- 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 ... 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 ... Clinical Study Start-Up activities for PV Safety Operations...where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Position Reporting to the head of Clinical , medical, Regulatory (CMR) Business Operations , the Associate Director (AD) is responsible for structuring ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Oncology Regional Medical Scientific Director ( Associate RMSD) is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and ... and retention efforts to achieve study milestonesUpon request from Global Clinical Trial Operations (GCTO),Recommends study sites and identifies potential… more
- Merck & Co. (North Wales, PA)
- …health authority regulated environment - Understanding of pharmacovigilance, medical affairs, clinical operations and product quality complaints processes and ... and integrity.-Collaborate with other departments: Collaborate with departments such as clinical , regulatory, and safety to ensure that PV processes are integrated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation.Establishes… more
- Merck & Co. (Lower Gwynedd, PA)
- …Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development ... IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data.… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The Role & DepartmentThe Associate Director , Vendor Management, will play a pivotal role in managing ... for new trials to ensure efficient and effective trial operations .Point of Contact for Global Clinical Trial Managers: Act as the primary point of contact,… 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 ... a local medical and scientific resource to Insmed for product planning, clinical insights, and intelligence. Capture, synthesize and deliver HCP derived scientific… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other global sites. These business functions include but are not limited to Clinical Operations , Clinical Development, Biostatistics and Data Management, ... Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs,… 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 ... integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory, Operations , Non- clinical , Clinical , and other functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Local DSI CSPV SystemsMonitoring disruptions in customer service and internal operations , while ensuring the highest level of qualityCollaborate with internal ... a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical TrialsAbility to extract configurable data fields from a study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise:Study ... coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure...DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …+ 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
- Frontier Medicines (South San Francisco, CA)
- …is seeking a highly motivated individual to fill the position of Associate Director of Clinical Operations to help develop the early project portfolio. ... and into clinical development. The position will report to the CMO. The Associate Director , Clinical Operations will be a key contributor to Frontier… more
- Elevance Health (Cerritos, CA)
- …requests using clinical appropriateness guidelines. The ** Associate Medical Director , Clinical Operations (Surgery)** is responsible for supporting ... an impact:** + Determine medical necessity of requests using applicable clinical criteria, which may include AIM Appropriateness Guidelines, client-specific health… more
- Elevance Health (Chicago, IL)
- …plan medical policy and Medicare Coverage Determinations. The ** Associate Medical Director , Clinical Operations ** is responsible for supporting the ... imaging, cardiac testing and sleep management services. Medical Directors in Clinical Operations determine the medical necessity of outpatient radiology,… more
- Boston Health Care for the Homeless Program (Boston, MA)
- …regulatory compliance, in collaboration with the Chief Operating Officer and Associate Director of Clinical Operations . + Responsible for overseeing and ... Committee, Clinical Guidelines Committee, Nursing Billing/Coding group, and Clinical Operations . Qualifications: + License to practice professional nursing… more
- Elevance Health (Indianapolis, IN)
- ** Clinical Operations Associate Medical Director ** **Carelon Medical Benefits Management** **Radiology Benefit** **Management/Utilization** **Review** ... domains, including radiology, cardiology and oncology._ The ** Clinical Operations Associate Medical Director ** responsible for supporting the medical… more
