- Merck & Co. (Rahway, NJ)
- … Clinical Development, has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs in the Oncology ... Clinical Research group and in the field...regulatory requirements, the competitive landscape, and commercial considerations.Planning clinical trials (design, operational plans, settings) based on these… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Writing is a key role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. ... requires collaboration across various functions to meet aggressive timelines. Clinical regulatory documents include, but are not...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… 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 ... you ready to make a difference? The Position The Associate Director, Research Partnerships (RP) is responsible...number of stakeholders across CDSE and more broadly within Clinical , Medical and Regulatory , Market Access and… more
- Merck & Co. (Lower Gwynedd, PA)
- …(eg, neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility ... Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the...group located at our Company's new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this new… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality standards and timelines and that quality of data is suitable for regulatory submission.The Associate Director will have routine interaction with key ... trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director, Clinical Operations may act as the Study Team… 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
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for ... information) for the Genmab portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr Director, Labeling, Policy and… more
- Genmab (NJ)
- …to the effective planning, and timely delivery of complete, high quality and reliable clinical trial data. The Associate Director DM will provide oversight to ... collection, data review and cleaning activities and analysis and reporting in clinical trialsExperience and understanding of GCPs, SOPs, regulatory requirements… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Respiratory will focus on driving strategy, development, and ... input into research and business development priorities and prioritization of clinical assetsMay serves as the senior liaison for relevant stakeholders in the… more
- 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 ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Oversees typically… more
- Genmab (Plainsboro, NJ)
- … projectsExperience managing/guiding internal (cross-functional) and external (CRO, regulatory authorities) teamsSome experience with operational management and ... our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a… more
- Merck & Co. (Rahway, NJ)
- … regulatory affairs, statistics, and manufacturing to manage clinical development projects Assist the Associate Vice-President/Vice-President and ... Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ... or More Years with Bachelor of Science required- Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Principal Statistical Programmer - Oncology (Hybrid) In BARDS (Biostatistics and Research Decision Sciences), a ... distinguished department within our Company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference? The Position Reporting to the head of Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for ... About the Department The Clinical , Medical and Regulatory (CMR) department...internal stakeholders. In the execution of specific projects, the Associate Director, will be accountable for managing relationships with… more
- Merck & Co. (North Wales, PA)
- …accuracy and integrity.-Collaborate with other departments: Collaborate with departments such as clinical , regulatory , and safety to ensure that PV processes are ... communication, and leadership skills, as well as a thorough understanding of regulatory requirements and quality standards. -Knowledge of Research and… more
- Genmab (NJ)
- …biological, pharmaceutical science or related discipline Minimum of 8 years of experience in clinical research with at least 4 or more years of drug development ... development plan (CDP) Author components with Medical Director and reviewer of clinical and regulatory documents and registration dossiers (ie, protocol, ICF,… more
- Merck & Co. (North Wales, PA)
- …datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing ... of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is… more
- Genmab (NJ)
- …as trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and ... be our best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director acts as a statistical expert supporting the clinical development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory /Risk Management, Quality Assurance, Medical Affairs, Translational Research , ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....but are not limited to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory … more
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