- Daiichi Sankyo, Inc. (Bernards, NJ)
- … sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member ... with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to the CSL and Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... lead the development and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of the other sections in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Merck & Co. (Rahway, NJ)
- …and ethical standards.-The Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead , Oncology Global Clinical Development, ... field of m elanoma . The Executive Director, PDT Lead will manage the entire cycle of clinical...as well as the ability to function in a team environment, are essential.- Preferred Experience and Skills: Board… more
- Merck & Co. (Rahway, NJ)
- … Clinical Supply Planning organization to customers both internal and external to Global Clinical Supply and serves as the lead Global Clinical Supply ... limited to:--Interacts closely with key partner organizations (as a lead Global Clinical Supply Planning program representative)...clinical supply planning and incorporate them into the team 's operations. - Focus on Customers & Patients. -… more
- Merck & Co. (Rahway, NJ)
- …are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in supporting the pharm and vaccine ... 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)
- …projectsAssist the Senior Director, Associate Vice-President/Vice-President and Product Development Team Lead in ensuring that appropriate corporate personnel ... Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for...as the ability to work collaboratively in a cross-functional team environmentCurrent Employees apply HERE Current Contingent Workers apply… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and ... of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and implement informatics systems and programs to support the… more
- Merck & Co. (Rahway, NJ)
- …Area and strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.- The AVP provides strategic oversight for the early ... clinical space, determining and implementing the initial ...of Translational Medicine, and sits on the T-Med leadership team . The leader must have scientific excellence in Translational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality ... disciplines and cultures. This position requires a demonstrated ability to manage/ lead people and a variety of projects concurrently. Additionally, this position… more
- Merck & Co. (Rahway, NJ)
- …and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design ... fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of...and shown to be able to motivate, influence scientific team ; lead by example through past scientific… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high performing Clinical ... This position is accountable for partnering with the Global Team leader as the Project Management lead ...and to drive the development and delivery of the clinical development plan in alignment with the product development… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple myeloma.Legend Biotech is seeking QA Document Control Leadas part of the Quality team based in Raritan, NJ. Role OverviewThe QA Document Control Lead ... management process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …external stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and ... a large program in CSPV organization.ResponsibiliteLeading efficiently and successfully a team of physicians and scientists, accountable for safety surveillance and… more
- Merck & Co. (Rahway, NJ)
- …technical solutions with the highest value, that improves the way we run our clinical trials for our patients, our partners, and our employees.Candidate will have a ... Manager, candidate will play a key role within the team working closely with PMO Leads, technical leads, software...to:Invest in data that fuel innovationModernize our current state clinical technology and business processes by implementing a new… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of new and updated Core Data Sheets, EU and US Documentation: As the project lead , Independently or through direction of a team of GLLs, manage, develop prepare ... oversight of a team of GLLs, prepare labeling documents for review. Lead review processes to ensure appropriate review and governance by Daiichi Sankyo, and… more
- Merck & Co. (Rahway, NJ)
- …Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build ... teams, building talent, and shown to be able to motivate, influence scientific team ; lead by example through past scientific / technical expertise).Highly… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform all ... Manager, Data Programmer is a member of the Biostatistics and Data Management team and performs programming tasks, including SDTM and collaborating with CROs and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Pharmaceutical Sciences and Clinical Supplies (PSCS) organization translates molecules to medicines, working from the discovery ... and the formulation development of new chemical entities through a matrix team from initial first in human formulations (suspensions, solutions, capsules, tablets)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …depth medical knowledge to provide insights and support to the cross-functional GOMA team including TA lead , medical information & education, patient advocacy, ... medical activities for assigned TA in coordination with GOMA SE lead and other relevant cross-functional stakeholders, and collate for reporting to… more
