- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference?The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational ... medicines. You will lead a global regulatory team to...insurance; 401(k) savings plan; flexible spending accounts; employee assistance program ; tuition reimbursement program ; and voluntary benefits… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …may serve as chair of Core Medical Team, at the discretion of the Executive Director Represent NNI Medical Affairs on Global Core Medical Team (CMT) Collaborate ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Medical Director serves as the subject matter expert for our… more
- Merck & Co. (Rahway, NJ)
- …coaching/guidance to individual contributors. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …head). They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical Liaison ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
- Merck & Co. (Rahway, NJ)
- …and other pharmacometric analyses-Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… more
- Merck & Co. (Rahway, NJ)
- …initiatives.Responsibilities:Support the SRO Lead in the execution of extensive, global initiatives, ensuring the program objectives and timelines ... company, the successful applicant will play a critical role in leading major global initiatives aimed at enhancing Medical Affairs practices. The SRO is a recognized… more
- Catalent (Harman, WV)
- Senior Director , Supply Chain Position Summary: The Senior Director , Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain...and objectives related to Supply Chain activities.Work with the global and internal stakeholders to develop and optimize site… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, ... and natural killer (NK) cell-based immunotherapy. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of… more
- Merck & Co. (North Wales, PA)
- …and execution of Phase 1-4 clinical studies. Under the direction of the Program Lead, you will collaborate with global , cross-functional team members including ... trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the… more
- Merck & Co. (Rahway, NJ)
- …carefully designed clinical trials is critical to drug development.The Associate Director , Clinical Trials Communications role within our Research & Development ... enterprise wide (Internal and External) critical communications, focused on our global Clinical Trial efforts.This role is responsible for supporting the… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Represent Device Development… more
- Merck & Co. (Millsboro, DE)
- … inspections (USDA, DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...well as for the veterinary care and animal husbandry program at our company's Millsboro Animal Health facilities. This… more
- Merck & Co. (Rahway, NJ)
- …Data Management, Global Clinical Data Standards Working closely with the Global Clinical Data Standards (GCDS) Sr. Director of Operations and Reference ... Data Management within the Global Data Management & Standards...Management is responsible for the day-to-day oversight of the Program Managers and their deliverables. This includes responsibility for… more
- Insmed Incorporated (Bridgewater, NJ)
- …senior management regarding the potential impact of toxicology results on Program and Clinical/ Regulatory strategy.Author nonclinical sections in regulatory ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Corporate Compliance & Privacy Officer in setting the strategy and program requirements for the Corporate Compliance and Government Accountability Programs. The ... position is responsible for managing and operationalizing the program and team, related to the Ethics, Compliance & Privacy Department's Government Accountability … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Nordisk, you will have the opportunity to build a life-changing career in a global business environment. We encourage our employees to make the most of their talent. ... independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include… more
- Insmed Incorporated (Bridgewater, NJ)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... multiple Research groups. The role will provide scientific and strategic guidance to global project teams and will oversee the internal and CRO resources as they… more
- Insmed Incorporated (Bridgewater, NJ)
- …Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide program level medical oversight of information ... Practices, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies.Must have a global … more
- Insmed Incorporated (Bridgewater, NJ)
- …supply.Review and monitor all lab processes to ensure they follow relevant regulatory GMPs and global company policies & proceduresLead overall management ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality… more
- Insmed Incorporated (Bridgewater, NJ)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of… more
