- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for leading global demand ... plans for production, packaging, distribution, and clinical supply budgeting. The Director provides strategic leadership for Clinical Supply Chain & Logistics … more
- Insmed Incorporated (NJ)
- …an 1-2 indications within one compound, in collaboration with the Senior Director , Clinical Operations . Ensures consistent and successful execution of ... time, within budget and with high quality. This role may manage clinical operations team members, as delegated by supervisor, to ensure the effective and efficient… more
- Merck & Co. (Rahway, NJ)
- …Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations , Regulatory ... 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end ...Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for patient support field teams. This role will oversee program operations , compliance, vendor contracts and relationship management. AD will drive collaboration ... privacy, compliance and legal. Relationships The position reports to the Director , Patient Solutions and Field Reimbursement. Closely partners closely with MAPA,… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible for reviewing the CMC post ... approval changes, providing regulatory impact assessments, and coordinating with regional RA-CMC leaders...requirements based on internal technical documents provided by Technical Operations or from CMOs to support development program and… more
- Insmed Incorporated (San Diego, CA)
- …of continuous learning, cross-training, and operational excellence.In partnership with Regulatory Operations , and/or third-party service providers, ensure high ... each other, and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Director , EHS (Environmental, Health, and Safety) isa senior-level role responsible for creating ... and implementing programs that ensure workplace safety, regulatory compliance, and environmental protection for all Insmed locations.Key duties include risk… 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 ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Insmed Incorporated (NJ)
- …broader patient services strategy and organizational goals.This position reports to the Director of Patient Services Operations and will be remote.What You'll ... the future of science, we're in. Are you?About the Role:The Associate Director , Patient Services Quality & Process leads quality assurance and process improvement… more
- Insmed Incorporated (NJ)
- … regulatory requirements while maintaining operational excellence. The Executive Director , Cybersecurity & Risk Management plays a critical leadership role in ... we do. We are seeking an experienced leader to oversee cybersecurity operations , enterprise risk management, and Computer Systems Validation (CSV) program. This role… 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 ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Insmed Incorporated (NJ)
- …clinical projects. Collaborates with cross-functional team members within Biometrics, Clinical Operations , Regulatory , and Clinical Development, as well as with ... future of science, we're in. Are you?About the Role:The Associate Director , Programming provides technical leadership and ensures adequate programming support for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical, Medical and Regulatory more broadly to include NNI and US Operations . This individual will also work closely with global colleagues in Research & ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...you ready to make a difference? The Position The Director , Real World Science leads the evidence strategy and… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Associate Director , Compliance Operations will be a key member of Eisai's US Ethics & ... Salary Transparency Language:The base salary range for the Associate Director , Compliance Operations is from :167,600-220,000Under current guidelines,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …capabilities through strategic vendor partnerships. Relationship This job reports to the Senior Director of the GxP Compliance & Technical Operations . This job ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …scalability, automation, and continuous improvement. Relationships Reports to the Executive Director , PS & GxP Business Operations . Accountable for establishing ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...across US Quality, GxP Compliance Training and Patient Safety Operations . This role ensures that Safety/Quality/Training processes, systems, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programming documentation filed/archived according to applicable Daiichi Sankyo and regulatory requirements.Communicates with Data Operations leadership, asset ... areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management … more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... other teams within BPD and staff in Process Cell Science, US Operations , Clinical Manufacturing, and Commercial Manufacturing groups. The candidate should be capable… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …global quality organization to ensure harmonization, alignment and execution of regulatory guidelines across all manufacturing areas, supporting both clinical and ... initiatives, such as inspection readiness, metrics implementation and review, overall regulatory compliance and implementation programs, and others as required. This… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Summary: -The Associate Director of Device Technology is a key leadership role within the Device Development and Technology Organization. This ... on autoinjectors, prefilled syringes, and other drug delivery systems. The associate director will be a technical subject matter expert on the device components… more
