Associate Director, Promotional Review and Operations

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 processes in the pharmaceutical industry
• Proficiency in Veeva PromoMats
• Excellent organization and customer support skills
• Strong verbal and written communication skills with ability to interface with all levels of Lundbeck employees project teams external partners vendors customers agencies and affiliates.
• High level of attention to detail
• Ability to influence others to accept practices and approaches.
• Conflict resolution and negotiating skills
• Ability to manage large projects and processes with limited oversight from manager
• Coaching reviewing and delegating work individuals
• Highly proficient in managing multiple projects with varying degrees of complexity to timelines
• Working knowledge of FDA guidelines and laws which govern advertising and promotion in the pharmaceutical industry

PREFERRED EDUCATION EXPERIENCE and SKILLS:
• Veeva PromoMats Admin experience strongly preferred
• Pharmaceutical marketing or sales experience preferred
• Cross functional project management experience specifically related to promotional materials in a regulated industry
• Experience working within a commercial organization
• Experience typesetting and implementing labeling into promotional materials
• At least 3 years of people management experience (contractor or FTE)

TRAVEL:
• Willingness/Ability to travel up to 10% domestically. If based remotely additional travel will be required to Deerfield IL. International travel may be required.

The range displayed is a national range and if selected for this role may vary based on various factors such as the candidate's geographical location qualifications skills competencies and proficiency for the role. Salary Pay Range: $170000 - $200000 and eligibility for a 20% bonus target based on company and individual performance and eligibility to participate in the company's long-term incentive plan. Benefits for this position include flexible paid time off (PTO) health benefits to include Medical Dental and Vision and company match 401k. Additional benefits information can be found on our site . Applications accepted on an ongoing basis.

#LI-Remote #LI-CP1

Why Lundbeck

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health family and everyday life. Information regarding our benefit offering can be found on the U.S. career site .

Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If because of a disability you need a reasonable accommodation for any part of the application process please visit the U.S. career site .

Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race color religion sex sexual orientation gender identity age national origin disability protected veteran status and any other characteristic protected by law rule or regulation. Lundbeck participates in E-Verify .

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About Lundbeck

Lundbeck is a biopharmaceutical company focused exclusively on neuroscience with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.

As a focused innovator we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few if any treatment options.

Our goal is to create long-term value and make a positive contribution to people and societies everywhere we operate. We are committed to fighting stigma and discrimination and we act to improve health equity for the people we serve and the communities we are part of.

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About Lundbeck

Lundbeck is a biopharmaceutical company focused exclusively on neuroscience with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.

As a focused innovator we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few if any treatment options.

Our goal is to create long-term value and make a positive contribution to people and societies everywhere we operate. We are committed to fighting stigma and discrimination and we act to improve health equity for the people we serve and the communities we are part of.

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