- Insmed Incorporated (NJ)
- …to ensure the effective and efficient execution of all operational aspects of clinical study planning, implementation, data delivery and reporting. Represents ... of clinical operations, project management, the drug development process, and clinical trial conduct, including systems and procedures, as well as the… more
- Insmed Incorporated (San Diego, CA)
- …from study design planning through final reporting of results Provide scientific input and review of clinical study data , support in assessing medical ... contract research organizations (CROs), and external vendors to prepare, review and finalize clinical study documents and...experienceExperience with EDC systems (ie, RAVE) and data analysis tools (ie, J- Review ) requiredStrong medical… more
- Insmed Incorporated (San Diego, CA)
- …hands-on experience in a validation role with responsibility for computer systems specifically LIMS, eTMF/CTMS, and other Clinical /Manufacturing systems ... guidelines and FDA/EU regulations:21 CFR Part 11, Annex 11, GAMP 5, Good Clinical Practices, GMPs, Data Integrity.Knowledge of the FDA Computer Software… more
- Merck & Co. (CT)
- …Health strategies Communicate external stakeholder opinions, insights and feedback on new data , clinical trends and the evolving medical landscape to Medical ... from SLs, including questions about our Company products and our Company data . You are responsible for facilitating and developing peer-level relationships with… more
- Merck & Co. (St. Louis, MO)
- …(HH) strategies -Communicate external stakeholder opinions, insights and feedback on new data , clinical trends and the evolving vaccine landscape to Medical ... questions from SLs, including questions about our Company's products and data . -Virology RMSDs are responsible for facilitating and developing peer-level… more
- Eisai, Inc (Oklahoma City, OK)
- …knowledge and participate in scientific exchanges and interactions with identified KOLs.Present clinical , scientific and economic data on Eisai's products and ... and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data .Demonstrate full knowledge of and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization within our company's Research Laboratories manages the end-to-end clinical supply chain for the ... company's portfolio (300+ Phase I-IV Clinical Trials, 200+ Investigator Initiated Studies and 200+ External...a proven track record in continuous improvement of processes, systems , and talent development across global, culturally diverse teams.… more
- Merck & Co. (Rahway, NJ)
- …projects, work to design, install, and qualify new equipment to support GMP clinical production. Write, review or execute test documents. Limited off shift ... improvement mindsetPRDRequired Skills: Accountability, Accountability, Adaptability, Analytical Testing, Automation, Clinical Trials, Communication, Data Analysis, Detail-Oriented, Deviation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …role will also provide oversight of technical, qualification, and validation activities including data or document review and approval as needed. This role will ... documentation (specifications, protocols, reports). Review and approve periodic review documentation for qualified equipment/ systems (audit trails, user… more
- Novo Nordisk Inc. (Irvine, CA)
- …required activity records/reports, including timely and accurate transmission of call data Understand the scientific and clinical underpinnings of brand ... ability Ability to navigate PA's in rapidly developing market Health Systems and/or Institutional Account experience is preferred Clinical approach… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Insmed Incorporated (NJ)
- …and review executed protocols Provide operational support in maintaining systems in a validated state including Change Control Assessments, Upgrade and Patch ... specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and other Clinical /Manufacturing systems .Minimum of a Bachelor's Degree in...21 CFR Part 11, Annex 11, GAMP 5, Good Clinical Practices, Data Integrity.Knowledge of the FDA… more
- Merck & Co. (Rahway, NJ)
- …implementation of risk control measures.Analyze information from post-market surveillance, clinical evaluations, and real-world evidence to inform risk management ... decisions and strategies.Utilize statistical methods to interpret risk data , providing clear and actionable recommendations rooted in empirical evidence.Work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …This role will also provide oversight of technical operations activities including data or document review , risk assessments, CAPAs, and continuous improvement ... and associated technical activities within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… more
- Novo Nordisk Inc. (Boston, MA)
- …Nordisk within a specified geographic area, engaging with selected health systems , key academic centers, specialists, primary care providers, and other stakeholders. ... broad set of stakeholders Exhibit strong understanding of health systems and ability to discuss economics of hospital and/or...Ability to view, manipulate and extract actionable insights from data to build and execute a business plan Manage… more
- Novo Nordisk Inc. (Dayton, OH)
- …of territory customer groups and affiliations such as IPAs, Medical Groups, Health Systems , and Local Clinics and uses this to identify business opportunities and ... gain access and drive business impact by collaborating around the clinical management of patients and offering NNI-approved solutions Demonstrates professionalism… more
- Insmed Incorporated (NJ)
- …FDA/EU regulations: 21 CFR Part 11, Annex 11, GAMP 5, GMPs, Good Clinical Practices, Data Integrity.Strong technical writing skills for authoring, reviewing and ... a key team member. Provide guidance and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state per… more
- Merck & Co. (North Wales, PA)
- …of training materials for the Oncology Medical Affairs team through the appropriate review systems and serves as the medical approver of these materialsDesigns, ... Advisory Board Development, Anatomic Pathology, Biomarker Development, Business Communications, Clinical Development, Communication, Consultative Approach, Data Analysis,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in-process, or final product samples submitted to the QC laboratories.Perform peer review /approval of laboratory data .Utilize electronic systems (LIMS) for ... related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP...in a manner consistent with the safety policies, quality systems and cGMP requirements.Work in a collaborative team setting… more
- Canfield Scientific, Inc (Parsippany, NJ)
- … clinical , commercial or regulatory activities Prepare, write, and review study documentation, including protocols, qualitative study reports, and study-related ... services for the pharmaceutical, biotechnology and cosmetics industries supporting global clinical trials providing primary endpoint data and supporting… more
