- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Technical Data Reviewer reports to the Data Review Supervisor or quality management (ie, Manager or Director). The reviewer will be ... with Raw Material, Finished Drug Products, Stability and Microbiology testing. Data Review may include release, raw material, and stability data and laboratory… more
- Merck & Co. (St. Louis, MO)
- Job DescriptionRole SummaryThe Regional Medical Scientific Director (RMSD) is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease expert who engages in ... bidirectional exchange of scientific or medical information with Scientific Leaders (SLs). The role provides balanced, factual, scientific information about… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the ... scientific value of our products is understood. We connect,...thorough understanding of the science behind the medicine and review further unmet medical needs to support collaboration to… more
- Aequor (Seattle, WA)
- …to internal and external QC labs.Contributes to the formulation of sound scientific strategies to ensure regulatory acceptance of biological assays in clinical ... and analysis of experimental results.Oversees experimental design, execution, data review and analysis, document writing, and contributions to regulatory… more
- Merck & Co. (North Wales, PA)
- …& therapeutic area expertise to participate in the strategic planning and global scientific content development, review of standard response document on product ... to help answer unsolicited medical information requests. The Medical Consult and Review Physician provides medical and scientific training to internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as expert reviewer on study designs, protocols, results and scientific communications (eg, qualitative or quantitative method review ) Facilitates integration ... or other patient-centric concept of clinical benefit Ensures the scientific quality and integrity of patient focused research through...obtain COAs on labels, industry trends) Ensures scientific integrity of PED research through serving… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and ... standards for continuous improvement and operations excellence. This may include the review of business partner SOPs and participation in QA initiatives.Partner and… more
- Genmab (NJ)
- …clinical development plan (CDP) Author components with Medical Director and reviewer of clinical and regulatory documents and registration dossiers (ie, protocol, ... development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables (eg database lock… more
- Merck & Co. (Rahway, NJ)
- …will have an essential strategic and tactical role in overseeing the scientific direction of clinical programs involving translational research and early clinical ... governance for the Cardiovascular & Respiratory portfolio (discovery therapeutic area review , early and late-stage clinical governance), and fully supportive of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …PublicationsMay contribute to addressing questions about medical decisions, clinical data review , protocol deviations, etc., and/or scientific aspects of the ... science and technology. With more than 125 years of scientific expertise and a presence in more than 20...Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan (IDRP)Accountable… more
- BioAgilytix (Durham, NC)
- …join our Cell & Gene Therapy team. The ideal candidates will have scientific lab experience with hands-on experience in a lab environment (academic or professional) ... at BioAgilytix.Essential ResponsibilitiesCompile/process data (make power export)Prepare summary tablesPeer review raw dataOrder reagentsParticipate in PCR assay development and… more
- Insmed Incorporated (San Diego, CA)
- …for meetings as it related to the protocol(s) and program Provide protocol level scientific review of information to support the development and updates for ... other clinical scientist(s), medical monitors, and drug safety to provide support and scientific review of safety dataProvide scientific review of study… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director, Value & Implementation (V&I), Global Medical and Scientific Affairs (GMSA) is accountable for the development and execution of ... scientific & medical affairs plans for Ophthalmology). They build...with V&I Outcomes ResearchSupports the Investigator-Initiated Study programLeads talent review process and demonstrates follow-through on Development Plans for… more
- Merck & Co. (Rahway, NJ)
- …technical functions, to ensure timebound progression of portfolio, initiatives for scientific & operational excellence, and other strategic goals that advance ... and regulatory community is expected, as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Document Control Specialists to meet goals and deadlines.Serve as a Document Control reviewer for new and revised procedures and documents to ensure compliance with ... workflow handling and electronic system usage, as needed.Manage the periodic review process for procedures, as needed.Issue batch related documentation and labels… more
- Merck & Co. (Rahway, NJ)
- …a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover and develop the next medical ... the underlying biopharmaceutics science within the organization and the external scientific community. The successful candidate:Should have a vision to develop a… more
- BioAgilytix (Durham, NC)
- …milestone-driven environment, actively contributing to data generation while providing scientific input.As a Scientist I, your day-to-day activities will include:Run ... GxP principlesPrepare worksheets independentlyAnalyze & interpret dataPrepare summary tablesPeer review raw dataPrepare buffersTroubleshoot assaysDesign assay runs independentlyResponsible for… more
- Taiho Oncology (Philadelphia, PA)
- …Affairs Department with a primary responsibility to engage in the exchange of scientific data, education of health care practitioners on Taiho products and relevant ... disease states, and facilitation of clinical research. The MSL integrates clinical/ scientific expertise and knowledge to ensure successful implementation of the… more
- Merck & Co. (North Wales, PA)
- …and health care environment knowledge through self-study of company-provided scientific , product and marketplace information, attendance at product workshops and ... conferences, as well as consistent and ongoing review of our Company's promotional materials.-Utilizing analytical skills and tools to engage customers in quarterly… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …maintains Datavision publication records and reporting As needed, prepare and review manuscripts, meeting abstracts, scientific poster presentations, including ... This position reports to a Director Level Team Member within Scientific Communications (SC), Medical Affairs. The Manager-Publications is expected to develop… more
