- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing ... in accordance with relevant regulations and policies- Good Clinical Practice ( GCP ), ICH guidelines, Sunshine Reporting, federal regulations, and within defined… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …are met according to timelines, budget, quality standards and in compliance . Proactively track, monitor and report trial risks, progress/performance, timelines, and ... relevant input and guidance to other areas within NACD including Operations Director and TA Heads Analyze And Anticipate Business Needs: Utilizes knowledge of… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of Global Clinical Drug Supply ... forefront of bringing medicines to cancer patients and other serious diseases. Director , Global Clinical Drug Supply will work in partnership with several internal… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole SummaryThe Regional Medical Scientific Director is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease expert who engages in ... questions about Company products. The work of an Regional Medical Scientific Director is aligned to: Scientific Exchange, Research, Scientific Congress Support, and… more
- Genmab (Plainsboro, NJ)
- …and utilized at a pace never seen before. Join Genmab as an Associate Director , Solution Architecture and Engineering, R&D Digital Products as part of our IT & ... IT R&D Digital Products Team. This role will be reporting to the Director of Engineering and Solution Architecture, R&D Digital Products. The Solution Architect will… 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 disease ... including field standard operating procedures (SOPs), Good Clinical Practice ( GCP ) guidelines, and administrative/operational responsibilitiesPreferredField-based medical experienceExperience in Thoracic… more
- Merck & Co. (Rockville, MD)
- …company enterprise policy agenda.Responsibilities and activities of the Senior Director , Clinical Research Policyinclude:Leads and is responsible for the Company's ... environments in the United States, including Good Clinical Practice ( GCP ) and related international standards.Proactively monitoring and interpreting the external… more
- Merck & Co. (Rahway, NJ)
- …help drive technology optimization, align teams to overall Security and Compliance Strategy and drive technology and architecture blueprints re-use.The ideal ... ISACA CISM or CISAe.g. CCSK or Cloud Architecture Certifications (AWS, Azure, GCP )Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV) service ... and aggregate reporting for DSI products, both investigational and marketed. Maintains compliance with Global PV regulations for individual case safety and periodic… more
- Merck & Co. (North Wales, PA)
- …data/medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include:Collaborating cross-functionally in the development of ... scientist.Core Skills Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing priorities with good… more
- Genmab (Plainsboro, NJ)
- …a can-do attitude to achieve results.You will be reporting to Director , Global Clinical Drug Supply in Copenhagen, Denmark.Main Responsibilities IncludeEngage with ... of clinical drug supply management.Oversee inspection readiness and ensure compliance with relevant regulations.Manage operational trial and project objectives,… more
- BeiGene (Emeryville, CA)
- …the regional Clinical Operations Americas GCP compliance team. The Director GCP Compliance collaborates effectively with stakeholders within the ... continents. For more information, please visit www.beigene.com. **General Description:** The Director , GCP Compliance , Americas provides quality guidance,… more
- Takeda Pharmaceuticals (Columbus, OH)
- …company to inspire you and empower you to shine? Join us as an Associate Director , GCP Compliance based remotely reporting to the Director , ... + Lead clinical trial functional areas and study teams on issues related to GCP compliance and liaise with study execution teams on compliance to clinical… more
- Takeda Pharmaceuticals (Boston, MA)
- …on quality compliance activities. + Provide guidance and support to GCP , PV Health Authority inspections including logistics. + Present insights to the health ... and Statistics, with at least 3 years of experience in GCP Quality/ Compliance . + Advanced knowledge of pharmaceutical development, medical affairs and … more
- Schrodinger (Cambridge, MA)
- We are looking to hire a ** Director , GxP Quality Assurance and Compliance ** to join us in our mission to discover and develop drugs that improve human health ... CAPAs, product label review, risk management, and eQMS (MasterControl) + Ensure compliance , in collaboration with relevant SMEs and senior leaders, with all… more
- Teva Pharmaceuticals (West Chester, PA)
- …in the Global Clinical Quality department, serves a critical role to ensure compliance with global Good Clinical Practice ( GCP ) guidance, laws, and regulations, ... Associate Director , Global Clinical Quality Date: Jan 7, 2025...Follow-up on inspection commitments. + Lead to resolution complex compliance issues that may affect multiple projects. + Independently… more
- Community Health Systems (Franklin, TN)
- …objectives. + Design and implement scalable, secure, and cost-effective cloud architectures on GCP and OCI. + Ensure compliance with industry best practices and ... surgery centers. **Summary:** Community Health Systems is seeking a seasoned Senior Director to lead our Cloud Data Engineering and Governance team. This role… more
- e CancerCare (Fresno, CA)
- Purpose: The Director , Clinical Trials & Research, for CCARE Physicians, PC, is responsible and accountable for the daily operations and management of staff, of the ... the finance department, the overall financial activities of the department. Assures compliance with all regulatory requirements and standards of good practice (… more
- SMBC (New York, NY)
- …a competitive portfolio of benefits to its employees. **Role Description** The Director of Cloud Security Architecture will ensure bank's cloud infrastructures are ... surfacing, driving down, and reporting on cloud security issues across our AWS, GCP , and Azure environments. This role is responsible for identifying secure cloud… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …well as maintaining compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety + Possesses proficient ... We are seeking an Associate Director to join out Oncology Clinical Development department....Proficient knowledge of clinical development process, regulatory requirements and ICH/ GCP guidelines. Does this sound like you? Apply now… more
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