- Merck & Co. (Rahway, NJ)
- …(Senior Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed oncology medicines. ... study reports, or publication; andParticipation in internal and joint internal/external research project teams relevant to the development of new compounds,… more
- Merck & Co. (Rahway, NJ)
- …(Principal Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our ... study reports, or publication; andParticipation in internal and joint internal/external research project teams relevant to the development of new compounds,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … clinical studies, knowledge of drug development phases, statistical research methodology experience) Leadership skills; project management skills; effective ... in the assigned therapeutic area. Relationships Reports to the Executive Director- Clinical Research & Development. Internal relationships include working with… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Principal Scientist, Biologics Analytical Research and Development (Onsite) The Biologics Analytical Research & ... Principal Scientist position available at its Kenilworth, New Jersey research facility.-The Associate Principal Scientist is a laboratory-based scientific role… 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 ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the… more
- Merck & Co. (Rahway, NJ)
- …dosage forms, combination products and modalities. You would also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities ... Job DescriptionSenior Scientist, Small Molecule Analytical Research & Development We are seeking applications for a Senior Scientist position available at the… more
- Merck & Co. (Rahway, NJ)
- …and manage scientific activities on clinical protocols.Apply strong knowledge of clinical research regulatory requirements (eg, GCP and ICH)Manage ... the clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... corporate goals, and regional regulatory requirements/precedence.Represent Daiichi Sankyo's regulatory group in internal and external development project … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, ... and associated mitigation plans to management and other internal stakeholders Perform regulatory review of all clinical and nonclinical documents for… more
- Merck & Co. (Rahway, NJ)
- …input into research and business development priorities and prioritization of clinical assetsMay serve as the senior liaison for relevant stakeholders in the ... external community (Scientific Leaders, Patient Community, Payers, Regulatory Agencies)Responsible for managing, coaching, and mentoring Clinical Directors and… more
- Merck & Co. (Rahway, NJ)
- … trial material and in support of product and process development. Project management skills Established scientific or regulatory reputation supported by ... Job DescriptionThe Small Molecule Analytical Research and Development (SMAR&D) group has an exciting...methodologies to characterize and release raw materials, package components, clinical drug substance, and clinical drug product… more
- Eisai, Inc (Nutley, NJ)
- …and processes across clinical trials. Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with ... in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...to hear from you. Job Summary Job Summary The Clinical Trial Assistant will support all phases of … 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.SummaryThis position serves as ... the Clinical Safety Scientist Lead for a large, late-stage program...team for assigned product(s) to author or contribute to regulatory authority requests or communicationEnsures consistent and unified safety… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …not limited to) Clinical Development, Global Medical Affairs, Biostatistics, Clinical Pharmacology, Regulatory , Marketing and Market Access. Work with cross ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....Research and Development Drug Processes. Prior experience in project management or project management software such… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of ... key submission documents; Point of contact for interactions with regulatory -agency clinical reviewing divisions on clinical... reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as… more
- Merck & Co. (Rahway, NJ)
- …, Regulatory , Statistical Programming, Data Management, and our company's Research Laboratories Scientists in designing and analyzing clinical trials, and ... in coordinating the statistical activities for clinical drug/vaccine projects.Interacts with Academic Research Organization...communicate results of clinical trials to the project team, our company's Management, regulatory agencies,… more
- Merck & Co. (North Wales, PA)
- …, Regulatory , Statistical Programming, Data Management, and other company Research Laboratories Scientists in designing and analyzing clinical trials, and ... in coordinating the statistical activities for clinical drug/vaccine projects. May interact with Contract ...communicate results of clinical trials to the project team, company Management, regulatory agencies, or… more
- Merck & Co. (Rahway, NJ)
- …multidisciplinary team environment with key stakeholders across organizations such as Regulatory CMC, formulation functions, and clinical functions to ensure ... of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non- clinical , Clinical , and other functional… more
- Merck & Co. (North Wales, PA)
- …and analytical support to our Research & Development Division, Global Regulatory Affairs & Clinical Safety (GRACS), and QA organizations.Forecast spend ... Our company's mission is to be the world's premier research -intensive biopharmaceutical company.- Our Research Laboratories drive...guidance of the Associate Director who supports the Global Regulatory Affairs & Clinical Safety (GRACS) and… more
