• Merck & Co. (North Wales, PA)
    …Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to ... or clinical experience, preference if this experience is in regulatory affairs .Required Experience and Skills: Regulatory experience preferred for… more
    HireLifeScience (03/01/24)
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  • Tris Pharma (Monmouth Junction, NJ)
    …initiatives. This includes, but is not limited to: Research, Product Development, Clinical Development, Regulatory Affairs , CMC, New Products, Sales ... in our Monmouth Junction, NJ facility for a Senior Manager , Business Development.The primary role of the Senior ...provide input on deal terms and creation of relevant clinical , regulatory , and commercial scenarios Prepare clear… more
    HireLifeScience (03/25/24)
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  • Merck & Co. (Rahway, NJ)
    …Publishing (RPP) organization, which operates within the larger framework of Global Regulatory Affairs , Clinical Safety, and Pharmacovigilance (GRACS), ... Job DescriptionThe Regulatory Project Manager (RPM) is a key member of our company's Regulatory Planning and… more
    HireLifeScience (03/23/24)
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  • Catalent (San Diego, CA)
    …food or relevant industry with at least 5 years' experience in QA/ Regulatory Affairs areas with progressive responsibilities for quality metrics, quality ... , Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a… more
    HireLifeScience (02/14/24)
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  • Senior Clinical Program Manager

    Stryker (Fremont, CA)
    clinical strategies for assigned therapeutic area(s) in collaboration with Regulatory Affairs , Marketing, Research & Development, Reimbursement and Outcomes ... and extended core team members, as appropriate. + Represent Clinical Affairs on Product Development team as... regulatory body trial design experience preferred. + Regulatory Affairs Certified (RAC) or related work… more
    Stryker (03/14/24)
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  • Regional Clinical Study Manager

    BeiGene (Emeryville, CA)
    …in assigned region in close collaboration with regional study start up team and regulatory affairs + Ensures regional and country information in study systems ... progress in the region to senior management and Global Clinical Study Manager as required + Represents...region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders + Provides regional input… more
    BeiGene (03/23/24)
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  • Clinical Affairs Manager

    Teleflex (Morrisville, NC)
    Clinical Affairs Manager , Vascular (Remote, Eastern US) **Date:** Mar 12, 2024 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : ... make a difference in patients' lives. **Position Summary** The Clinical Affairs Manager provides ...access preferred + Regulatory experience preferred + Clinical and Medical Affairs experience preferred **Specialized… more
    Teleflex (02/17/24)
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  • Clinical Trial Manager

    Actalent (Alameda, CA)
    Hiring a Clinical Trial Manager for one of...with relevant company departments such as Regulatory Affairs ( RA ), Biostatistics and Clinical ... below!! M-F day shift Description: * Accountable for overall management of multiple clinical trials including: * providing strategic direction to study teams to meet… more
    Actalent (03/23/24)
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  • Sr. Clinical Research Program…

    Johns Hopkins University (Baltimore, MD)
    …+ Requires minimum of two years of management experience. + Requires experience in clinical research and regulatory affairs . + Experience in protocol and ... the division. The Sr. Clinical Research Program Manager will be responsible for ensuring regulatory ...and/or clinical trials. + Requires experience in clinical research and regulatory affairs more
    Johns Hopkins University (02/28/24)
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  • Clinical Quality Assurance Manager

    Olympus Corporation of the Americas (Center Valley, PA)
    Manager at 1-888-Olympus (###). Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs (QA/ RA ) ... purpose and our core values by staying **True to Life.** **Job Description** The Clinical Quality Assurance Manager reports directly to the Executive Director of… more
    Olympus Corporation of the Americas (03/09/24)
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  • Clinical Research Project Manager

    Dignity Health (Phoenix, AZ)
    …with organizational goals.. * Collaborate with internal cross-functional teams, including clinical operations, data management, regulatory affairs , and ... therapies for brain tumor patients. Job Description: The Ivy Clinical Research Project Manager is responsible and accountable for providing the coordination and… more
    Dignity Health (01/13/24)
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  • Senior Project Manager , Clinical

