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Documentation Specialist

Allentown-Bethlehem-Easton Metro Area, PA

Posted: 01/18/2018 Job Type: Scientific Job Number: JN -012018-20760
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).

  • 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
  • BA/BS Communication, Marketing, Business, or relevant discipline
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