- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily...Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as ... Attends EOP2 meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase 3 registrational study(ies);… more
- Merck & Co. (North Wales, PA)
- …/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on a clinical trial team.Leading medical ... the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position,...monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin our team as a Clinical Quality Operations Lead - Inspection Strategy and be at the forefront of developing and implementing policies, ... within and outside of GCTO to ensure that Good Clinical Practice Health Authority inspections are adequately supported and...managed and that QCO are mentored and developed to lead /support regulatory GCP inspections.In this role you will: Lead… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director, Global Oncology Medical Affairs is responsible for developing the ... management from a medical perspective -Serves as Global Medical Affairs Team (GMAT) Lead , to gain strategic and planning alignment across the matrix team consisting… more
- Merck & Co. (North Wales, PA)
- … clinical regulatory writing portfolio. With minimal oversight, the Senior Medical Writer:Demonstrates independence in preparing clinical regulatory documents ... Job DescriptionThe Senior Medical Writer is responsible for developing medical...(eg, protocols, clinical study reports, investigator's brochures, clinical sections of submissions) per company and regulatory requirements.Applies… more
- Merck & Co. (Boston, MA)
- …community, research conducted in our laboratories spans exploratory biology through early clinical development and is an integral part of our company's powerful ... while advancing your career.Job Description:Our Company is currently seeking exceptional Senior Scientist peptide chemists to join our Boston site's highly… more
- Eisai, Inc (Nutley, NJ)
- …to evaluate biomarkers across programs, as well as the study statistician for clinical studies. As the statistical lead for biomarker development, this ... is your profile, we want to hear from you. Job Summary The Senior Manager, Translational Science Biostatistics will be expected to work independently with minimal… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will be ... Area strategy that will bring forth programs to successful approval and registration. Lead late-stage development for our company's assets in this TA by overseeing… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the ... outsourcing of clinical services to Clinical Research Organizations (CROs)...vendor selection and management options in alignment with global strategies. Lead the process of Request for Proposal (RFP) development… more
- Merck & Co. (Rahway, NJ)
- …our company's Research Laboratories Quality Assurance community, provide for and lead Quality Assurance oversight for computer system validation matters within the ... Development Quality organization and for the company's R&D division.For company's Clinical Supply, act as the Quality Unit representative for information technology… more
- Catalent (Manassas, VA)
- Senior Quality Auditor Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development ... and to the safety of every patient, consumer and Catalent employee. The Senior Quality Auditor will be responsible for performing supplier audits regionally and in… more
- Lundbeck (Bothell, WA)
- …Lundbeck Biopharmaceuticals is seeking a highly motivated and experienced individual to lead the Potency Assay group supporting the development of novel therapeutic ... to determine the potency of drug product for early through late-stage clinical development programs. The successful candidate will have a thorough understanding of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on ... aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead ; supports Phase 2/3...project team members, and to a limited extent with senior management, and outside vendors; works independently for all… more
- Eisai, Inc (NJ)
- …you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. As the Lead Medical Writer, ... the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle… more
- Catalent (Harman, WV)
- Senior Director, Supply Chain Position Summary: The Senior Director, Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... suites coming online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain management including,… more
- Merck & Co. (South San Francisco, CA)
- …area's biomedical community, our research ranges from exploratory biology to early clinical development. We work on diverse modalities - small molecules, peptides, ... scientist for our Modeling and Informatics group. As a Senior Scientist (R3), you will be part of a...and deep learning to problems of biological interestExperience with lead identification and lead optimization of diverse… more
- Eisai, Inc (Nutley, NJ)
- …provides strategic development, planning, implementation, and oversight of Phase IV clinical trial programs within the Medical Affairs department. She/He utilizes ... in helping to shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations. Essential Functions Work with key… more
- Merck & Co. (Rahway, NJ)
- …provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position will report to the Director, ... Engineering, Automation Lead position and will be a member of the...production, utility systems and associated infrastructure.- Responsibilities of the Senior Specialist - Manufacturing Automation include the following:The automation… more
- Merck & Co. (Rahway, NJ)
- …standards and associated processes for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards ... Job DescriptionOur Clinical Research and Pharmacovigilance team push the boundaries...across GCDS by actively communicating and proactively sharing informationSupport senior /leadership roles, in areas of observed competence, to enhance… more
