- 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. (North Wales, PA)
- …and barriers to reimbursement and market access, and provides input into clinical , regulatory , payer/access, marketing and evidence generation strategies and ... resource utilization and costs, physician and patient satisfaction surveys, clinical and patient reported outcomes assessments, systematic reviews and meta-analyses,… 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 ... resource utilization and costs, physician and patient satisfaction surveys, clinical and patient reported outcomes assessments, systematic reviews and meta-analyses,… more
- Merck & Co. (Rahway, NJ)
- …tactical/scientific mentorship to other clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP ... Research , Clinical Study Design, Clinical Testing, Clinical Trial Compliance ,...Life Science, Medical Writing, Motivation Management, Prioritization, Problem Solving, Regulatory Compliance , Regulatory Documents {+… more
- Merck & Co. (Rahway, NJ)
- …mentorship to other clinical scientists.Core Skills Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability ... SummaryThis position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the… more
- Merck & Co. (Rahway, NJ)
- …Material(s):n/aRequired Skills:Adaptability, Adaptability, Business, Business Risks, Change Management, Clinical Development, Clinical Research , ... Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement,… more
- Merck & Co. (North Wales, PA)
- …and barriers to reimbursement and market access, and provides input into clinical , regulatory , payer/access, marketing and evidence generation strategies and ... DescriptionRole SummaryThe Principal Scientist/Director, Value & Implementation (V&I) Outcomes Research , position resides in the V&I organization, which includes… more
- Merck & Co. (North Wales, PA)
- …of an Executive Director, within the Value and Implementation, Outcomes Research the incumbent has the following responsibilities:1.) development of the integrated ... vaccines on a worldwide basis and 3.) development and implementation of Outcomes Research (OR) and Real World evidence programs to meet the value evidence needs… more
- Merck & Co. (Rahway, NJ)
- …to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's Research Laboratories ( Research ... and effective implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine… more
- Merck & Co. (Rahway, NJ)
- …managing the 'end-to-end' integrated clinical supply chain across the full c ompany's Research & Development Division portfolio of clinical trial s .- GCS is ... for clinical supplies . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address … more
- Eisai, Inc (Nutley, NJ)
- …milestones across programs in compliance with Eisai's SOP's and regulatory guidelines.Direct program level oversight of Clinical development plans (CDP) ... opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase...to this role. Responsibilities: Provide leadership and successfully manage clinical research programs, and key business objectives… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …years with focus on pharmaceutical regulatory affairs, incl. familiarity with regulatory compliance frameworks (eg, ICH, FDA, EMA) (Required)2 or more years ... Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical Development, RA CMC) to keep processes, procedural… more
- Merck & Co. (North Wales, PA)
- … Clinical Documentation, Clinical Investigations, Clinical Judgment, Clinical Reporting, Clinical Research , Clinical Trial Documentation, ... input into research and business development priorities and prioritization of clinical assets.-May serves as the senior liaison for relevant stakeholders in the… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... / our Research & Development Division ) such as Quality, Regulatory CMC, and technical functions, to ensure timebound progression of portfolio, initiatives for… more
- Eisai, Inc (Nutley, NJ)
- …ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study ... in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...and oversee the clinical operations function, ensuring compliance with GCP and regulatory standards.Develop and… more
- Eisai, Inc (Nutley, NJ)
- …an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research / operations/ data management or related area. 5+ years ... for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs),… 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, ... a difference. If this is your profile, we want to hear from you. The Clinical Trial Assistant will support all phases of clinical study activities (feasibility,… 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
- Planned Parenthood Association of Utah (Salt Lake City, UT)
- …including direct supervision of staff. Demonstrated knowledge of clinical research protocols, regulatory compliance , and ethical standards. Understanding ... Job Functions: Research Oversight & Expansion Manage and oversee ongoing research studies, ensuring full staff compliance with protocols and ethical… more
- Merck & Co. (North Wales, PA)
- …Medical, Data Coordination, Statistical Programming, Research Laboratories scientists and Regulatory staffs in designing and analyzing clinical trials and ... Trials Analysis, Data Analysis, Data Management, Data Science, Numerical Analysis, Physiology, Regulatory Compliance , Regulatory Requirements, Regulatory … more
