- 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
- 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)
- …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
- 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
- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in ... to drive data excellence and enhance the efficiency of our clinical research operations .Key Responsibilities:- Lead Data Management Initiatives:-Direct the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company ... Research Laboratories portfolio of clinical trials.- Global Clinical Supply is accountable... supply planning and incorporate them into the team's operations . - Focus on Customers & Patients. - Make… more
- Merck & Co. (Rahway, NJ)
- …integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory, Operations , Non- clinical , Clinical , and other functional ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… 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
- 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
- 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. (Basking Ridge, 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… more
- Merck (Rahway, NJ)
- **Job Description** **Job Overview:** We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in ... Affairs to drive data excellence and enhance the efficiency of our clinical research operations . **Key Responsibilities:** - **Lead Data Management… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …with the marketed product. + Conduct training and awareness programs in order to educate Clinical Operations staff on the importance of diversity in clinical ... the sharing of lessons learned and current best practices across the Clinical Operations organization. + Provides oversight, and coaching to study teams to… more
- Daiichi Sankyo Inc. (Basking Ridge, 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
- Merck (Rahway, NJ)
- **Job Description** The Global Clinical Supply organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full company ... Research Laboratories portfolio of clinical trials. Global Clinical Supply is accountable... supply planning and incorporate them into the team's operations . **Focus on Customers & Patients.** **Make rapid, disciplined… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …innovation-driven company to inspire you and empower you to shine? Join us as a Associate Director , Business Operations DMC Lead based remotely, reporting to ... the Executive Director , GDO Business Operations . At Takeda, we...DMC/IRC R&D wide communication strategy. + Partner with Global Clinical Development Operations Process Excellence and Delivery… more
- Bristol Myers Squibb (Princeton, NJ)
- … of Finance Strategic Operations & Data Strategy, the Finance Associate Director of Portfolio Management will be responsible for strategically managing, ... Join us and make a difference. Position Summary The Associate Director of Portfolio Management plays a...Portfolio Management plays a pivotal role within Finance Strategic Operations overseeing and optimizing the Finance of the Future… more
