Associate Director, Promotional Review and Operations - Remote Opportunity

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs in neurology and psychiatry. Join us on our journey of growth!

SUMMARY: 

This role is responsible for leading the approval process for all Lundbeck U.S. promotional materials through the required Medical, Regulatory, and Legal review. Will oversee and manage the associated systems that regulate and ensure compliance for advertising and promotion as well as overseeing materials inventory management. This position will lead individual team members as well as work cross-functionally to create processes, manage system enhancements, develop metrics and reporting, and implement training necessary to execute on all aspects of speaker program management. This position will ensure all promotional materials are reviewed and approved in a timley manner in accordance with all internal processes and procedures. These include, leading cross functional team meetings with various levels of management; lead for managing promotional items through label updates; ensuring materials are routed for review and are approved prior to first use; developing new processes and procedures; facilitating PARC/STRC Steering Committee meetings; and owning onboarding efforts as it pertains to PARC/STRC and Veeva.

ESSENTIAL FUNCTIONS:
•    Leads cross-coordination and prioritization efforts for all PARC/STRC jobs within the US 
•    Ensures regulatory compliance of promotional materials while effectively managing business risk 
•    Ensures all logistical and operational support teams and priorities are aligned across all areas of the business as it relates to commercial execution of promotional materials and messaging
•    Monitors regulatory promotional environment by reviewing regulatory promotional guidelines and untitled warning letters to companies published by regulatory agencies. 
•    Manages activities related to promotion and advertising including maintenance and preparation for electronic submission of promotional materials to regulatory agencies. 
•    Leads the effort, with brand team members and agencies, to develop review timelines and ensures materials are submitted following submission guidelines; proactively identifying discrepancies and resolving submission errors prior to routing promotional materials for review and approval.  
•    Coordinates with internal and external partners to manage the overall workflow, process and documentation through the internal review system in accordance with promotional review and approval (PARC), and sales training review and approval (STRC).
•    Provides recommendations on phase IV clinical trial design with regard to marketing promotion possibilities of potential data/claims. 
•    Establishes and manages operational KPIs and develops associated PARC/STRC scorecards/reporting. Leads reporting and analytics regarding the review process, prioritization, label changes, launch initiatives, etc.
•    Supports planning and preparation for monthly/Quarterly PARC Steering Committee meetings.
•    Leads the team’s training and onboarding as it relates to PARC/STRC and Veeva
•    Responsible for oversight of the typesetting, printing, approval, and implementation of all promotional labeling 
•    Leads cross functional review team meetings with various levels of management, facilitates conversations which lead to resolution, proactively identifies gaps and potential issues, takes formal meetings notes, ensures proper documentation, and clearly identifies next steps for all reviews.  
•    Manages and coordinates material as it relates to a label change or product launch.
•    Oversees all internal and external training on the process for promotional review and approval (PARC), and sales training review and approval (STRC).
•    Oversees and provides direction on the inventory management of all promotional materials to ensure materials are warehoused, maintained, tracked and delivered within budget and are monitored for compliance. 
•    In conjunction with other Business Effectiveness stakeholders, develops long-term roadmap for the continued evolution of our CRM platform.
•    Continuously looks for process improvements on current and future processes to allow for growth and continued efficiency.

REQUIRED EDUCATION, EXPERIENCE, and SKILLS:
•    Accredited Bachelor’s degree
•    8+ years of direct experience in managing day-to-day responsibly of PRC/MRL pro