- 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 ... subsidiaries in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Execution: Clinical Study Lead (CSL) for large Phase 3 registrational studies ; Develop prospective contingency plans for management of key risks in a large ... communication and decision-making process cross-functionally and cross-regionally; Facilitate team coordination. Study Outputs: For Phase 3 studies : Drafts… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … study results; Present results to regulatory agencies during pre-submission meetings; Interpret study results in context of other studies in the project and ... Program related: Integrated Study Team (IST) representative or IST leader on study team; Responsible before senior management for the creation and execution… more
- Eisai, Inc (Nutley, NJ)
- …by Translational Science to evaluate biomarkers across programs, as well as the study statistician for clinical studies . As the statistical lead for biomarker ... 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization ... and external network Manages Phase 1 - Phase 3 studies (depending on assignment) with demonstrated decision-making capabilities Provides...visits at any time during the conduct of the study to provide medical input- Provides medical guidance for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development,… more
- Merck & Co. (North Wales, PA)
- …and interprets results from clinical trials to meet objectives of the study protocol.- Independently applies and implements basic and complex techniques to these ... regulatory agencies, or individual investigators.Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors,… more
- Merck & Co. (Boston, MA)
- …to development partners. We further utilize our expertise to develop and study prototype formulations intended for clinical use, and deliver robust Good Laboratory ... in pharmaceutics assessment.DPS team in Boston, MA is seeking a highly motivated Senior Scientist for a lab-based role with creative passion for identifying and… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Medical Writer The Senior Medical Writer is responsible for developing medical writing deliverables that support the ... clinical regulatory writing portfolio. With minimal oversight, the Senior Medical Writer: Demonstrates independence in preparing clinical regulatory documents (eg,… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Quality Control Senior Specialist plays a critical role in ensuring the quality of our products by managing laboratory data and overseeing the ... to support manufacturing processes. Responsibilities of the Quality Control Senior Specialist include leading routine testing of products, driving continuous… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position, task oriented in the execution of processes, as directed by senior staff, playing a supportive role in ensuring adherence to Project objectives, ... vendors. Supports regular vendor/sponsor discussions to identify risks and ongoing study support. Identifies critical issues which may compromise patient dosing or… more
- Merck & Co. (North Wales, PA)
- Job DescriptionRole Summary:The Global Senior Director Medical Affairs (GDMA) Immunology/Pipeline & Biomarkers will be responsible for driving execution of ... meetings.Supports key countries with the development of local data generation study concepts and protocols.Reviews Investigator-Initiated Study proposals from… more
- WuXi AppTec (San Diego, CA)
- …to provide leadership in planning and conducting data analyses in clinical studies , and participate in planning and data analyses for regulatory submission.* Provide ... statistical consulting to clinical study design* Review study protocols and write...3rd party* Develop statistical analysis plans, both for individual studies and integrated analyses for regulatory submissions* Review programming… more
- Merck & Co. (Rahway, NJ)
- …testing strategy for unique combination products? Join our Company's Device Development team as Senior Engineer or Senior Scientist and be at the forefront of ... knowledge of ISO standards such as 11608, 11040 performance tests and studies including break loose and extrusion force (BLEF), breakage and burst resistance,… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Senior Scientist of Virology as part of the Research & Early Development team ... based in Piscataway. Role Overview Legend Biotechnology is seeking a senior scientist to join our exploratory technology group and contribute to new… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 ... clinical regulatory documents and submissions for own area of study / program/ marketing application, with directionExperience managing multiple projects by… more
- Merck & Co. (Rahway, NJ)
- …of the Oncology Clinical Development Finance Associate Director, the Finance Senior Specialist will:Provide financial planning, forecasting and analytical support to ... Alliances, and Collaborations Team for all project issues related to study budget, site and vendor related payments, asset valuation and impairment.Develop… more
- Merck & Co. (Rahway, NJ)
- …(DV) strategies and mechanical tests with validations, including engineering studies , design verification protocols, stability studies and validation ... protocols, ensuring appropriate selection of acceptance criteria and sampling plans. Ensures measurement systems analysis (MSA's) for all finished product performance test methods as needed in tech transfer or lifecycle.Experience with medical device… more
- Eisai, Inc (Nutley, NJ)
- …therapeutic area. Communicate and represent these plans to upper management/ senior leadership. Continuously update plans and inform stakeholders of progress.She/He ... the pharmaceutical marketplaceFDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area.Knowledge of regulatory guidance regarding… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Professional Services Veterinarian- Dermatology Specialist will function to support the commercial, medical, and business needs of the ... to collaborate and consult on research projects, including market support studies , clinical trials, grant programs, and pre-clinical development of productsScope and… more
