- Insmed Incorporated (NJ)
- …workflows throughout document lifecycles for regulatory documents, including creation, review , approval, revision, distribution, and archival Assist in preparing and ... caregiver support, and flexible work schedules with purposeful in-person collaboration401(k) plan with a competitive company match, annual equity awards, and… more
- Eisai, Inc (Nutley, NJ)
- …according to established design principals and integrates them into the Clinical Development Plan (CDP) and Drug Development Plan (DDP)Leads the development of ... of clinical data.Serves as Medical Monitor (where applicable) to review and monitor study data.Implements strategies to identify, monitor...eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …at Pricing Committee and Pre-PC for aligned accounts/channels and leads review of business case and financial impact scenarios. Ensures appropriate stakeholder ... of SPC Contract Development Responsible for authoring contract templates for legal review and approval. Owns contract development process for aligned accounts -… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …users with workflow handling and electronic system usage.Manage the periodic review process for procedures.Issuance of batch related documentation in support of ... consistent with the safety policies, quality systems and cGMP requirements. Review and approve SOPs, and other documentation.Drive continuous improvement.Have… more
- Insmed Incorporated (NJ)
- …Affairs, CMC, Clinical, Quality) to facilitate document authoring, review , approval, and publishing workflows.Conduct technical checks (validation, bookmarking, ... caregiver support, and flexible work schedules with purposeful in-person collaboration401(k) plan with a competitive company match, annual equity awards, and… more
- Insmed Incorporated (NJ)
- …across the technology portfolioMaintain systems changes, releases, and patches; review system releases and patches for impact across multiple systemsEnsure ... caregiver support, and flexible work schedules with purposeful in-person collaboration401(k) plan with a competitive company match, annual equity awards, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of engineered autologous T cell therapy products.Write and/or review user requirements, functional requirement specifications, qualification protocols, enterprise ... in automation projects from user requirements, design evaluation, specification review through to testing and implementation in a GMP...dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day… more
- Insmed Incorporated (NJ)
- …intern will be assigned goals and objectives that will support the strategic business plan of the company.What You'll Do:In this role, you'll have the opportunity to ... large-scale cyclical HR programs, such as Talent Planning and performance review cycles.Develop a tracking and reporting mechanism for talent/learning program… more
- Insmed Incorporated (NJ)
- …that align with our clinical and commercial objectives. You will author, review , and approve CMC sections of regulatory submissions including INDs, NDAs/MAAs, and ... caregiver support, and flexible work schedules with purposeful in-person collaboration401(k) plan with a competitive company match, annual equity awards, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …or final product samples submitted to the QC laboratories.Perform peer review /approval of laboratory data.Utilize electronic systems (LIMS) for execution and ... documentation of testing.Create, review and approve relevant QC documents, SOP's and WI's.Perform...dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day… more
