Clinical Regulatory Documents Associate Jobs | Glassdoor

Clinical Regulatory Documents Associate Jobs

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  • 3.1
    United Health Services Hospitals – Binghamton, NY
    Est. Salary $45k-$63k
    5 days ago 5d
    in Binghamton, NY Clinical Regulatory Analyst Under general direction or assignment serves as a clinical resource in the training… in clinical area or Associates Degree with 3 yrs relevant experience in a clinical area and 3 years experience in clinical setting…
  • RaNA Therapeutics – Cambridge, MA
    EASY APPLY
    Est. Salary $62k-$140k
    13 days ago 13d
    and interpret scientific and clinical data, and to problem-solve complex regulatory and clinical issues. Ability to present… assess regulatory risks associated with different strategies; and help internal teams problem-solve complex regulatory and clinical…
  • 3.9
    Guardant Health – Redwood City, CA
    Est. Salary $166k-$227k
    1 days ago 12hr
    protocol, regulatory requirements, and company SOPs. Identifies, documents, and discusses protocol violations, regulatory non-compliance… registrations for CDx assays. Effectively prepare regulatory submission documents in adherence with applicable Regulations and Directives…
  • 3.7
    Children's Medical Center – Dallas, TX
    Est. Salary $69k-$89k
    1 days ago 16hr
    practitioners, educators and other resources Quality/PI/Regulatory Comply with state, federal and other regulations Participate… thorough physical assessment if patient presents with unstable clinical findings on patients requiring nursing assessment Patient…
  • 3.5
    Advocate Health Care – Park Ridge, IL
    Est. Salary $61k-$77k
    7 days ago 7d
    practice, and current regulatory requirements. Educates all internal customers on clinical documentation opportunities, coding… practice and associates to work. Clinical Documentation Specialist RN This role will facilitate the modifications of clinical documentation…
  • 3.9
    St. Joseph's Regional Medical Center – Paterson, NJ
    1 days ago 16hr
    teaching and promotion. Practices in accordance with established regulatory standards. Demonstrates competent behavior in the professional… organizations outstanding physicians, superb nurses, and dedicated clinical and professional staff have made us one of the most highly…
  • 2.7
    SeraCare Life Sciences, Inc. – Gaithersburg, MD
    1 days ago 1d
    Execute, maintain, and improve the Document Control program per internal and regulatory policies and procedures; copy, distribute… version of new or revised documents for approval Maintain, document and provide feedback on the Document Control system with high…
  • 2.3
    Keryx Biopharmaceuticals – Boston, MA
    Est. Salary $50k-$117k
    26 days ago 26d
    sections of all regulatory submissions (INDs, NDAs, CTXs, meeting requests, and briefing documents) to support clinical trials and… Reporting to the Vice President of Regulatory Affairs, the Associate Director/Director of CMC Regulatory Affairs will be responsible…
  • 2.9
    Natera – San Carlos, CA
    Est. Salary $65k-$96k
    9 days ago 9d
    product release documents. Reviews clinical protocols to assure collection of appropriate data for regulatory submissions.… .S. regulatory associates to register or license products outside the U.S. Interacts and negotiates with U.S. regulatory agencies…
  • 2.8
    Novavax – Gaithersburg, MD
    13 days ago 13d
    Participates in resolving deviations associated with the Document Management System Handles non-routine situations for review… volumes of documents which includes filing, scanning and archival of documents. Assist in the coordination of document management…
  • 3.3
    PAREXEL – United States
    5 days ago 5d
    opportunity to join PAREXEL's Regulatory Outsourcing Services (PROS) Team as a Senior Regulatory Associate. We are seeking a highly… advancement. The Senior Regulatory Associate can be office based in San Diego, CA with our team of Regulatory experts or work decentralized…
  • 2.3
    Keryx Biopharmaceuticals – Boston, MA
    Est. Salary $118k-$189k
    7 days ago 7d
    reports, briefing documents, INDs, NDAs, and other regulatory documents Assist with budgeting activities (for clinical trials and… scientific input in authoring key clinical study documents including synopses, protocols, clinical study reports, Investigational…
  • 3.5
    Duke Clinical Research Institute – Durham, NC
    1 days ago 13hr
    Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum… data structure design, technical specifications and associated documentation. Often this includes leading a cross-discipline/cross…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $129k-$177k
    26 days ago 26d
    submission of regulatory documentation, including 510(k)s and Investigational Device Exemptions (IDE) in compliance with regulatory agency… Ability to review regulatory and scientific submission documents for accuracy and adherence to regulatory requirements, noting…
  • 2.5
    BioClinica – Orlando, FL
    1 days ago 16hr
    The Regulatory Associate is responsible for the processing of regulatory packets/documents, maintenance of regulatory files,… Responsibilities: Prepare regulatory documents for new study submissions to IRB and sponsor Maintain regulatory files at audit-ready…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $87k-$144k
