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regulatory affairs in Pittsburgh

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  1. Medical Science Liaison (Southeast) at BTG Careers

    Act in accordance with applicable BTG values, and compliance, legal and regulatory requirements and code of conduct (Standard Operating Procedures-SOP)....

  2. International Student & Scholar Services Coordinator at Chatham University

    Assistant Vice President, International Affairs. Liaise with federal agencies and manage Chatham’s SEVIS reporting responsibilities and compliance with SEVIS...

  3. Associate Director, Safety and Pharmacovigilance at INC Research

    Extensive in-depth knowledge of global and local regulatory requirements; Maintains current professional knowledge in fields of safety management, coding,...

  4. Regional Clinical Research Associate at iCAD, Inc

    Review and collect regulatory documents and device accountability records. Accountable for data integrity, patient safety and regulatory compliance for assigned...

  5. Director at Novella Clinical

    Regulatory affairs experience a plus. Operation sections of regulatory documents including protocols, Investigator....

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    1. Sr. Manager, Regulatory Affairs

      POSITION DESCRIPTION POSITION PURPOSE A brief summary of the purpose this position must fulfill. Conduct thorough reviews and manage the preparation of new Abbreviated New Drug Applications (ANDAs), New Drug Applications (NDAs), Investigational New Drug (INDs) Applications and FDA required Annual Reports, amendments and supplemental applications in a multi-tasking environment. Ensure Company ...

    1. Regulatory Affairs Specialist at ACell

      Regulatory Affairs Specialist. The Regulatory Affairs Specialist assists the Head of Regulatory Affairs with US and international activities relating to...

    1. Senior Medical Writer, Regulatory Writing at INC Research

      Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing...

    1. Business Project Manager-State Health Insurance Exchange Lead at Cigna

      The State Implementation Lead will be the primary point of contact for the exchange and will work with a team consisting of Business/System Analysts, Subject...

    1. Regulatory Project Manager at Vermont Energy Investment Corporation

      Regulatory best practices to inform local regulatory environment. Regulatory reporting responsibilities. Manages the development of regulatory....

    1. Associate Director, Project Management - Medical Affairs Research Operations (Late Phase Trials) at PPD

      Knowledge of regulatory guidelines and Directives. The Associate Director, Project Management works effectively across multiple divisions to direct the delivery...

    1. Clinical Research Associate I or II at Delphinus Medical Technologies, Inc.

      Assists with preparation of required regulatory submissions to FDA, as requested. Assists with electronic data capture (EDC) system development, validation,...

    1. Quality Leader Customer Complaints at Becton Dickinson & Company

      Participates in external regulatory inspections. Typically requires a BS in a related life science or engineering discipline and 10 years of experience in...

    1. Medical Science Liaison (MSL) – Northeast Region at ACADIA Pharmaceuticals Inc.

      Knowledge of regulatory, compliance, commercial, and clinical issues affecting the pharmaceutical and managed care industries....

    1. Sr. Medical Science Liaison (MSL) – Northeast Region at ACADIA Pharmaceuticals Inc.

      Knowledge of regulatory, compliance, commercial, and clinical issues affecting the pharmaceutical and managed care industries....

    1. Director, New Product Planning at Takeda Pharmaceuticals

      Ten years pharmaceutical experience in Sales, Marketing, New Product Planning, Market Research, or Medical & Scientific Affairs....

      1. Medical Editor at INC Research

        Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs in the quality review of assigned...

      2. Medical Writer II at INC Research

        Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing...

      3. Legislative Affairs Specialist II at American Federation of State, County and Municipal Employees

        This position serves as a primary lobbyist in the Federal Government Affairs Department. Responds to affiliate and members’ inquiries on a wide variety of...

      4. Regulatory Affairs Specialist II - Franklin TN at Wright Medical Technology, Inc.

        Implementation and management of electronic Regulatory submission processes including conversion of dossiers into the appropriate electronic format using...

      5. Senior Medical Writer, Early Phase at INC Research

        Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing...