- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of… more
- Legend Biotech USA, Inc. (Charlotte, NC)
- …groups.The CTCE is responsible for conducting all activities in accordance with current regulatory and health care compliance guidelines and in alignment with ... operating company labeled scientific data; market dynamics and competitive landscape; regulatory and health care compliance guidelines; corporate policies on… more
- Merck & Co. (Rahway, NJ)
- …clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be ... studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical … more
- Merck & Co. (Rahway, NJ)
- …analysis, regulatory filing, and publication. - Specifically, The Executive Clinical Director may be responsible for: Evaluating pre- clinical and ... Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Genmab (Plainsboro, NJ)
- …and ensure effective team planning. Regulatory and Audit ComplianceEnsure compliance with country-specific clinical supply regulations.Represent GCDS during ... to fulfilling our purpose.The RoleGenmab is searching for an experienced Director, Global Clinical Drug Supply to be part of Global Clinical Drug Supply… more
- Genmab (Plainsboro, NJ)
- …strategic cross functional collaboration (ie, project/program and trialsLead/Participate in Clinical Project Supply Team discussionParticipate in regulatory ... is essential to fulfilling our purpose.Genmab is seeking a Clinical Drug Supply Manager to join our Global ...drug supply plan, milestone tracking, IMP manual, etc.Ensure GxP compliance & regulatory guideline compliance … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... regulatory labeling-related activities. Updates internal processes to ensure compliance with health authority requirements and expectation Physical Requirements… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disorders. Job Summary: The incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good Clinical ... operational planning and execution at the study level with responsibility for clinical study plan and execution (from planning start-up, conduct, reporting and close… more
- Merck & Co. (Lower Gwynedd, PA)
- …(eg, neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility ... activities and all other associated Quality functionsUnderstands and applies regulatory / compliance requirements relative to their role.Experience working within… more
- Merck & Co. (Rockville, MD)
- …overall company position to respond to upcoming legislation, guidance, and regulatory processes applying to clinical evidence development.-Working closely with ... clinical research policy goals.Working closely with the Global Regulatory Policy team to align on clinical ...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- … regulatory requirements, the competitive landscape, and commercial considerations.Planning clinical trials (design, operational plans, settings) based on these ... Job DescriptionOur Clinical Development teams manage studies to provide the...to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications… more
- Merck & Co. (Rahway, NJ)
- … development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible ... studies;Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical … more
- Merck & Co. (Rahway, NJ)
- … clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. - Specifically, the Senior Director may be ... Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Merck & Co. (Rahway, NJ)
- … development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Key Functions: Specific ResponsibilitiesEvaluating pre- ... studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical … more
- Merck & Co. (Rahway, NJ)
- …to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical ... Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Merck & Co. (Rahway, NJ)
- …in the external community (Key Scientific Leaders, Patient Community, Payers, Regulatory Agencies)Responsible for managing, coaching, and mentoring Clinical ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Respiratory will focus on driving strategy, development, and life-cycle… more
- Merck & Co. (Rahway, NJ)
- …in the external community (Scientific Leaders, Patient Community, Payers, Regulatory Agencies)Responsible for managing, coaching, and mentoring Clinical ... Head in the Atherosclerosis & Metabolism Therapeutic Area within Global Clinical Development will focus on driving strategy, development, and life-cycle management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production of autologous CAR-T products for ... clinical trials and commercial operation in a controlled cGMP...independent audits; manage audit responses and observation resolution.Drive site compliance to regulatory , enterprise, and global requirements… more
- Merck & Co. (North Wales, PA)
- …strategies, processes, and systems for a pharmaceutical company, ensuring compliance with regulatory requirements and maintaining high-quality standards.- ... regulatory requirements and ensure patient safety, quality and compliance .-Oversee PV processes: Responsible for overseeing all PV processes, including adverse… more
