- Merck & Co. (North Wales, PA)
- Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist / Director is responsible for developing and ... implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project team.Experience in regulatory compliance expectations across all phases of product development to ... a range of modalities including small molecules and peptides.- Within OFS, the Director will influence the strategy, lead activities, and develop a team whose roles… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …based on potential impact on product quality, patient safety, and regulatory compliance . Address recurring deviations and health authorities' observations ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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...development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to… more
- Eisai, Inc (Nutley, NJ)
- …customer journeys and strategies across target audiences as well as ensure regulatory /legal and compliance requirements are met.This role requires strong ... If this is your profile, we want to hear from you. The Associate Director , Omnichannel Marketing and Media position reports to the Senior Director , Omnichannel… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the CMR training strategy Ensuring CMR employees receive training on regulatory compliance , quality standards, GxP requirements and industry-specific guidelines ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Insmed Incorporated (Bridgewater, NJ)
- …different therapeutic areas, ensuring alignment with company objectives and in compliance with regulatory guidelines and industry standards.Provide scientific ... discipline. DABT/DACVP certification preferred.Minimum of 15 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Manage and oversee all assigned projects/products/processes. Assist the Director /Associate Director in assuring Novo Nordisk compliance with internal SOPs ... regulatory agencies. Supervise designated personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are currently recruiting for a Director of Global Oncology Marketing to join a dynamic area of the business supporting the Disease Area Strategies ... for Melanoma.Reporting to the Global Disease Lead for Skin Cancers, The Director of Global Oncology Marketing - Melanoma provides the opportunity to lead our… more
- Eisai, Inc (Nutley, NJ)
- …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 ... communication/publication components of overall medical operating plan.The Sr Medical Director provides strategic development, planning, implementation, and oversight of… 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 ... and functional service providers for Eisai's R&D functions. This role will ensure compliance with key processes and manage the outsourcing team. The ideal individual… more
- Tris Pharma (Monmouth Junction, NJ)
- …Organizations (CROs) and vendors across all phases of drug development; Ensures compliance with established clinical and regulatory guidelines, operating systems ... immediate opening in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director , Clinical Operations provides expert… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ROI, KPI, financial milestones and related payment schedules) Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Merck & Co. (Millsboro, DE)
- …and unregulated species including chickens, turkeys, dogs, cats, rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...company's Millsboro Animal Health facilities. This role is highly compliance -driven in accordance with State and Federal regulations as… more
- Eisai, Inc (Nutley, NJ)
- …digital initiatives within budget and adhering to digital governance, legal, compliance and regulatory standards. Requirements Bachelors in science or ... 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… more
- Merck & Co. (North Wales, PA)
- …teams in order to build partnerships and trust with Commercial Legal, Compliance , Privacy and Regulatory colleagues to effectively alleviate concerns and ... work model (combination of in-office and work from home abilities).The-Associate Director , Digital & Omnichannel Innovation for US Oncology-focuses on digital health… more
- Merck & Co. (Rahway, NJ)
- …compliance councils. Key performance indicators range from quality and regulatory compliance , operational excellence, pipeline program support, financial, ... includes operating model, culture, talent development, technology introduction, and compliance .- However, one co-lead remains focused on non-sterile pipeline… 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. (Rahway, NJ)
- …to continue advancing medical innovation and improve lives. Position Description:- The Director - International Tax will report directly to the Director , ... not limited to:Responsible for preparation and review of US international tax compliance forms and disclosures (Forms 5471, 8858, 8865, 1118, 8991, 8992,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … task forces, who's goal is to assess impact and oversee the company's compliance with new and changed regulatory obligations related to Corporate Compliance ... is required. A minimum of 10+ years combined pharmaceutical, legal, regulatory , and compliance experience required Or a minimum of 8 years experience if… more
