- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development ... Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the… more
- Merck & Co. (Rahway, NJ)
- …Guidelines, Life Science, Medical Writing, Motivation Management, Prioritization, Problem Solving, Regulatory Compliance , Regulatory Documents {+ 4 ... clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g... Clinical Research, Clinical Study Design, Clinical Testing, Clinical Trial Compliance ,… more
- Merck & Co. (Rahway, NJ)
- …mentorship to other clinical scientists.Core Skills Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage ... the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position,...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, ... a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (Rahway, NJ)
- …and effective implementation and oversight model to maintain best in industry regulatory compliance .The Vice President Regulatory Affairs, General Medicine ... contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function...in the US and globally to execute efficiently on regulatory obligations, compliance requirements and company strategy.Providing… more
- Merck & Co. (Rahway, NJ)
- …for clinical supplies . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… 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
- 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) ... want to hear from you. The Executive Director, Global Clinical Development resides within the Oncology at Eisai. This...opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase… more
- Merck & Co. (North Wales, PA)
- …in the external community (Key Scientific Leaders, Patient Community, Payers, Regulatory Agencies)Responsible for managing, coaching, and mentoring Clinical ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Pediatrics will focus on driving strategy, development, and life-cycle… 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 ... function in the execution of all aspects of end-to-end clinical trials with the utmost compliance and...and oversee the clinical operations function, ensuring compliance with GCP and regulatory standards.Develop and… more
- Eisai, Inc (Nutley, NJ)
- …for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), ... regulatory standards and guidelines for the conduct of clinical trials. Demonstrated ability to operate and influence decision-making processes Effective… more
- Eisai, Inc (Nutley, NJ)
- …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, ... start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead(s). Plans, support, creates, and communicates clinical … 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)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non- clinical , Clinical , and other functional… more
- Shady Grove Fertility (Rockville, MD)
- …related field (or equivalent experience). Minimum 1-2 years of experience in regulatory , compliance , clinical operations, or laboratory coordination. Prior ... to you. We are seeking a detail-driven and proactive Regulatory Coordinator to join our Clinical Operations...our "job." In general, the position is responsible for: Regulatory Oversight & Compliance Ensure FDA-required donor… more
- Merck & Co. (North Wales, PA)
- …Trials Analysis, Data Analysis, Data Management, Data Science, Numerical Analysis, Physiology, Regulatory Compliance , Regulatory Requirements, Regulatory ... design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase… more
- Merck & Co. (North Wales, PA)
- …Risks, Life Science, Medical Writing, Motivation Management, Prioritization, Project Management, Regulatory Compliance , Regulatory Documents, Science {+ 4 ... study specific partners and/or vendors.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and... Clinical Research, Clinical Study Design, Clinical Testing, Clinical Trial Compliance ,… more
- Merck & Co. (Rahway, NJ)
- …drug/vaccine projects under supervision in Late Development Statistics. --Interacts with Clinical , Regulatory , Statistical Programming, Data Management and other ... these analyses.Prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or… more
- Merck & Co. (North Wales, PA)
- …and key strategic engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability ... the operational planning and execution of one or more clinical trials. In this position, you will have the...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Merck & Co. (South San Francisco, CA)
- …ms of experienced sci e ntis ts to discover and advance the clinical development of novel therapeutic agents for cardiometabolic and ophthalmologic diseases. You ... model-based strategies ( translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc) for quantitative analyses, within and across… more
