Responsible for the facilitation and management of the labeling, promotion and artwork processes; including leading the development, review, approval and maintenance of labeling, corresponding artwork components and promotional and Medical materials. Responsible for label text development, compilation of supporting documentation and preparation of forms, claims approval, artwork review and approval, and file maintenance. Schedule and facilitate labeling and artwork project team meetings. Prepare, review and submit to FDA the Structured Product Labeling (SPL), obtain and maintain National Drug Code (NDC) numbers, prepare and submit mandatory dietary supplement notifications, and is responsible for Drug listing activities.
Facilitate and drive the end-to-end labeling, artwork and promotional processes for the entire product portfolio.
Coordinate review, development and approval of Medical promotional and educational materials.
Responsible for initiating claim forms and working with subject matter experts to provide competent and reliable support to be used in brand messaging, advertising and other promotional material.
Manage Medical HCP relations using current KOL platform contracting (speaking/consulting), compliance, program scheduling including verification with field based programs to support and verify speaker activity (payment approvals, handling payment issues).
Provide support for Medical Affairs and Regulatory Affairs to address project needs of our brand marketing groups.
Organize, compile, and maintain all labeling and artwork related documentation, and ensures version control and compliance of filing and archiving requirements.
Monitor and track the status of labeling-related deliverables from the different functional areas, ongoing issues and activities.
Schedule and facilitate labeling and artwork project team meetings; including: preparing and managing the agenda, documenting key decisions and next steps, following-up on outstanding issues.
Drive development of annotated labeling text.
Develop the applicable labeling forms based on information provided by functional areas.
Review for completeness, consistency and accuracy the labeling and artwork documentation.
Work with artwork and graphic providers to coordinate the review and approval of the artwork components.
Lead the functional review and approval of artwork components.
Coordinate the implementation of new and updated printed packaging components.
Collaborate with internal and external functional areas and stakeholders with regards to labeling, claims, and artwork.
Responsible for the preparation, review and submission of NDC/SPL to the FDA.
Manage Drug Listing activities. Ensure that all Product Drug Listings at FDA are up-to-date and compliant.
Project management, time management and organizational skills; Ability to manage complex issues and coordinate multiple projects simultaneously; Ability to prioritize and multi-task with minimal supervision based on interactions with project team members; Excellent organizational, planning and follow-up skills. Able to meet tight timelines, efficient, detail oriented with knowledge of medical and regulatory terms, flexible and self-starting. Must have basic problem-solving skills, both from a technical and procedural perspective. Ability to multi-task projects.
Excellent proofreading/editing skills; excellent usage of the English language (spelling, grammar, and punctuation); excellent communication skills; the ability to work well under pressure and adapt to changing priorities.