- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Novo Nordisk Inc. (Chicago, IL)
- …TA priorities and business needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's directly into the TA head). ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
- Aequor (Newbury Park, CA)
- …deliver training materials and presentations to a global audience. Author/review/approve quality Regulatory Information Management & Systems documents Analysis ... in what we do. Detail oriented, to be able to monitor data quality . Comfortable learning new systems/processes. Someone who is able to follow instructions/guides,… more
- The University of Vermont Health Network (Burlington, VT)
- …the AVP, Chief Regulatory Officer, the UVMHN Coordinator, Accreditation and Regulatory Affairs assists with the implementation of the organizations ... mandated regulatory agency guidelines as appropriate. With the support of the Director , the Regulatory Coordinator is responsible for implementation of key … more
- Merck & Co. (North Wales, PA)
- …divestment and product withdrawal.Support new technology development.Demonstrate an understanding of regulatory affairs and applies this understanding to the ... Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist / Director is responsible for developing and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submissions globally. The Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited to ... areas centered around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory ...and Regulatory operations required.4 or More Years regulatory affairs including filing NDA and sNDA.… more
- Tris Pharma (Monmouth Junction, NJ)
- …planning. The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs , Manufacturing, Quality , etc. to ... individual case reviews, assessment of expectedness and relatedness; Collaborates closely with Regulatory Affairs or appropriate vendors on expedited reports, as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical trials is required Demonstrates technical expertise within Clinical Development, Medical Affairs , and Regulatory Affairs (CMR), staying up-to-date ... the CMR training strategy Ensuring CMR employees receive training on regulatory compliance, quality standards, GxP requirements and industry-specific guidelines… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationships include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs , Regulatory Affairs and other NNI skill areas. ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Affairs , Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs , ... users to define user information needs.Provide informatics project management, SDLC Quality Model expertise, and computer system validation expertise to deliver… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... related to study, project and submission. Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …plans.Partners with and provides subject matter expertise to key internal functions ( regulatory , Quality , Clinical, CMC and formulations, Product Quality , ... visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter. Brief Description:The Director , Toxicology is accountable for managing the global nonclinical … more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …process and ensure compliance with SOPs (Standard Operating Procedures) to produce quality and timely deliverables. In addition, the Director will use ... new ways to solve problems.Collaborate with Biostatistics [clinical and medical affairs ], data science, regulatory , clinical development, medical writing, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …throughout NNI and at external agencies. Key relationships include Marketing, Legal, Regulatory Affairs , and Medical Affairs . Other relationships may ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...to enhance efficiency, when applicable Work with the Medical Director in Medical Affairs for the assigned… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and resource strategies for a VP Function of the Clinical Development, Medical & Regulatory Affairs (CMR) Business Unit. The ideal candidate will possess a ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....a VP Functional area of Clinical Development, Medical & Regulatory Affairs Works with business partners inside… more
- Novo Nordisk Inc. (Miami, FL)
- 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
