- Merck & Co. (Rahway, NJ)
- …Material(s):Required Skills:Adaptability, Adaptability, Business, Business Risks, Change Management, Clinical Development, Clinical Research , ... (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company Research...internal and external to GCS and serves as the lead GCS spokesperson at clinical and development… more
- Eisai, Inc (Nutley, NJ)
- …start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support, creates, and communicates clinical ... in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...your profile, we want to hear from you. The Clinical Trial Assistant will support all phases of … more
- Eisai, Inc (Nutley, NJ)
- …a team of Clinical Operations staff to oversee all aspects of clinical trial development. Lead clinical study inspections from preparation through ... in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for… more
- Eisai, Inc (NJ)
- … for active and archived studies. This includes overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ... compliance with applicable laws and regulations. The Eisai eTMF system has global users, including contract research ...relationships, both locally and globally. This role will identify, lead and participate in TMF system and… more
- Novo Nordisk Inc. (Boulder, CO)
- …Watertown, Cambridge and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for ... About the Department Our Research & Development organization brings together the best...new medicines for patients. The Position The Technical Team Lead , API Manufacturing works in Novo Nordisk's Boulder, Colorado… more
- Genmab (NJ)
- …feasibility and allocation process of a program and/or study.Must understand the Clinical Trial matrixed process from research through post-marketing Phase IV, ... Then we would love to have you join us!The Role & DepartmentThe Feasibility Lead supports the vision and strategy set forth by the Head of Strategic Feasibility.… more
- Eisai, Inc (Austin, TX)
- …and drug launch experience is strongly preferred.Knowledge of treatment guidelines, clinical research processes, FDA regulations and OIG guidelines are ... congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL/Sr....and assigned by the management.Identify and report key scientific, clinical and research insights from KOLs to… more
- Eisai, Inc (Philadelphia, PA)
- …in neurology, and knowledge of institutions focused on AD preferred 3-5 years industry/ clinical research / related experience in a scientific or clinical ... launch experience is strongly preferred Knowledge of treatment guidelines, clinical research processes, FDA regulations, pharma regulations/compliant practices,… more
- Merck & Co. (Rahway, NJ)
- …Development, Stakeholder Engagement, Stakeholder Relationship Management, Strategic Planning, System Designs, Systems Development Lifecycle (SDLC)Preferred ... Job DescriptionLocation: PA, NJ, Boston/CambridgeThe Research and Development Sciences (RaDS) value team in...the RaDS Product organization. The position will report to the- Lead of the Disease Biology and PharmTox Product Line.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …within the responsible line functions. Set the strategic direction to define best approach for clinical development systems , PV systems and MA systems ... responsible for operational and technical oversight of QA across GxP (GCP/GVL/GCLP/GLP) systems . Lead the development of the global Data Integrity strategy and… more
- Eisai, Inc (Modesto, CA)
- …and confidence in discussing drug information/ disease state management. Prior experience in clinical research , drug development and/or clinical pharmacy and ... MSL , 8+ years of overall experience in Oncology with relevant combination industry/ clinical / research / academia; at least 5 years as an MSL in Oncology… more
- Formation Bio (NC)
- …pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines ... efforts to ingest and transform unstructured and structured research , biomedical and clinical data into high-quality,...thrives on technical depth, mentorship, and platform thinking. You'll lead the design of scalable systems that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …DSI new computing environment system for programming and analysis efficiency, identify system bug/issue and lead the activity to enhance the system , ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The purpose… more
- Genmab (NJ)
- …efficiency, inspection readiness, and regulatory compliance.Act as a Data Standards or Clinical Systems Lead as needed.Regulatory and Submission ... experience in clinical data management, clinical operations, or other related clinical research experience with at least 3-5 years in data oversight and… more
- Eisai, Inc (Exton, PA)
- …and updates change control management processes and procedures for GxP systems as assigned.IT System Implementation and Maintenance: Responsible as ... GxP environments.2+ years in a leadership role in GxP Systems Quality Assurance. Must be able to lead...Systems Validation Life Cycle.Experience in managing application / system changes in accordance with GxP regulations.Proven experience in… more
- Merck & Co. (North Wales, PA)
- …a Business Technology Partner (BTP), you will report to the Development IT BTP lead within our company's Research Laboratory IT. You will be part of ... challenging diseases. Information technology is a critical differentiating capability for our research organization and a pillar of our Company's strategy, with a… more
- Formation Bio (New York, NY)
- …pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines ... scalable ML systems that drive strategic business decisions and improve clinical outcomes.If you are passionate about solving complex problems with AI and eager… more
- Eisai, Inc (Exton, PA)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... new products in development through their lifecycle (Preclinical through phase III clinical development) at the Biologics Pilot Plant as well as supporting… 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. Summary:The Associate Director, ... respond appropriately to these concerns, barriers, and the evolving marketplace. The role will lead the training efforts and support the needs of a variety of DSI… more
- Eisai, Inc (Raleigh, NC)
- …the Director will oversee Global Logistics and Import/Export compliance for commercial, clinical , and research materials. This includes the Eisai Customs and ... the Director will oversee Global Logistics and Import/Export compliance for commercial, clinical , and research materials. This includes the Eisai Customs and… more
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