- Merck & Co. (Rahway, NJ)
- …, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our company's ... an effective implementation and oversight model to maintain best-in-industry regulatory compliance.The Vice President Regulatory Affairs ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …matrix team of cross functional partners, including but not limited to: Global Clinical Operations, Global Regulatory Affairs , Biostatistics and Data ... to make recommendations for process improvements - Compliance- Partner with Global Regulatory Affairs to ensure current regulatory requirements are… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …certifications:Preferred Educational Requirements: Preferred Experience: Specialized training/certification in Regulatory Affairs or Clinical Research.Other: ... range of tasks essential to the submission, approval, and maintenance of required regulatory documents for conducting clinical research in compliance with the… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials ... with key functions including discovery sciences, preclinical development groups, toxicology, clinical operations, drug metabolism, regulatory affairs , and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs , Global Safety, Data ... to manage preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program. Relationships The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …East Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic… more
- Merck & Co. (North Wales, PA)
- …and Global Clinical Development (GCD) leaders, and internal stakeholders (eg Global Regulatory Affairs and Clinical Safety [GRACS], Global Clinical ... Job DescriptionActing as Global SME for assigned topics and SOPs, the Global Clinical Development (GCD) Standards & Training Lead (STL) will work closely with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …work closely with cross-functional project teams, including Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs personnel to ... manage preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program. The Director will… more
- 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)
- …and Device Development and Commercialization process.Experience with developing and documenting regulatory strategies in coordination with clinical plans and ... centered around rare diseases and immune disorders. ResponsibilitiesEnsure global regulatory plans support a precision medicine approach eg integrated… more
- Merck & Co. (North Wales, PA)
- …skills- Work Experience Experience/Skills We are Looking for: Minimum:-Bachelor's Degree in Regulatory Affairs , Quality Assurance, Clinical Affairs , ... arena, RDH works with key functional groups within Global Regulatory Affairs , GCTO and others to implement... Affairs , GCTO and others to implement the regulatory strategy for the DHT/SaMD in global clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. ... data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …team in other DSI governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory CM&C and other appropriate ... and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaboration with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. ... data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 30% overnight travel required; Qualifications MD ... About the Department The Clinical , Medical and Regulatory (CMR) department...Affairs , Medical Strategy & Operations, Medical Information, Publications, Clinical Directors, HEOR Directors, Global Medical Directors, Marketing, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders across CDSE and more broadly within Clinical , Medical and Regulatory , Market Access and Public Affairs . Externally, this individual is ... with cross-functional teams, including members of the CDSE team, clinical development, medical affairs , regulatory ,...of the CDSE team, clinical development, medical affairs , regulatory , and commercial, to facilitate the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …that shape decisions and drive organizational action, guide the Business units and the Clinical , Medical, and Regulatory Affairs (CMR) teams on strategy ... with at least eight (8) years of relevant experience required Experience in Clinical , Medical, Regulatory or Research and Development preferred Minimum of three… more
- Eisai, Inc (Nutley, NJ)
- …Director provides strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for ... key business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs and Commercial… more
- Genmab (Princeton, NJ)
- …for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. In this role, you will be primarily responsible ... PhD preferred) Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred) Prior… more
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