- 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. (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)
- …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)
- …in end-to-end clinical trial execution in one or more key functions (eg clinical research & development, clinical science, clinical quality ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....rare diseases and immune disorders. Summary The AD, Global Clinical Operations (GCO) Clinical Trial Operational Risk… 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
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (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. (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 databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is… 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 ... agencies. Supervise designated personnel. Relationships Report to the Director/ Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory … more
- Merck & Co. (Rahway, NJ)
- …Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Primary ... or Associate Vice President, Therapeutic Area Lead.Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by… more
- Merck & Co. (Rahway, NJ)
- … regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Associate Vice-President/Vice-President ... Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …8 years' pharmaceutical or biotechnology experience in one or more key functions (eg clinical operations, clinical research , clinical science, and/or ... areas centered around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural...experience in one or more key functional areas (eg clinical research & development, clinical … more
- Merck & Co. (North Wales, PA)
- … trial publications experience (immuno-oncology experience strongly preferred)Understanding of clinical research methodology, biostatistics, and clinical ... trial program, as well as select early-stage development projects and other our Research & Development Division science. The Associate Principal Scientist is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liasions to ensure sucessful implementation ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....of CDx and data collectionSupports Regulatory affairs in providing content and providing review of… more
- Merck & Co. (North Wales, PA)
- …as statistical support for translational oncology projects and studies.-Interact with Clinical , Regulatory , Statistical Programming, Data Management, and other ... Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and standards. This position ensures quality delivery of medical coding for clinical trials, clinical development, and regulatory submissions. Develops ... authorities' requirements.Ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, ... on Component teams and/or serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other… more
- Merck & Co. (Boston, MA)
- …Medicine (TMed) Immunology strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.-The AVP provides strategic ... Job DescriptionThe Associate Vice President (AVP)/Therapeutic Area Head, Immunology Translational...network of key cross-functional partners both within TMed, Discovery Research , and Global Clinical Development.-The candidate will… more
