Successfully lead the development and maintenance of label content for marketed products within assigned therapeutic areas. Adhere to all procedures related to label content development, maintenance, and implementation and maintain these procedures to assure process integrity and effectiveness. Successfully execute labeling implementation strategies and assure compliance by all affected functions. Work with functions affected by labeling implementation to assure that content review/approval procedures are in place for all labeling documents. Candidate must be proficient in effectively leading teams to successful outcomes and must be proficient in all FDA labeling regulations and guidances. Candidate must be able to provide sound interpretation and successfully apply the FDA regulations and guidances to all work output.
This position can be based in one of our three locations: Frazer, PA, Parsippany, NJ or Overland Park, KS