    Abbott (Maple Grove, MN)
    …and exchange of documents between stakeholders (eg, internal personnel such as Regulatory Affairs , R&D Engineering, Clinical Engineering, A&P and ... MN currently has an opportunity for a **Senior Project Manager , Clinical Evaluation** . This new team...5-7+ years of experience in clinical research, clinical affairs , regulatory affairs more
    Abbott (02/21/24)
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  • Sr. Clinical Study Manager

    Kedrion Biopharma, Inc. (Fort Lee, NJ)
    …literature and attending courses/seminars. **Relations/Network** + Interacts internally with Global Clinical Research and Operations, Regulatory Affairs , ... retention materials, in conjunction with any partner CRO project manager . + **Delivery of Clinical Trial** -...to resolution. May include preparation for and participation in regulatory inspections of selected clinical trials. +… more
    Kedrion Biopharma, Inc. (01/30/24)
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  • US Regulatory Affairs - GDP,…

    System One (Florham Park, NJ)
    Position: CONTRACTOR -- US Regulatory Affairs - GDP, RA , Associate Location: Remote (East or Central Time Zone) Contract: 12mns Pay Rate: 25/hr - 35/hr This ... Biochemistry) preferred. + Minimum of 2 years of Pharmaceutical industry experience in Clinical Development Operations or Regulatory Affairs preferred. +… more
    System One (03/06/24)
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  • Clinical Supplies Manager

    Actalent (Basking Ridge, NJ)
    …in meeting study objective, Provide supporting information to the teams, in particular RA , RACMC, Clinical ops, and GPMs. + Design packaging requirements; based ... including obtaining translations for all participating countries and the associated regulatory statements. Obtaining cross functional sign off on the labels. +… more
    Actalent (03/27/24)
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  • Pharmacovigilance Manager , Clinical

    Boehringer Ingelheim (Ridgefield, CT)
    …training and resource planning in collaboration with Clinical Operations, Medical Affairs , BDS, HEOR, Global Regulatory Affairs , Commercial teams, etc. ... Biostatistics and Data Sciences (BDS), Health Economics Outcomes Research (HEOR), Global Regulatory Affairs , Commercial/Marketing teams, etc. in areas of adverse… more
    Boehringer Ingelheim (03/01/24)
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  • Clinical Research Associate I

    Abbott (Alameda, CA)
    …study site staff, and clinical management. + Working knowledge of CFR, ICH-GCP, Clinical and Regulatory Affairs . + Flexibility in daily activities. + ... for completeness and accuracy; and escalate issues to the Clinical Operations Manager /Study Lead as needed. +...and final reviews of study data in preparation of regulatory submissions. + May interact with RA /QA… more
    Abbott (03/28/24)
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  • Associate Clinical Research II

    Abbott (Alameda, CA)
    …priorities, and to be flexible when priorities change. + Working knowledge of GCP, Clinical and Regulatory Affairs . + Flexibility in daily activities. + ... for completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed. + Participate...Clinical Protocols and Reports). + May interact with RA /QA in responding to audits and FDA inquiries. **Required… more
    Abbott (03/22/24)
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  • Clinical Research Nurse Coordinator,…

    Georgetown Univerisity (Washington, DC)
    … + Disease group members, including Principal Investigators and Physicians, Data Manager (s), and Regulatory Coordinator(s) + Clinical Research Nurses ... a timely and thorough manner + Collaborate with data manager (s) to assure the documentation for the clinical...with regulatory team and protocol office regarding regulatory affairs + Act as a liaison… more
    Georgetown Univerisity (01/17/24)
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  • Associate Clinical Research III

    Abbott (Alameda, CA)
    … data listings for completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed. + Proactively and effectively communicate the ... Master File (TMF), Clinical Protocols and Reports). + May interact with RA /QA in responding to audits and FDA inquiries. **Required Qualifications** + BS degree… more
    Abbott (03/15/24)
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