- Merck & Co. (North Wales, PA)
- …selected individual will function with a high degree of independence and provide regulatory oversight for assigned products, in order to optimize label and ... Job DescriptionThe Director , Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory Operations is ... The Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited to original NDA/BLA/MAA,IND/CTA,… more
- Eisai, Inc (NJ)
- …components of overall medical operating plan. The Medical Director provides strategic development, planning, implementation and oversight ... If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs strategy, planning and… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive ... tactics for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working with key stakeholders to develop… more
- Tris Pharma (Monmouth Junction, NJ)
- …immediate opening in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director , Clinical Operations provides expert ... Clinical Project Managers, Clinical Trial Managers, Clinical Data Managers, Regulatory Managers, Medical and Safety Managers, Biostatisticians, Medical Writers, etc.… more
- Eisai, Inc (Nutley, NJ)
- …components of overall medical operating plan.The Sr Medical Director provides strategic development, planning, implementation, and oversight ... this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to the ... of clinical outsourcing marketplace and industry trends.Participate in supplier oversight and governance meetings and lead processes improvement initiatives as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory agencies. Supervise designated personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager ... 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
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Director , Digital Innovation and Omnichannel Engagement will be responsible for the direction and ... and drive best practices within Scientific Communications and Medical Affairs.Drive oversight , project management and delivery of digital initiatives.Partner with IT… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth ... knowledge of regulatory authority's requirements.Typically has administrative responsibility for recruiting, retaining, developing, and managing employees. Guide… more
- Merck & Co. (North Wales, PA)
- … regulatory filings.our Technical CMC teams for end-to-end Quality oversight /support of New Modalities products.Support development of and report quality metrics ... is responsible for supporting the implementation of a unique quality oversight model necessary to facilitate agility and speed-to-market while ensuring sustained… more
- Merck & Co. (Millsboro, DE)
- …Delaware seeks to add an Attending Veterinarian in the role of Associate Director .This position will have overall responsibility for oversight and administration ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...care and use of animals.Responsibilities also include training and oversight of the animal care staff, serving as a… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- …end-to-end GMP clinical supply manufacture and product/process development, as well as oversight of the Enterprise Resource Planning systems (SAP, PAS-x) and the ... compliance councils. Key performance indicators range from quality and regulatory compliance, operational excellence, pipeline program support, financial, talent… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical ... Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction… more
- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning, ... coordinating and prioritizing activities of the product safety team and providing oversight of Pharmacovigilance (PV) vendors in all aspects of PV activities for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has leadership and ... overall strategic oversight of study management and delivery for all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of ... providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. This position may propose strategies for external data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …OR rep licensure), NNI government agreements (eg Corporate Integrity Agreement (CIA)) regulatory requirements (eg PDMA reporting) and the systems that support these ... Supports North America and serves on global projects. Provides guidance and oversight to team members as requested. Essential Functions Supports the Corporate… more
