understands the ... timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx submission… more
- UnitedHealth Group (Lake Success, NY)
- …Facilitates and ensures orientation of personnel Acts as a resource to staff for regulatory and policy matters Ensure strict adherence to Optum Practice, Health ... well with patients, families, teammates, and physicians Recognizes legal and policy limits of individual practice Completes annual evaluations of assigned staff… more
- Genmab (NJ)
- …methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role ... analyses requiring advanced statistical methodologies/techniquesRepresent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or… more
- Merck & Co. (Rahway, NJ)
- …assigned asset(s). Sr. GDMA collaborate with global Commercial, Outcome Research (OR), Policy and Market Access to address opportunities in key countries and engage ... patient care advances. The GDMA coordinates medical affairs activities to resolve regulatory , reputational, ethical, and other asset management issues and is part of… 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
- Cybervance, Inc (Kensington, MD)
- …relationships. Stay current on federal acquisition trends and advise the team on policy or regulatory changes. Maintain a repository of proposal templates, ... required). Deep understanding of the FAR, DFARS, and federal procurement policy . Demonstrated success in developing award-winning proposals. Strong writing, editing,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …requirements.Maintain quality practices in accordance with state and federal regulatory requirements.Strive to reduce non-conformances in supported areas by ... dedicatedly driving compliance.Ensure readiness of records for regulatory inspections and internal audits.Review, compile, and organize batch data.Review, compile,… 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 ... requirements, as well as according to state and federal regulatory requirements.Other duties will be assigned, as the need...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)
- …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
- Genmab (NJ)
- …methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role ... requiring advanced statistical methodologies/techniques Represent the CDT/the company at regulatory meetings, during Key Opinion Leaders meetings, network and/or… 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)
- …journals on clinical quality topics.Build and manage overall relationships with regulatory bodies to address emerging needs and issues.Manage and retain talent ... significant clinical pharmaceutical experience (ie, clinical development or operations, regulatory compliance).Substantial experience in Clinical Quality /CQA conducting a… 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
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… 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
- Rocket Lab Corporation (Long Beach, CA)
- …assemble satellite hardware and software that supports other satellite missions. SENIOR RF REGULATORY LEAD ENGINEER I/II Join our team as the Senior RF Regulatory ... about pioneering advancements in RF engineering and thrive on navigating complex regulatory landscapes, this role is your chance to make a significant impact… 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 ... three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days,...of a diverse and inclusive workforce. It is Legend's policy to ensure equal employment opportunity without discrimination or… 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 ... manufacturingMaintenance, facilities and utilitiesComputerized maintenance management systems (CMMS)EHS and regulatory standards (eg EPA, OSHA and DEA)HVAC operation, building… more