    27 days ago 27d
    and manage regulatory submission teams; create and track regulatory CMC submission timelines. • Support CMC regulatory activities… management for CMOs and Regulatory CMC consultants • Develop and maintain project schedule and track regulatory commitments for responses…
  • 3.5
    Duke Clinical Research Institute – Durham, NC
    Est. Salary $86k-$126k
    1 days ago 1d
    to assess protocol, regulatory, and SOP compliance with some guidance from an experienced CRA or a clinical trial lead. May travel… and SOPs. Assess protocol and regulatory compliance, including but not limited to source document verification, informed consent…
  • 3.6
    ACADIA Pharmaceuticals – United States
    6 days ago 6d
    CTM documentation necessary to support company policies, procedures and all regulatory guidelines. Works with Clinical, Regulatory… and experience in clinical trial methodology and Good Clinical Practice. Good organizational and documentation skills. Demonstrated…
  • 3.3
    U.S. Department of Veterans Affairs – Temple, TX
    Est. Salary $58k-$79k
    6 days ago 6d
    Education/Documentation Consultant The RN Education/ Documentation Consultant is responsible for providing clinical expertise… to date knowledge of advanced clinical concepts, healthcare regulations, clinical documentation requirements, coding/ compliance…
  • 3.5
    BJC HealthCare – Saint Louis, MO
    1 days ago 15hr
    practices for CDI program and clinical documentation staff. Ensures all compliance and regulatory standards are met. Minimum Requirements… guidelines related to Clinical Documentation Improvement. Serves as a resource for the Clinical Documentation Specialist (CDS) team…
  • 2.4
    Intarcia Therapeutics, Inc. – Hayward, CA
    Est. Salary $102k-$239k
    13 days ago 13d
    meetings with regulatory agencies, and ensuring appropriate follow-up • Review Clinical study protocols, Clinical study reports… developing global regulatory strategies for program and leading the preparation and submission of regulatory documentation including IND…
  • Randstad Life Sciences – Cambridge, MA
    11 days ago 11d
    Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.… activities associated Contract Research Organizations (CROs) This person will help ensure that all documents for regulatory applications…
  • 2.9
    Wonderful Pistachios and Almonds – Los Angeles, CA
    Est. Salary $68k-$117k
    26 days ago 26d
    Global Regulatory Affairs will be part of the Regulatory Team, responsible for overseeing regulatory compliance associated with… globally, and will report to the Associate General Counsel -- Regulatory Affairs. The Regulatory Team is part of the legal group…
  • 3.6
    AbbVie – South San Francisco, CA
    Est. Salary $115k-$191k
    12 days ago 12d
    scientific discipline or 10 years of regulatory documentation and operations experience Regulatory Affairs Certification is preferred… and experience with regulatory submissions, including INDs, international clinical trial applications, and marketing applications…
  • 4.3
    Beacon Hill Staffing Group – Northbrook, IL
    1 days ago 1d
    Pharma/Clinical Research Location: Northbrook, Illinois, USA Description: Seeking a Regulatory Documentation… Posted Date: 4/17/2017 Job Title: Regulatory Documentation Specialist Job Type: Temporary/Contract…
  • 2.6
    HealthEast Care System – Saint Paul, MN
    Est. Salary $62k-$82k
    1 days ago 14hr
    Collects and analyses pertinent data and/or clinical findings. Incorporates clinical findings and scientific evidence in the development… efficiency and effectiveness outcomes Complies with regulatory requirements, patient safety requirements, infection control practices…
  • 2.8
    CorTech International, LLC – Lake Forest, IL
    Est. Salary $45k-$70k
    Today 10hr
    Oversee quality control of regulatory documents and submissions ⢠Organize meetings with regulatory agency staff ⢠Update and… contributor; the function of a Regulatory Affairs Associate is to provide support for regulatory processes and procedures. The…
  • 3.3
    SCL Health System – Wheat Ridge, CO
    Est. Salary $56k-$71k
    1 days ago 16hr
    in clinical team conferences regarding patient progress, problems and needs. Act in compliance with hospital, regulatory and… with evaluation, treatment and documentation guidelines described. Complete required documentation in an accurate and timely manner…
  • 3.6
    San Manuel Indian Bingo & Casino – Highland, CA
    Est. Salary $73k-$142k
    1 days ago 16hr
    programs and services in a manner consistent with all legal and regulatory requirements and in compliance with relevant laws and regulations… compliance with applicable law. While not directly providing clinical counseling, the Social Services Director coordinates with private…
  • 2.5
    Medpace – Cincinnati, OH
    5 days ago 5d
    currently seeking a full-time, office-based Document Security Administrator to join our Regulatory Submissions team. This position will… Responsibilities Document Security Administrator Medpace is a global, full-service Clinical Research Organization (CRO…
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