- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Device Development and Commercialization process.Experience with developing and documenting regulatory strategies in coordination with clinical plans and ... diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical Development, RA CMC) to keep processes, procedural ... medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of...centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… 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
- Eisai, Inc (Philadelphia, PA)
- …difference. If this is your profile, we want to hear from you. The Medical Science Liaison (MSL or Sr. MSL) is a field-facing representative of US Medical Affairs ... the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products/pipeline; serve as a conduit for communication between… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- Legend Biotech is seeking Sr. Medical Science Liaison (South Central) as part of the Medical Affairs team based in TN, KY, AR, LA, or MS. Role OverviewAs part of the ... US Medical Affairs team, the Senior Medical Science Liaison (MSL) will be responsible for engaging identified key opinion leaders (KOLs) and other healthcare… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other ... diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …US Operations, including but not limited to - Commercial, Patient Services, CMR ( Clinical , Medical, Regulatory ), Finance, and Novo Nordisk global colleagues, to ... a high-performing organization that:Attracts and cultivates essential skills needed for data science and AI, ensuring the team remains at the forefront of industry… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (ED) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope ... completion of CAPAs. The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across phases in scope of GCTO within… more
- Merck & Co. (Rahway, NJ)
- …there are important interactions with, inter alia , Quality Assurance, Finance, Regulatory , Clinical Supplies and legal in a highly matrix-based organization. ... Job DescriptionThe Regional Head manages all aspects of clinical trial operations in the region and reports...staff members. Education: Required: Master's Degree in a life science combined with a proven track record of contribution… more
- Eisai, Inc (Nutley, NJ)
- …role ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study ... clinical operations function, ensuring compliance with GCP and regulatory standards.Develop and implement strategic vision and hands-on operational management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo. The candidate will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical ... diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... diseases and immune disorders. Job Summary: Assist in planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate… more
- Merck & Co. (Rahway, NJ)
- …and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development ... Engineering or related field plus 5 years SAS programming experience in a clinical trial environmentMS in Computer Science , Statistics, Applied Mathematics, Life… more
- Formation Bio (New York, NY)
- …of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory guidelines. About You Bachelor of Science Degree, as a minimal ... brochures (IBs), clinical summaries and overviews, and clinical study reports (CSRs); regulatory documents (meeting...and overviews, and clinical study reports (CSRs); regulatory documents (meeting and briefing packages, regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and standards. This position ensures quality delivery of laboratory data for clinical trials, clinical development, and regulatory submissions. This ... compliance with the program standards, Policies, SOPs, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory requirements, and other… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Genmab (NJ)
- …or contribute to initiatives that improve operational efficiency, inspection readiness, and regulatory compliance.Act as a Data Standards or Clinical Systems ... compassionate, candid, and purposeful, and our business is innovative and rooted in science . We believe that being proudly authentic and determined to be our best… more
- Tris Pharma (Monmouth Junction, NJ)
- …advanced medical writing expertise and leadership in the preparation of clinical and regulatory documents. Collaborating closely with cross-functional teams ... advancing organization's research objectives and improving patient outcomes.Prepares and reviews clinical and regulatory documents including, but not limited to:… more
