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  1. Clinical Research Scientist - Protocol Writing

    Summary of position: Write and/or review clinical study-related documents (e.g., clinical  protocols and summary reports, clinical study reports, investigator brochures and IB updates, informed consent form, clinical study data listing/table and regulatory agency/IRB submission documents), and managing internal review of study related documentsCollaborating with internal and external team members, investigators and KOLs Participate in safety review team meetings and summarize safety findings ...

  2. Clinical Trial Manager (copy 2)

    Clinical Scientist I/II and Sr. Clinical Scientist: CNS Summary Participate in all aspects of clinical development and study management under the direction of the Director, or designee, which includes providing scientific, and/or logistical support to planned and ongoing international trials Duties and Responsibilities * Author drafts of study synopses, protocols, protocol amendments, Monitoring Plan and informed consents for Phase II-IV studies. * Contribute to the preparation of ...

  3. Clinical Scientist 13-00659

    Clinical Scientist 6 month, renewable contract w2 candidates only The Clinical Scientist is responsible for the scientific strategy of assigned clinical trials for protocol development, ensuring the review/reporting of quality trial data, and study reporting/publishing in compliance with processes, GCP/ICH and regulatory requirements. Supports program level activities as assigned. Major Accountabilities Program/project level responsibilities:   Support the development of operational plans for ...

  4. 3708350 - Clinical Scientist

    Description: The Clinical Scientist is responsible for the scientific strategy of assigned clinical trials for protocol development, ensuring the review/reporting of quality trial data, and study reporting/publishing in compliance with client’s processes, GCP/ICH and regulatory requirements. Supports program level activities as assigned. Program/project level responsibilities: • Support the development of operational plans for clinical deliverables, effectively applying principles of design ...

  5. Formulations Scientist - Transdermal - Princeton, NJ

    Shall design and develop formulations of new transdermal products. Required Experience: *** Transdermal patch physical property testing and rheology testing *** Transdermal characterization: x-ray powder diffractometry (XRPD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), and isothermal microcalorimetry (ITMC) *** Knowledgeable of scale-up, tech transfer, and process optimization. *** Familiar with transdermal manufacturing unit operations and equipment such as ...

  6. Pharma Formulations Scientist - Aerosols - Princeton, NJ

    Shall design and develop dosage forms for metered dose inhalers, dry powder inhalers, nasal sprays, and nebulizers. Required Experience: *** Design of Experiments. *** Solid state characterization: HPLC, UV-VIS, FTIR, Raman, X-ray Powder Diffraction, thermal analysis. *** Aerosol and powder characterization: cascade impaction, moisture sorption isotherm, bulk density, surface area, particle size analysis. *** Knowledgeable of scale-up, tech transfer, and process optimization. *** Familiar ...

  7. Director - Respiratory Biology - Parsippany, NJ

    Seeking a strategic expert in the respiratory disorder field with a successful track record planning and managing all preclinical activities of novel protein therapeutics and establishing pharmaceutical and academic collaborations. Shall manage a team of up to 10 scientists in target discovery, biomarker development, antibody generation, mechanism-of-action studies, and in vitro & in vivo models. Requires PhD and 10+ years of respiratory biology experience. Enjoy the career path opportunities ...

  8. Senior Sceintist Modeling and Simulation

    The Senior Scientist conducts advanced PK/PD modeling research utilizing available modeling techniques, with a focus on Oncology compounds. Primarily supports early development and regulatory filing activities by defining the dose-concentration-pharmacological effects relationships of drugs using modeling and simulation methodologies, from data acquired at various development stages. Performs population PK and PK/PD analysis for regulatory submission of various compounds. Uses state-of-the-art ...