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  1. Director of Regulatory Affairs at Heartland FPG

    The Director of Regulatory Affairs provides leadership, strategy and direction for regulatory compliance and government affairs and regulatory policy for the...

  2. STATISTICIAN - CANCER CENTER WHELAN RESEARCH - MSW at Mount Sinai Health System

    Regulatory affairs of the IRB. Meets regulatory, licensure and annual health. Mount Sinai Health System Careers....

  3. Director, Health Economics and Outcomes Research at Management Recruiters of the Rockies

    Management develop and define a health economics plan, with precise value messaging and strategies to support these tactics Provide input to clinical and...

  4. Senior Clinical Research Operations Specialist at Chiltern International

    Interface with Regulatory Affairs to obtain regulatory document approval for clinical study sites; Coordinate site regulatory document collection for assigned...

  5. Director Clinical Research Immunology at Fairway Consulting Group

    Assist Regulatory Affairs in determining requirement for any corrective actions or health authority reporting....

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    1. Regulatory Affairs Manager II

      Hello, My name is Mark and I represent The Fountain Group.  We are a national staffing firm and are currently seeking a Regulatory Affairs Manager II for a prominent client of ours.  This position is located in TITUSVILLE, NJ. Details for the positions are as follows:Job Description·        This position is responsible for the management and delivery of regulatory submissions required to ...

    1. PROS- Project Leader at PAREXEL International

      PAREXEL currently has an excellent opportunity for a Project Leader/Project Manager with previous experience in Regulatory Operations and/or Regulatory Affairs....

    1. Senior Clinical Trial Manager

      The Senior Clinical Trial Manager is responsible for the oversight and management of all clinical operational activities at the trial and site level for assigned clinical projects. The leads internal cross-functional teams and manages the Sponsor relationship with vendors and CROs to ensure successful execution of clinical trials.ESSENTIAL FUNCTIONS:• Develops and coordinates clinical trial ...

    1. Director, Regulatory Affairs at Quintiles Transnational

      Responsible for the development of regulatory business, in accordance with Global Regulatory Affairs business plans....

    1. Sr. Regulatory Affairs Specialist

      Senior Regulatory Affairs SpecialistPrepare submissions for New Drug and Abbreviated Drug Product Applications according to ICH-CTD.Prepare annual reports for NDA/ANDAs by scheduling and coordinating receipt of documentation/information, preparing cover pages describing changes made to an application and tracking progress of their preparation.Review of documents and interacting with multiple ...

    1. Oncology Medical Science Liaison - Women's Cancer I/O - NY State/CT/RI at AstraZeneca

      Adhere to internal standard processes and comply with regulatory and compliance requirements. The incumbent engages in scientific information exchanges with...

    1. Document Control Assistant

      The Regulatory Operations Document Management Assistant provides general support and assistance within the department. This individual will primarily focus on scanning, archival and record management support.Candidates should:• Demonstrate a basic understanding of the rules governing development and approval of Pharmaceuticals/Medical Devices• Provide reliable interpretations of regulations ...

    1. Clinical Site Manager at Medtronic

      This position will work closely with all levels of the Clinical Affairs department as well as other departments including Clinical Operations, Marketing,...

    1. Senior Clinical Trial Manager

      The Senior Clinical Trial Manager is responsible for the oversight and management of all clinical operational activities at the trial and site level for assigned clinical projects. The leads internal cross-functional teams and manages the Sponsor relationship with vendors and CROs to ensure successful execution of clinical trials.ESSENTIAL FUNCTIONS:• Develops and coordinates clinical trial ...

    1. Director, Regulatory Affairs-CMC at Valeant

      The Regulatory Affairs – CMC Director independently manages all regulatory CMC aspects of Valeant’s Pharmaceuticals products throughout their lifecycle....

    1. Senior Clinical Trial Manager

      The Senior  Clinical Trial Manager is responsible for the oversight and management of all clinical operational activities at the trial and site level for assigned clinical projects. The leads internal cross-functional teams and manages the Sponsor relationship with vendors and CROs to ensure successful execution of clinical trials.ESSENTIAL FUNCTIONS:• Develops and coordinates clinical trial ...

    1. Director, Regulatory Affairs-CMC at Dow Pharmaceutical Sciences

      The Regulatory Affairs – CMC Director independently manages all regulatory CMC aspects of Valeant’s Pharmaceuticals products throughout their lifecycle....

    1. Clinical Submissions Architect

      Requisition ID: WD79155 Clinical Submissions ArchitectThis role enables clinical study and submission teams to deliver timely clinical trial information in electronic formats to meet the needs of global protocol, regulatory and disclosure bodies.The role monitors, manages and priorities third party preparation of Phase I-IV clinical information for clinical submissions publishing and ...

    1. HUMAN RESOURCES SPECIALIST - HRS at USAID

      Ensures that services provided meet all legal, regulatory, procedural, and policy requirements of the specialized personnel program areas....

    1. Associate Regulatory Affairs Director CMC (Chemistry Background)

       *Please note that this is a 1 year contract assignment. Candidates cannot start an assignment until background check and drug test is completed*Responsibilities:The individual will report to the Associate Director Regulatory Affairs CMC and be responsible to maintain and provide analytics for complex projects. The individual will collaborate with CMC Product Leads to summarize worldwide ...

    1. Sr Medical and Outcomes Science Liaison at Biogen

      Knowledgeable in managed care, regulatory, commercial and clinical issues affecting the pharmaceutical and managed market industry....

    1. Associate Regulatory Affairs Director CMC (Chemistry Background)

       *Please note that this is a 1 year contract assignment. Candidates cannot start an assignment until background check and drug test is completed*Responsibilities:The individual will report to the Associate Director Regulatory Affairs CMC and be responsible to maintain and provide analytics for complex projects. The individual will collaborate with CMC Product Leads to summarize worldwide ...

    1. Director, Quality Operations at N.J.S.A.

      Leads regulatory inspections and partner audits. Thorough knowledge of cGMPs and regulatory standards including their current application and interpretation by...

    1. Field MSL Director, Oncology (West) at Astellas Pharmaceuticals

      Accomplishes goals within boundaries established by regulatory and legal compliance in accordance with company policies and sound ethical practices....

      1. Manager, Health Economics & Outcomes Research, Oncology (Janssen) – Horsham, PA at Janssen Scientific Affairs, LLC

        Janssen Scientific Affairs, LLC (6120). Working knowledge of the drug development and regulatory approval process is preferred....

      2. Associate Director, Health Economics & Outcomes Research, Oncology (Janssen) – Horsham, PA at Janssen Scientific Affairs, LLC

        Janssen Scientific Affairs, LLC (6120). Represent HECOR on assigned cross-functional franchise teams, with internal partners such as HECOR colleagues, Marketing...

      3. Director, Clinical Research Physician - Oncology at Janssen Research & Development, LLC.

        Other functional groups represented on the team include project management, regulatory affairs, global clinical operations, data management, medical writing,...

      4. Director, Health Economics and Outcomes Research (HECOR), Oncology at Janssen Scientific Affairs, LLC

        Janssen Scientific Affairs, LLC (6120). Serve as a leader on assigned cross-functional teams, with internal partners such as HECOR colleagues, Marketing,...

      5. Manager, Field Clinical Analytics at St. Jude Medical

        We are seeking an experienced, high caliber Field Clinical Affairs Manager, Clinical Analytics. The Field Clinical Affairs, Manager, Clinical Analytics, will...