- Merck & Co. (Rahway, NJ)
- …(Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the ... about twenty (20) percent of the time to manage future or ongoing clinical research projects.Qualifications Education MD or MD/Ph.D.Required Must have experience… more
- Merck & Co. (Rahway, NJ)
- …and barriers to reimbursement and market access, and provide input into clinical , regulatory , payer/access, marketing and evidence generation strategy and ... Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director, has primary responsibility for… more
- Merck & Co. (Rahway, NJ)
- …Material(s):n/aRequired Skills:Adaptability, Adaptability, Business, Business Risks, Change Management, Clinical Development, Clinical Research , ... Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full Company's Research & Development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Device Development and Commercialization process.Experience with developing and documenting regulatory strategies in coordination with clinical plans and ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: Responsibility for… more
- Merck & Co. (North Wales, PA)
- … Clinical Documentation, Clinical Investigations, Clinical Judgment, Clinical Reporting, Clinical Research , Clinical Trial Documentation, ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical...research and business development priorities and prioritization of clinical assets.-May serves as the senior liaison for relevant… 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.Summary: This position manages ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Merck & Co. (North Wales, PA)
- …collaborations, and key strategic engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) ... the strategy and leads the operational planning and execution of one or more clinical trials. In this position, you will have the opportunity to demonstrate your… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo. The candidate will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical ... from internal and external stakeholders. Collaboration with external stakeholders (eg, research pharmacists, clinical study partner management) may also be… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Quantitative Pharmacology and Pharmacometrics (QP2) Department of our Company's Research Laboratories in West Point, PA / Rahway, NJ is seeking a ... curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and...sci e ntis ts to discover and advance the clinical development of novel therapeutic agents for cardiometabolic and… 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 ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: Oversees typically… more
- Merck & Co. (Omaha, NE)
- …the right time. -We are seeking a Growth and Improvement minded Associate Specialist, Logistics who can help drive our Strategic Operating Priorities.Strategic ... SummaryThe Associate Logistics Specialist will be responsible for export of...closely with freight forwarders, QA departments, USDA and other regulatory officers. Provide data to the Finance department so… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin Our Team as an Associate Principal Scientist/ Associate Director in Biologics Drug Substance Commercialization!Are you ready to make a ... in and/or spearhead cross-divisional technical teams focused on late-stage clinical process development, characterization, and technology transfer of biopharmaceutical… more
- Merck & Co. (Rahway, NJ)
- …resolve manufacturing challenges and minimize supply disruptions.Collaborate with Research Laboratories groups during New Product Introductions/Technical Transfers ... matters.Review process change requests and deviation reports while ensuring regulatory compliance.Education and Minimum Requirements:Bachelor's degree in engineering, chemistry… more
- Merck & Co. (San Francisco, CA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. - This Associate… more
- Merck & Co. (Rahway, NJ)
- …Experience with sterile GMP facility startup.Knowledge of Investigational drug regulatory requirements.Understanding of Clinical Supply Chain Operations.Current ... biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.The Sterile Process… more
- Merck & Co. (Rahway, NJ)
- …/ our Research & Development Division ) such as Quality, Regulatory CMC, and technical functions, to ensure timebound progression of portfolio, initiatives for ... of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non- clinical , Clinical , and other functional… more
- Eisai, Inc (Exton, PA)
- …Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of ... in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the… more
- Eisai, Inc (Nutley, NJ)
- …is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, ... is your profile, we want to hear from you. Associate Director, Medical Education - Oncology, is responsible for...and regions, in addition to Publications and Scientific Communications, Clinical Development, Field HEOR, and others to execute on… more
- Merck & Co. (North Wales, PA)
- …programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data, transform the data into ... exploratory and unplanned statistical analyses.Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and… more
