The Strategic Global Labeling Director is responsible for the leadership and oversight of the Labeling function within Global Regulatory Affairs for a Therapeutic Area(s). The Director must have Regulatory Affairs experience in Global and US labeling, creating, contributing to and implementing labeling processes, and possess advanced project management and strategic labeling skills. The Director has overall accountability for overseeing his/her Team’s initial creation and relevant updates to labeling documents for their assigned developmental, mature and marketed products. This includes global labeling (CCDS/CCSI), EU (SmPC) and US labeling (prescribing information, patient information and other required labeling components) documents. This position manages a Team of Labeling Strategists and is responsible for coaching and mentoring on the strategic aspects of labeling.
- Independently provide project management throughout the entire process and leads Executive Labeling Committee (ELC) meetings for assigned product, ensuring the timely distribution of preparatory documentation, identification of issues for discussion, preparation of meeting minutes, and follow-up of action items to complete resolution. Provide strategic Labeling guidance to authors regarding appropriate content for labeling documents.
- Establish, maintain, enforce, and communicate processes and standards for global labeling. Supervise direct reports to effectively operationalize labeling activities across all products. Develop and mentor direct reports on both operational and strategic aspects of labeling.
- Follows and recommends improvements to labeling policies, processes, quality, and system tools.
- Provides and implements creative and innovative ideas to move the Global Labeling and Regulatory department to address current and future challenges.
- Responsible for all employee-related activities throughout the year, including performance management and development
- Troubleshoot and provides solutions within the team and the organization as necessary
- Provides leadership and representation for the Global Labeling team within the organization
- Leads and influences a diverse group of subject matter experts/authors of labeling documents from a variety of disciplines without a reporting relationship
- Liaise with US Labeling/Labeling Operations team to ensure compliant product labeling.
- Experience drafting and reviewing product labeling and compiling supportive documentation and demonstrate competence in marketed product labeling maintenance.
- Possess expertise and knowledge of global core data sheet guidance and US regulatory labeling requirements. Relevant experience may include a background in Drug Regulatory Affairs (i.e., FDA liaison) with experience in interpretation of FDA regulations, including exposure to labeling development and maintenance, or a background in medical writing with exposure to FDA regulations as a guide in content development for medical and/or regulatory documentation.
- Experienced or possess leadership skills to mentoring, guiding, and leading direct reports.
- Detail-oriented, well organized and good planning skills.
- Excellent communication (verbal, writing, and presentation) and interpersonal skills necessary for interacting with regulatory project managers and multi-functional labeling review teams.
Graduate degree in scientific discipline, with minimum 7 years labeling or relevant / related experience, Advanced Degree (eg, PhD, PharmD) strongly preferred
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Travel: Yes, 5 % of the Time
Job Type: Experienced