- Merck & Co. (Upper Gwynedd, PA)
- …Senior Director will report to an Associate Vice President in the Oncology Clinical Research Group. Under the guidance of a supervisor, the Senior ... has primary responsibility for the planning and directing of clinical research activities involving new or marketed...medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will… more
- Merck & Co. (North Wales, PA)
- …more of the QMS processes managed under GRACS(Global Regulatory Affairs & Clinical Safety) Quality & Compliance .Establishes and maintains an engaged Community of ... Compliance Program Development, Crisis Management, Cross-Cultural Awareness, Detail-Oriented, Global Compliance , Good Clinical Practice (GCP), IS Audit, Issue… more
- Merck & Co. (North Wales, PA)
- …Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. ... With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle...percent of the time to manage future or ongoing clinical research projects.Qualifications Education minimum required:M.D., DO,… more
- Eisai, Inc (Nutley, NJ)
- …and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) and for assuring the compliance of projects, products ... 15 or more years significant clinical pharmaceutical experience (ie, clinical development or operations, regulatory compliance ).Substantial experience in … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …outstanding leadership skills based on a sound knowledge of clinical research standards and GCP.Develop operational strategies for ... research areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff… more
- Eisai, Inc (Pittsburgh, PA)
- …an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research / operations/ data management or related area. 5+ years ... is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director...Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard… more
- Insmed Incorporated (San Diego, CA)
- …Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of ... Quality Assurance.Full understanding of and practical experience establishing and fostering compliance with ICH E6 Guideline for Good Clinical Practice.Provide… more
- Merck & Co. (Rahway, NJ)
- …execution globally across Global Regulatory Affairs CMC (Global Regulatory Affairs & Clinical Safety), Research and Development (R&D), Manufacturing, and Global ... People Management, Pharmaceutical Management, Professional Networking, Regulatory Communications, Regulatory Compliance Audits, Regulatory Requirements, Regulatory Strategy Development, Research… more
- Merck & Co. (Rahway, NJ)
- …leader to drive pipeline impact and lead a talented group of pharmacometricians.This director will be part of a leadership team responsible for applying traditional ... continue to innovate our pharmacometrics capabilities on a continuous basis. The Director will be accountable for directing a team of pharmacometricians with diverse… more
- Merck & Co. (North Wales, PA)
- …products, a product currently under review by the FDA, and an active research pipeline.We are currently recruiting for a results-driven and strategic Director , ... HIV with the potential to add other assets which are in early development. The Director , Product Marketing Owner - HCP will play a critical role in charting the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …leader for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Oncology Medical Affairs ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryUS Medical Affairs… more
- Merck & Co. (Buffalo, NY)
- …IndicatedValid Driving License:YesHazardous Material(s):n/aRequired Skills:Accountability, Clinical Development, Clinical Immunology, Clinical Research , ... Job DescriptionPosition Responsibilities The Regional Medical Scientific Director (RMSD) is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease expert… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director of Human Factors (HF) will provide visionary leadership and strategic direction for the HF function within our company. This role ... principles to enhance patient safety and product usability. The Senior Director will champion enterprise-wide HF strategy, foster cross-functional collaboration, and… more
- Merck & Co. (Rahway, NJ)
- …Product Leaders have direct impact on cost, quality, customer service, and compliance which ultimately affects access, continuity of supply, and commercial outcomes. ... GHH on the global long-range demand forecast and engage with VCM Operations Research COE on the development and maintenance of supply models and conducting scenario… more
- Merck & Co. (Cincinnati, OH)
- …and objectively interpret results -Knowledge of national and society treatment guidelines, clinical research processes, FDA regulations, and OIG, HIPAA and other ... Job DescriptionThe Virology (HIV) Regional Medical Scientific Director is a credentialed (ie, MD, PhD, DNP,...Virology is highly desirable (ie, experience in late stage clinical research as an investigator or key… more
- Merck & Co. (Rahway, NJ)
- …Plant is a Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization which enables gain of critical internal ... experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training opportunities for improved… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Regional Medical Scientific Senior Director - Team Lead (RMSD TL) is a credentialed therapeutic and disease expert (MD, PhD, PharmD, DNP, or DO) ... the team delivers high-impact scientific exchange, insights, congress engagement, and research contributions that advance USMA and V&I objectives and other corporate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: Reporting ... to the Sr. Director , Medical Affairs QA, the Director of...high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with… more
- Merck & Co. (Durham, NC)
- …Position Description: Under the direction of the Network Strategy & Execution Director , the Associate Director is responsible for assessing, leading and ... to ensure delivery of the targeted goals and timelines. The Associate Director will effectively and efficiently achieve project objectives and defined business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryMedical Affairs leader ... as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, and Global Product Team to inform clinical… more
