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Documentation Specialist

Allentown-Bethlehem-Easton Metro Area, Pennsylvania

Post Date: 05/05/2017 Job ID: JN -052017-19006 Industry: Documentation - Scientific
Description:

Duties:
  • MLR Operations (Medical Legal Review) the incumbent participates in the formal review of advertising and promotional materials; manages the day-to-day review process; and approves or rejects final production of all advertising and promotional materials;
  • Trains and collaborates with internal and external business partners to ensure compliance with appropriate MLR, corporate, and US Food and Drug Administration (FDA), rules, regulations and guidance documents; manages business partners and assists with the timely execution of project timelines;
  • Identifies project discrepancies from appropriate rules, regulations and guidance documents that may potentially have a negative impact on the organization and provides recommendations for resolution; and
  • As Manager, MLR Operations, provides final production approval of advertising and promotional materials after ensuring all required MRL Operations and Review Board comments have been resolved and incorporated (estimated US advertising and promotional budget of (USD)50+ million).
      Key Accountability% of time
      Actively participates in meetings of the MLR Review Board with particular attention to the review, assessment, and validation of advertising and promotional materials with respect to established MLR, corporate, and FDA rules, regulations, and guidance documents; ensures copyright compliance for reference materials used on advertising and promotional materials; and submits required advertising and promotional materials to Regulatory Affairs for submission to the federal government.50
      Guides project managers (Directors and Deputy Directors, Product Marketing, Sales Training, Communications, etc), agency personnel, and MLR Operations staff to ensure compliance with corporate and legal documentation standards and timely review of advertising and promotional materials.20
      Identifies project discrepancies that potentially may have negative medical, legal, regulatory, corporate, or budgetary impact and provide recommendations for resolution.20
      Develops, organizes, and implements one-on-one orientation, as well as basic and advanced MLR training seminars for new hires (project managers and agency personnel); provides updates on process enhancements to reinforce MLR policies and procedures.10
        Skills:
        BA/BS Communication, Marketing, Business, or relevant discipline
        5+ years product and customer segment knowledge as it relates to vaccines/pharmaceuticals
        5+ years of advertising and promotional material review process experience
        In depth understanding of CBER, FDA, and AMA/APA style guidelines as they relate to vaccines/pharmaceuticals
        Excellent written and oral communication skills
        Excellent time management skills
        Excellent interpersonal skills

        Education:
        BA/BS Communication, Marketing, Business, or relevant discipline

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