- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic ... creation of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections… more
- Merck & Co. (North Wales, PA)
- …with talented and dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director...analysis, regulatory reporting, and publication.- Specifically, the Senior Director may be responsible for: Providing… more
- Catalent (Harman, WV)
- Senior Director , Supply Chain Position Summary: The Senior Director , Supply Chain is responsible for leading the supply chain organization for Catalent ... additional suites coming online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological aspects of ... drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies, support Phase 2/3 studies, represent function on study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration. ... on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical ...project team members, and to a limited extent with senior management, and outside vendors; works independently for all… more
- Eisai, Inc (NJ)
- …this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to ... Salary Transparency Language:The base salary range for the Associate Director , Clinical Outsourcing is from :157,200-206,300Under current guidelines,… more
- Eisai, Inc (Nutley, NJ)
- …of the pharmaceutical marketplaceFDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area.Knowledge of regulatory ... this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics… more
- Merck & Co. (Rahway, NJ)
- …analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre- clinical and translational work ... in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director … more
- Merck & Co. (Rahway, NJ)
- …and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical , Regulatory , Statistical Programming, Data Management, and ... in strategic planning of projects.Represent statistics in meetings with investigators and regulatory agencies in discussions about clinical trial issues and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Merck & Co. (Rahway, NJ)
- …Clinical Scientist/ECS coordinates the design, planning and execution of early phase clinical trials with the Clinical Director , and internal/external ... Job DescriptionPosition Description: Senior Scientist (Early Clinical Scientist) The...processes.- Applies thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.--Represents Early Stage… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …of improving the health of our communities. About the Role:Job SummaryThe Director of Cardiovascular Clinical Business (the Department) is responsible and ... manage special projects that contribute to program development; ensures compliance with regulatory and accrediting agencies. The Director will provide oversight… 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 ... ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and...those most recent years working as an employee in clinical , medical and/or regulatory in the pharmaceutical… more
- Eisai, Inc (Nutley, NJ)
- …planning and supportive tactics for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working with ... Essential Functions Medical Affairs Strategic Plans: Under the direction of the Senior Medical Director , work with key stakeholders, management, and functional… more
- Insmed Incorporated (Bridgewater, NJ)
- …regarding the potential impact of toxicology results on Program and Clinical / Regulatory strategy.Author nonclinical sections in regulatory submission ... discipline. DABT/DACVP certification preferred.Minimum of 10 years of experience as a regulatory toxicologist (study director /monitor and/or project lead) in the… more
- Eisai, Inc (NJ)
- …of the pharmaceutical marketplaceFDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic areaKnowledge of regulatory ... If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical affairs strategy, planning and… 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 ... growth objectives via bespoke, evidence-based M&A advisory services. Reporting into the Senior Medical Director , M&A Scientific Advisory, the Medical Director… more
- Carolinas ContinueCARE Hospital at Pineville (Charlotte, NC)
- …Develop and implement quality improvement strategies.- Ensure compliance with all regulatory requirements and standards Ensure survey readiness. - Medical chart ... Manage medical records systems to ensure accuracy and compliance Skills:- Senior leadership experience in a healthcare setting- Excellent project management skills,… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic partner ... HA inspection procedures is required.Experience developing SOPs, reviewing internal pharmacovigilance, clinical , regulatory , and medical processes to ensure they… 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
