- Eisai, Inc (Nutley, NJ)
- …role ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study ... clinical operations function, ensuring compliance with GCP and regulatory standards.Develop and implement strategic vision and hands-on operational management… more
- Merck & Co. (Rahway, NJ)
- …of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non- clinical , Clinical , and other functional ... and regulatory postureDemonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC.- Strong experience in safety and environmental… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …US Operations, including but not limited to - Commercial, Patient Services, CMR ( Clinical , Medical, Regulatory ), Finance, and Novo Nordisk global colleagues, to ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Genmab (NJ)
- …synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners ... trial and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety :Participate in definition, review, and approval of data packages… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Partnerships and contracts including vendor outsourcing agreements, PV Agreements (PVAs) and Safety Data Exchange Agreements (SDEAs). Manage oversight of DSI ... with key stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs.Facilitate operational meetings… more
- Genmab (NJ)
- …Working Group (LWG) to develop and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package ... a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading… more
- Merck & Co. (Rahway, NJ)
- …have experience in CDISC SDTM and ADaM standards.Must possess programming expertise with clinical endpoint data (efficacy and safety ) and pharmacokinetic ... data , derived PK parameters).Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH.Ability… more
- Merck & Co. (North Wales, PA)
- …be programmed; an understanding of statistical terminology and concepts Familiarity with clinical data management concepts Experience in CDISC and ADaM standards ... datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing… more
- Merck & Co. (Rahway, NJ)
- …Experience with sterile GMP facility startup.Knowledge of Investigational drug regulatory requirements.Understanding of Clinical Supply Chain Operations.Current ... License:Hazardous Material(s):Required Skills:Applied Engineering, Applied Engineering, Chemical Engineering, Chemistry, Clinical Operations, Customer-Focused, Data -Driven Decision Making, Drug… more
- Merck & Co. (Rahway, NJ)
- …clinical development, as well as process characterization and regulatory filings for successful commercialization.Improve upstream processes by increasing ... achieve our goals, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing, all within a… more
- Insmed Incorporated (San Diego, CA)
- …and procedures suitable for inclusion in IND, NDA, or equivalent regulatory submissions.Must be familiar with BSL-II lab safety requirements.Participate ... ranging from purification development and optimization, process characterization and clinical manufacturing investigation support. As part of this collaborative… more
- Merck & Co. (Rahway, NJ)
- …(API), Chemical Manufacturing, Clinical Manufacturing, Compliance Reviews, Data Analysis, Environment Health and Safety , Interpersonal Relationships, ... enhance performance.Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence.Serve as the primary technical contact… more
- Merck & Co. (Rahway, NJ)
- …robust and scalable upstream processes for biologics in different stages of clinical development, 2) process characterization and regulatory filings for ... To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing… more
- Genmab (NJ)
- …Programming Manager will support the Data Management, Statistics, Drug Safety , Medical, Clinical Pharmacology and Biomarker functions with the above ... of data consistenciesSupports specification and pooling of data across clinical trials within the same...or ethics committees, answers to in-house questions related to data quality, safety monitoring, medical questions etc.Performs… more
- Merck & Co. (North Wales, PA)
- …including data steps, procedures, SAS/MACRO, SAS/GRAPH and programming expertise with clinical endpoint data (efficacy and safety ) and pharmacokinetic ... and programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data , transform the … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Role OverviewThis position will be responsible for metrology support for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with ... to cGMP requirements. This individual will support organization build and ramp-up of clinical production and facility approval of a state of the art cell therapy… more
- Eisai, Inc (Exton, PA)
- …SOPs, and close-out reports for Biologics Pilot Plant campaigns. Support providing data for regulatory documents as required.7. Ensure adherence of operations ... new products in development through their lifecycle (Preclinical through phase III clinical development) at the Biologics Pilot Plant as well as supporting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including ED&AA, IT, Ethics and Compliance, Commercial, Patient Services, CMR ( Clinical , Medical, Regulatory ), Finance, and Novo Nordisk global colleagues. ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Merck & Co. (Rahway, NJ)
- …Skills:Adjuvants, Adjuvants, Animal Vaccination, Chemical Biology, Chemical Engineering, Clinical Chemistry, Data Analysis, Development Projects, Drug ... Oral Formulation Sciences Job Description:Our company's Pharmaceutical Sciences and Clinical Supply (PSCS) organization translates molecules to medicines, working… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systems, and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will ... also provide oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will be responsible… more
