• Regulatory Affairs Clinical Scientist

    Posting Date 9 months ago(6/6/2018 3:13 PM)
    Requisition ID
    2018-4667
    Job Location(s)
    Pittsburgh PA United States
    Position Type
    Full Time
    Company
    Cook Myosite Inc.
    Category
    Regulatory Affairs
  • Overview

    Cook MyoSite Incorporated, a division of Cook Incorporated, is a growing, forward-thinking biotechnology organization seeking a full time Regulatory Affairs Scientist. The Regulatory Affairs Scientist will be responsible for the preparation of regulatory submissions required for clinical trials, to lead scientific evaluation, and writing of regulatory submissions of the company, including common technical documents and to research various scientific and medical topics related to the technology and company clinical studies.

    Reports to this Position: N/A

    Responsibilities

    Including but are not limited to:

     

    ·       Leading the preparation and review of clinical submission documents, registration dossiers, health authority briefing packages, and responses to regulatory authorities in relation to clinical trials

    ·       Responsible for the review of coordination and management of global clinical trial submissions

    ·       Lend scientific advice to the planning, undertaking and oversight of product trials and regulatory inspections

    ·       Participating in cross-functional teams for developing and finalizing clinical study protocols, CRFs, consent forms, study reference manuals, study reports

    ·       Participates on project teams as primary Regulatory Affairs representative providing appropriate information on regulatory issues and obtaining needed information to meet regulatory requirements

    ·       Assisting in setting up direct interactions with health authorities and personnel, including scientific reviewers, administrative staff, and management to facilitate the review and approval of regulatory applications

    ·       Maintaining knowledge of global regulatory environment, regulations and procedures related to pre-market clinical activities

    ·       Leading defined aspects of clinical trials to ensure trials are initiated in compliance with procedures, regulatory authority regulations, and ICH/GCP guidelines

    ·       Ensuring regulatory submissions are complete, accurate, and comply with applicable regulatory requirements

    ·       Maintain regular and punctual attendance

    ·       Must maintain company quality and safety standards

    ·       Exemplifies Cook MyoSite Core Values

    Qualifications

    ·       At minimum a master’s degree in any life science field

    ·       2+ years of experience working in a regulated environment

    ·       Clinical trial experience preferred

    ·       RAC certification preferred

    ·       Leadership ability

    ·       Team oriented skills

    ·       Stellar communication skills Understanding of regulations and guidelines governing biological product development (particularly clinical), as well as the bility to apply these to overall strategic product development

    ·       Must work and interact effectively and professionally with others

    ·       Must have effective oral and written communication skills

    ·       Must be detail oriented and highly organized

    ·       Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision

     

    Physical Requirements:

     

    ·       Must be able to sit at desk, in meetings and/or work on a computer

    ·       Physically capable of standing, stooping, kneeling, climbing, reaching, twisting and bending with or without reasonable accommodation

    ·       Climbing a mobile ladder and/or other types of ladders on occasion with or without reasonable accommodation

    ·       Must perform PPE gowning procedures to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (shirt and pants) and appropriate shoes required on occasion

    ·       Potential limited exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II

    ·       Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required

    ·       Ability to work under specific time constraints

    ·       Laboratory and office setting

    ·       Requires up to 10% travel

     

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