Description
Responsibilities- Accountable for the development, management, implementation and maintenance of Core Data Sheets of all Consumer Healthcare products.
- Responsible for facilitating Core Labeling Committee(s) and leading labeling discussions for the purpose of initiating core data sheet revisions and for creation of new core data sheets for Consumer Healthcare products. This encompasses development, analysis, interpretation and coordination of medical information needed for team to develop or revise Core Data Sheets.
- Manage Requests for Medical Consultation (RMC) of local labeling, Requests for Labeling Discussion (RLD) which may impact core data sheet content, and Affiliate Exception Requests (AER).
- Develop, manage and maintain Core Data Sheets for Consumer Healthcare products.
- Manage and facilitate Core Labeling Committee meetings, which encompass development of agendas, background information necessary for appropriate review of the topics, moderation of discussions and preparing minutes in a timely manner.
- Serve as the central point of contact for Consumer Healthcare affiliates on Requests for Medical Consultation (RMC) of Labeling and clarifying with countries when a Request for Labeling Decision (RLD) will be needed.
- Ensure that Affiliate Exception Requests to deviate from CDS are reviewed by the appropriate forum and receive appropriate review and approval.
RPh or Pharm D required with at least 5 years of experience in the pharmaceutical industry - OTC experience is a plus; Proficiency on International/Global Compliance or Labeling is a plus; A solid knowledge of Pharmacology is necessary; Experience in safety is a plus; Specific experience with analgesics, respiratory, dermatological, or nutritional products is a plus.
Synectics is an Equal Opportunity Employer.