- Merck & Co. (Rahway, NJ)
- …and strategies to ensure optimal quality and compliance in Global Regulatory Affairs and Clinical Safety business processes.Core Responsibilities may include ... work that is executed in Global Regulatory Affairs and Clinical Safety .Ensure organizational compliance with global regulations including integration… more
- 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
- Merck & Co. (Rahway, NJ)
- …Principal Scientist) has primary responsibility for the planning and directing clinical research activities within the Atherosclerosis and Metabolism therapeutic ... Travel on company business about 20% of the time to manage future or ongoing clinical research projects. - Qualifications: Education - MD or MD/Ph.D. - Required… more
- Merck & Co. (Rahway, NJ)
- …(Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed Oncology medicines. ... twenty (20) percent of the time to manage future or ongoing clinical research projects.Education:M.D or MD/Ph.D.Required:Must have experience in industry or… more
- Merck & Co. (Rockville, MD)
- …within the company on the development and implementation of clinical research policy goals.Working closely with the Global Regulatory Policy team to ... company enterprise policy agenda.Responsibilities and activities of the Senior Director, Clinical Research Policyinclude:Leads and is responsible for the… more
- Merck & Co. (Rahway, NJ)
- …(Principal Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our ... Oncologist or Uro-Oncologist specializing in bladder cancer Prior specific experience in clinical research and prior publication is desirable but not necessary… 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)
- …Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. ... regulatory filing, and publication. - Specifically, The Executive Clinical Director may be responsible for: Evaluating pre- clinical...percent of the time to manage future or ongoing clinical research projects. Education MD, DO, MD/Ph.D,… 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 ... activities and all other associated Quality functionsUnderstands and applies regulatory / compliance requirements relative to their role.Experience working within… more
- Merck & Co. (Rahway, NJ)
- …This research opportunity contributes to the Development Sciences and Clinical Supplies (DSCS) deliverable which is the development of robust chemical and ... milestones in global healthcare.The primary objective of the Small Molecule Analytical Research and Development (SMAR&D) team is to carry out R&D activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operations methods and processes in industry setting. requiredExperience considered relevant includes clinical or basic research in a pharmaceutical company, a ... device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred. Clinical Project… more
- Merck & Co. (North Wales, PA)
- Job Description Director, Outcomes Research Vaccines Position Description Under the guidance of Executive Director, the incumbent has the primary responsibilities ... strategies, for vaccines on a worldwide basis and for planning and implementing Outcomes Research and Real World Evidence studies to meet the value evidence needs of… more
- Merck & Co. (North Wales, PA)
- …mentorship to other clinical scientist.Core Skills Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability ... SummaryThis position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the… more
- Genmab (Plainsboro, NJ)
- …and ensure effective team planning. Regulatory and Audit ComplianceEnsure compliance with country-specific clinical supply regulations.Represent GCDS during ... to fulfilling our purpose.The RoleGenmab is searching for an experienced Director, Global Clinical Drug Supply to be part of Global Clinical Drug Supply… more
- Genmab (Plainsboro, NJ)
- …strategic cross functional collaboration (ie, project/program and trialsLead/Participate in Clinical Project Supply Team discussionParticipate in regulatory ... is essential to fulfilling our purpose.Genmab is seeking a Clinical Drug Supply Manager to join our Global ...drug supply plan, milestone tracking, IMP manual, etc.Ensure GxP compliance & regulatory guideline compliance … 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
- Merck & Co. (Rahway, NJ)
- …input into research and business development priorities and prioritization of clinical assetsMay serves as the senior liaison for relevant stakeholders in the ... external community (Key Scientific Leaders, Patient Community, Payers, Regulatory Agencies)Responsible for managing, coaching, and mentoring Clinical Directors… 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 Reporting to the head of Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... multidisciplinary team environment with key stakeholders across organizations such as Regulatory CMC, formulation functions, and clinical functions to ensure… more
- Merck & Co. (South San Francisco, CA)
- …Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late-stage Clinical Research ... clinical study support staff and scientists (including discovery research , biostatistics, drug metabolism, modeling and simulation, regulatory affairs,… more
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