85 Wells Ave.
Post Date: 05/16/2018
Job ID: 1981
Job Category: Clinical: Regulatory
- Facilitate and Lead the development, review, approval, and maintenance of the US Package Insert (PI) and Summary of Product Characteristics (SmPC) components for assigned products either globally as a Global Labeling Lead or regional/local as a Regional Labeling Lead
- Serve as an internal expert on FDA regulations, guidance and enforcement trends governing prescription drug promotion
- Assess promotional materials to evaluate their completeness, accuracy and compliance with the Office of Prescription Drug Promotion (OPDP) requirements
- Establish and maintain interactions with FDA regarding promotional materials review and approval
- Act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labeling requirements and participate in the sharing of intelligence.
- Follows Global Labeling procedures and maintains document management systems for assigned products.
- May develop and implement policies and operational targets
- May have responsibility for management of employees that may be added to the department.
- Technical expert with sufficient expertise and experience to be considered for sensitive and/or complex assignments
- Authors and maintains core labeling documents including Core Data Sheet (CDS), core Patient Information Leaflet (cPIL), core Instructions for Use (cIFU), development Core Data Sheet (dCDS), development Core Instructions for Use (dIFU), and United States Prescribing Information (USPI).
- Manages compounds with a high degree of complexity from a labeling perspective.
- Chairs/leads Labeling Working Group and presentations to Cross-Functional Executive Labeling Board meetings.
- Advises internal and/or external experts on the creation of high quality documents supporting changes to the core labeling documents and manages the annotations within those documents.
- Provides strategic labeling advice for major regions and works with cross functional teams to ensure that the execution of global regulatory labeling plans are aligned with global regulatory strategies.
- Provides input and strategic guidance to the Target Product Label.
- Reviews and provides feedback and approves deviations from core labeling.
- Ensures deviations from labeling procedures and policies are escalated appropriately.
- Assists in preparation of responses to labeling-related Health Authority queries.
- Manages the review and approval of core Dear Health Care Provider (DHCP) letters.
- Minimum MS degree or higher in life science.
- 7+ years of regulatory labeling and Ad Promo experience within the pharmaceutical and biotech industries.
- Experience in US and global regulatory labeling and Ad Promo environments is preferred.
- Demonstrate a solid working knowledge of drug development process, as well as FDA and EU labeling
- Competent knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.
- Demonstrate strong project management, people management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral) attention to detail and ability to work under tight timelines.