• Regulatory Affairs Clinical Scientist

    Posting Date 4 months ago(4 months ago)
    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 Clinical Scientist. The Regulatory Affairs Clinical Scientist is responsible for leading scientific evaluation and submission strategies related to pre-market clinical activities. This role will also research various scientific and medical topics related to the company’s technology and product lines.

    Responsibilities

    • Developing BLA regulatory strategy for clinical-related submissions including IND and module 5 of CTD regulatory filings
    • Leading the preparation and review of clinical submission documents, registration dossiers, health authority briefing packages, and responses to regulatory authorities
    • Assisting in setting up direct interactions with governmental 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
    • Assessing regulatory pathways for products and resulting phase strategy for clinical studies. Pathways could include RMAT, orphan, fast track, etc.
    • Leading defined aspects of clinical trials to ensure trials are initiated in compliance with SOPs, regulatory authority regulations, and ICH/GCP guidelines
    • Serving as a liaison to Clinical Operations study teams
    • Participating in cross-functional teams for developing and finalizing clinical study protocols, CRFs, consent forms, study reference manuals, study reports, Investigator’s Brochures, annual safety reports and other clinical documents
    • Assisting manuscript preparation and submission
    • Lending scientific advice to the planning, undertaking and oversight of clinical trials
    • Ensuring regulatory submissions are complete, accurate, and comply with applicable regulatory requirements
    • Reviewing clinical documentation such as procedural guidelines and site training materials
    • Assisting in maintenance of tissue licenses and registrations
    • Maintaining regular and punctual attendance
    • Maintaining company quality and safety standards
    • Exemplifying Cook MyoSite Core Values

    Qualifications

    • At minimum a master’s degree in any life science field and 5+ years of experience in Regulatory Affairs
    • RAC certification preferred
    • Experience in CTD-Module 5 writing preferred
    • Experience with regulatory documentation
    • Leadership abilities and team orientation
    • Stellar communication skills, both written and oral
    • Understanding of regulations and guidelines governing biological product development (particularly clinical), as well as the ability to apply these to overall strategic product development
    • 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 10-20% traveling

     

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