- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global ... make decisions where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong organization and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible for developing and executing ... About the Department The Clinical , Medical and Regulatory (CMR) department...alignment with the Evidence Generation Plan (EGP). Externally, the Associate Director RP will be the lead… more
- Insmed Incorporated (New York, NY)
- …insights to Insmed.Support research and development programs as requested by R&D, Clinical Operations, and Medical Affairs Departments. This may include trial ... addition to other unique healthcare influencers.Full support and execution of Medical Affairs plans, Clinical Development projects, programs, and initiatives.Job… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small ... and vaccinesBroad understanding of drug discovery, development and research, clinical data coding and experience working within a regulated environmentAbility… more
- Merck & Co. (North Wales, PA)
- …needs are metPartners with GST, GSC, US Regional Director of Medical Affairs (RDMA) (where applicable), US Global Clinical Trial Organization, Global ... Job DescriptionRole Summary The Hematology US Scientific Director , Medical Affairs (SDMA) is a...organizational priorities. Along with the USMA Field Leaders (Executive Director (ED)/ Associate Vice President (AV)), the SDMA… more
- Merck & Co. (North Wales, PA)
- …in a health authority regulated environment - Understanding of pharmacovigilance, medical affairs, clinical operations and product quality complaints processes ... and integrity.-Collaborate with other departments: Collaborate with departments such as clinical , regulatory, and safety to ensure that PV processes are integrated… more
- Merck & Co. (Rahway, NJ)
- …their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on programs ... and risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ResponsibilitiesLead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical TrialsAbility to extract configurable data fields from a study… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Value & Implementation (V&I), Global Medical and Scientific Affairs (GMSA) is accountable for the development and ... build and lead a team of TA dedicated global and regional directors and associate directors. The Executive Director , Value & Implementation (referred to as EDMA)… more
- Merck & Co. (Rahway, NJ)
- …approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will ... robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our success is backed by ethical integrity, forward momentum, and… more
- Merck & Co. (Rahway, NJ)
- …regulatory affairs, statistics, medical affairs and manufacturing to manage clinical development projects; and assist the Associate Vice President in ... trials and will interact externally with key opinion leaders.-Specifically, the Executive Director , PDT lead may be responsible for:-Evaluating pre- clinical and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coding quality, integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional ... Reviews and submits DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure accuracy and consistency of… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …company that will inspire you and empower you to shine? Join us as an Associate Medical Director , Clinical Science in our Gastrointestinal & ... to our inspiring, bold mission **POSITION OBJECTIVES:** The Associate Medical Director leads and...studies and compound in conjunction with Pharmacovigilance. + Oversees non- medical clinical scientists and, as applicable, … more
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