- Merck & Co. (Rahway, NJ)
- …Provides ongoing clinical database support to other departments. Assist clinical database manager /supervisor in project planning, manpower projections and ... resource allocations across therapy areas. Interface with clinical database manager /supervisor to assure consistency of technical and process strategies across… more
- Catalent (San Diego, CA)
- …AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a ... regulatory compliance, and sound fiscal responsibility. The primary responsibilities of the Senior QA Manager include activities related to GMP (Good… more
- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ location for a Senior Director, Clinical Operations.The Senior Director, Clinical ... Clinical Research Organizations (CROs) and vendors across all phases of drug development; Ensures compliance with established clinical and regulatory… more
- Merck & Co. (North Wales, PA)
- …organization at our company. Position Description/Summary The Senior Specialist, Project Manager is a core member of Early Drug Development and/or Late ... team leaders to develop strategies and execute our Company's drug and vaccine development efforts. The Senior ...(eg, MS, MBA, Ph.D., PharmD) preferred.Experience and knowledge of clinical drug development strongly preferred; including the… more
- Aequor (Thousand Oaks, CA)
- FULLY REMOTE Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on product teams, lead writing activities for ... or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in ... Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Manager /Sr. Manager , External Manufacture as part of the Technical Development ... position will be responsible for managing the technical transfer and clinical /commercial manufacture of cell therapy products in our external manufacture… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- OverviewUnder the direction of the Senior Director of Non- Clinical Drug Development and with limited direction, the Business Development Manager will be ... to expand its efforts as a Contract Research Organization.The Business Development Manager will work to uncover and cultivate business opportunities to generate… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager of Supply Chain and Logistics plays a crucial role in supporting ... both the commercial and clinical supply chains at Insmed. The primary focus is...necessarily be limited to, the following: Strategic PlanningCollaborate with senior leadership and cross-functional teams to develop and implement… more
- Aequor (West Chester, PA)
- Position Title: Sr. Manager , Global Scientific Communications Pay: /hr Bill: /hr Location: 145 Brandywine Parkway, West Chester PA Onsite or remote: West Chester ... of Heath and Human Services Exclusions Database (HHS) o US Food and Drug Administration: Debarment List (FDA) o Global Terrorist Watch Lists (OFAC, SDN, Interpol,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clear and sustainable platform of evidence generation, design and leadership of clinical development plans, and addressing all regulatory, drug and patient ... diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Clinical Operations and Marketing Effectiveness. Strong collaborations with senior leaders from Legal, Finance, Operations and Market Access as well ... requirements for transfers of value, price reporting, disclosure requirements, sharp/ drug takebacks), Representative and Organizational licensure (eg, OR rep… more
- Catalent (St. Petersburg, FL)
- …of process controls in all applicable areas of the manufacturing operation. The Senior QA Specialist will assist in organizing and prioritizing the activities and ... schedule for the QA Specialists.Provides feedback to QA Supervisor and Manager on performance of QA Specialists.Responsible for actively identifying compliance… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager , Hematology, Clinical Scientist leads in the development, evaluation, planning and execution of clinical studies and ensures integrity ... on clinical studies and programs. As a Senior Manager in Hematology Clinical ...science/healthcare preferred (PhD/MD/PharmD/MSc). Additionally, ≥ 8 years of pharmaceutical clinical drug development experience. We are seeking… more
- Stryker (Cary, IL)
- …patients annually. More information is available at www.stryker.com We are currently seeking a ** Senior Clinical Study Manager ** , to join our **Medical** ... regulations and expectations. **What you will do** As a Senior Clinical Study Manager , you...clinical study submissions and content (eg Investigational New Drug (IND), Investigational Device Exemption (IDE), Institutional Review Board… more
- Stryker (Fremont, CA)
- …Learn more about our award-winning organization by visiting stryker.com We are seeking a ** Senior Staff Clinical Data Manager ** to join our Stryker Endoscopy ... solutions, and recommend comprehensive upgrades to prevent future issues. **What you will do** As ** Senior Staff Clinical Data Manager ,** you will be the … more
- BeiGene (Emeryville, CA)
- …updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal ... study TMF QC plan + Provides input to Global Clinical Supplies regarding drug inventories in region... Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing **Quality:**… more
- Ascendis Pharma (Princeton, NJ)
- …mark. We are a dynamic workplace for employees to grow and develop their skills. The Senior Manager , Clinical Trial Supplies (CTS), Oncology will work as an ... and attention to detail is a must. + GMP manufacture experience of drug products for clinical use. + Salary range: $165-175K/year A note to recruiters: We do not… more
- Merck (Boston, MA)
- …on time and maintain patient continuity of supply. Working independently, the Clinical Supplies Project Manager (CSPM) designs strategic and operational plans ... prepares, analyses, and/or develops mitigation strategies for review with clinical partners and senior leaders. + Responsible...consolidated, visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods). +… more
- IQVIA (Bridgewater, NJ)
- Job Overview Senior Clinical Leads are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients' ... by bringing new drugs to the market faster. The Senior Clinical Lead is a member of...and therapeutic knowledge.; Req * Requires good understanding of Clinical Research industry ( drug /device/technology/etc.) and the relevant… more
