Manager, Global Advertising and Promotional Compliance (Wilmington)

Compensation

: $146,240.00 - $146,240.00 /year *

Employment Type

: Full-Time

Industry

: Advertising/Marketing/Public Relations



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Job Duties & Responsibilities

  • Reviews global and US promotional, disease awareness, public affairs and medical materials, attends promotional review meetings and provides regulatory guidance to the cross-functional team responsible for ensuring material compliance with global compliance standards and FDA regulations pertaining to prescription drug advertising and promotion, as applicable
  • Serves as primary contact for communications with the Office of Prescription Drug Promotion (OPDP) for assigned products, including responsibilities for the timely preparation and submission of promotional materials under cover of FDA Form 2253
  • As needed, provides training support within Alexion on regulatory requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific conferences
  • In collaboration with their manager in the Global Advertising and Promotional Compliance group, will provide advice to product development teams on advertising and promotion issues to facilitate the strategic development of new products
  • Ensures stakeholder awareness of proposed and newly approved labeling changes
  • Provide guidance to (G)MLR to ensure appropriate implementation and reflected in assigned product ISIs and promotional materials in a timely manner
  • In collaboration with their manager in the Global Advertising and Promotional Compliance group and (G)MLR Coordinator, participate in developing processes and procedures relevant to the creation, review and approval of advertising and promotional materials; develop best practices to establish standards and consistency across company products
  • Essential Qualifications

  • Bachelor Degree
  • 3 -5 years of relevant experience or relevant PharmD post-doctoral Fellowship experience
  • Solid knowledge of U.S. advertising and promotional regulations
  • Direct experience communicating and negotiating directly with OPDP
  • Experience with global standards for advertising and promotion compliance
  • Proven track record practicing sound judgment as it relates to risk assessment
  • Knowledgeable on industry compliance requirements and non-compliance examples and trends
  • Demonstrated ability to influence others and foster team collaboration
  • Strong interpersonal, communication and leadership skills.
  • Proven ability to prioritize and meet critical business timelines

  • Preferred Qualifications

  • JD, PharmD or Master's Degree preferred

  • Associated topics: advertise, advertiser, advertising, affiliate, analyst marketing, editor, market, marketing, marketing manager, sales and marketing * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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