- 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
- 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
- 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
- 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)
- …including those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be ... responsible for guiding Product Development Team Leaders and Clinical Directors within their group to ensure that their programs are being executed effectively… more
- Merck & Co. (New York, NY)
- …dynamic individual with a strong scientific background and a growth mindset to join our team . As the Regional Cardiovascular Lead (RCL), you will have a key role ... to ensure execution against objectives.Ability to partner with other Regional Cardiovascular Lead and Customer Team Representatives to share best practices,… more
- Merck & Co. (Rahway, NJ)
- …development, and validationSelf-motivated with ability to work independentlyProven ability to lead team members of diverse skill sets and backgroundsStrong ... to ensure full integration of the device development activities with the clinical , regulatory, formulation, commercial and other key Ofunctions. Lead the Device… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities as needed for their assigned product, in collaboration with the GMA Team Lead and other GMA functions. ResponsibilitiesCollaborate with Global and ... including authors, researchers, investigators, GMA Therapy Area leads, R&D clinical leads, biostatistics and Joint Publications Team ...the quality and timeline of vendor worko Coordinate study clinical or medical lead and biostats input… 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
- 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …visits (expectations of staff contact, ISF review, IP review, SDV/SDR, etc.)Establish and lead the Sponsor Oversight Visit process. Provide oversight of the DS Trip ... for ensuring oversight of Central Monitoring activities according to the Clinical Monitoring Plan inclusive of trend identification, impact assessments and creation… 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)
- …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)
- …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)
- …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
- 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)
- 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)
- …position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling ... serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late stage...3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of… 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
