- Merck & Co. (Rahway, NJ)
- …visualization.Interacts with people with diverse background and expertise, including research scientists, clinical scientists, regulatory experts, IT ... queries relating to study design, analysis, and interpretation posed by the research scientists, clinical scientists, and regulatory agencies.--Is involved in … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: This role is ... responsible for providing regulatory strategic and tactical leadership, and alignment to ways of working on assets which are subject to an Alliance. This role will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary This role offers ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Merck & Co. (North Wales, PA)
- …and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional ... practices are consistent with regulatory guidelines, our company's policies, and support business objectives.Serve as the liaison and manages correspondence with… more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The RoleGenmab is looking for an Associate Director, Global Regulatory Affairs, Regulatory Strategy to be a part of our Global ... Regulatory Affairs organization.In this role, you will work in...has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a… more
- Genmab (Plainsboro, NJ)
- …for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be primarily ... responsible for the development of global (and US) regulatory strategies (depending on the assigned project/projects) to advance Genmab's portfolio of development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Associate ... Director of Regulatory Writing is a key role responsible for producing...key role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines.… more
- Merck & Co. (Rahway, NJ)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We ... Clinical Development, has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs in the Oncology Clinical… more
- Merck & Co. (Rahway, NJ)
- …Scientist) has primary responsibility for the planning and directing clinical research activities within the Atherosclerosis and Metabolism therapeutic area, with a ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. - Specifically, the Senior Director may… more
- Merck & Co. (Rahway, NJ)
- …Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed Oncology medicines. Our company's ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary 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… more
- Merck & Co. (Rahway, NJ)
- …complementary areas of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control ... Job DescriptionOur Research Scientists are our Inventors. We identify and...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPrincipal Scientist (Director) Outcomes Research - Women's CancerUnder the guidance of a senior leader, the Principal Scientist (Director), Outcomes ... Research -Women's Cancer will be a member of the overall...reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In… more
- Merck & Co. (Rahway, NJ)
- …position resides within our company's Value and Implementation (V&I), Outcomes Research organization, which is responsible for real-world evidence generation and ... outcomes research to enable sustained patient access to our company's...reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In… more
- Novo Nordisk Inc. (Los Angeles, CA)
- 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)
- …working with clinical and cross-functional teams as clinical programs progress toward regulatory approvals. - Successful candidates will spend their first year in ... Clinical Development: Understand the role and methods of pharmaceutical research , participate in the writing of research ...of data and communication of study findings. (b) Global Regulatory Affairs and Clinical Safety: Focus on late-stage and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Global ... process improvements and workflow efficiencies. The GSM works closely with QA during regulatory agency, partner, and internal audits and Inspections, and is the IT… more
- Merck & Co. (Rahway, NJ)
- …therapeutic areas and all phases of clinical development within our company's research laboratories. TMB laboratories leverage a diverse array of technologies to ... of clinical development.Assist in the transition of biomarker assays from Basic Research to Clinical use by providing technical guidance on fit-for-purpose assay… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Biologics and Biopharmaceutics team is responsible for the research and development of sterile & parenteral drug products for biologics including ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Rahway, NJ)
- …role involves close collaboration with numerous stakeholders such as , Clinical Research Associates, Statisticians, Quality Assurance, and Regulatory Affairs to ... entry systems.Strong knowledge of GCP and GLP.Thorough understanding of clinical research and clinical trial methodologies.Strong regulatory knowledge, including… more
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