- Novo Nordisk Inc. (WA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... About the Department The Clinical , Medical and Regulatory (CMR) department...and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research… more
- Merck & Co. (North Wales, PA)
- …the clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study ... position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will collaborate… 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. (Basking Ridge, NJ)
- …conduct hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and ... specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies, literature, and regulatory guidelines and...in Pharmacology or Pharmaceutical Sciences or PharmD with a clinical pharmacology research fellowship and 4 years… more
- Merck & Co. (Rahway, NJ)
- …ideas and innovative solutions that enable new capabilities and technologies. As the Clinical Supply Delivery Lead for our research organization, you will be ... responsible for delivering SAP solutions to our Research Organizations' Global Clinical and Ancillary Supply-user community. You will p articipate in interviews… 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
- 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 ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. ResponsibilitiesEnsure global … more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ... Qualifications- 2 or More Years with BS required- Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryThis position serves as ... the Clinical Safety Scientist Lead for a large, late-stage program...team for assigned product(s) to author or contribute to regulatory authority requests or communicationEnsures consistent and unified safety… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our companies renowned Research and Development ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …value and market penetration, leveraging global products and insights, insights from clinical trials, and market research . Collaborate with marketing, market ... strategies Target Product Profile (TPP) Development Support: Provide support for clinical trial strategy, regulatory development, and the development of… more
- Merck & Co. (Rahway, NJ)
- … expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), ... clinical trial applications (CTDs)), and representing QP2-IO at regulatory meetings.- Minimum education required: Ph.D. with 1-3 years of pharmaceutical drug… 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
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate … more
- Merck & Co. (North Wales, PA)
- …when opportunities arise. Primary Activities :Programmatically synthesize preclinical / clinical data into analysis ready structures from varied data sourcesCreate ... tables, listings and graphics for inclusion in study reports and regulatory submissionsEnsure programmatic traceability from data source to modeling resultSupport… more
- Merck & Co. (North Wales, PA)
- …out a robust scientific leader (SL) engagement plan, coordinating with medical affairs, clinical research , and global marketing to provide a consistent One our ... Provider Promotion experience to include bringing materials through legal, regulatory , and clinical reviewNOTICE FOR INTERNAL APPLICANTSIn accordance… more
- Merck & Co. (Rahway, NJ)
- …to ensure full integration of the device development activities with the clinical , regulatory , formulation, commercial and other key company functions.Represent ... product programs under your leadership.Remain current in relevant worldwide regulatory guidance and standards.Lead/support/oversee clinical supplies production… more
- Merck & Co. (North Wales, PA)
- …includes integrating strategic and tactical input from diverse disciplines (eg, clinical , regulatory , market access, manufacturing, CMC, commercial, and other ... part of Global Project and Alliance Management (GPAM) which sits in the Research & Division organization of our company.- Position Description/Summary: The GPAM … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis is an ... strong knowledge of GMPs and GCPs and is compliant with domestic and foreign regulatory requirement but may seek support on such items from time to time.Has… more
