Senior Manager, Approval Process - Promotional Materials

Employer
Lundbeck
Location
Deerfield, IL, United States
Posted
Jan 29, 2021
Ref
1625
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with a U.S. home office in Deerfield, Ill., Lundbeck is the only global biopharmaceutical company focused solely on brain diseases. Our legacy in neuroscience goes back seven decades and we have a long heritage of innovation. Lundbeck has developed and commercialized some of the world's most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders. Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep and productive pipeline, and we continue to bring forward symptomatic therapies to help people live better lives, while simultaneously pursuing disease-modifying treatments.

SUMMARY:

The purpose of the Senior Manager, Approval Process-Promotional Materials is to lead the approval process for all promotional materials through the Medical, Regulatory, Legal review and manage the associated systems that regulate and ensure compliance for advertising and promotion. This position will be the lead for cross-product coordination and prioritization ensuring all promotional materials are reviewed and approved in a timely 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 approved prior to first use; developing new processes and procedures; assisting in PARC/STRC Steering Committee meetings; and owning onboarding efforts as it pertains to PARC/STRC and Veeva. This position supports Lundbeck North America (US and Canada).

ESSENTIAL FUNCTIONS:
  • Manages/leads cross-coordination and prioritization efforts for all PARC/STRC jobs within the US
  • Establishes and manages operational KPI's, and develops associated PARC/STRC scorecards/reporting
  • Supports planning and preparation for monthly/Quarterly PARC Steering Committee meetings
  • Manages PARC/STRC processes daily health. Leads reporting and analytics regarding the review process, prioritization, label changes, launch initiatives, etc.
  • Liaison for Canada Veeva PromoMats; trouble shoot process and system issues
  • 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 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).
  • 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. Leads cross functional meetings. Creates and maintains master promotional item list. Ensures timelines are met, etc.
  • Oversees all internal and external training on the process for promotional review and approval (PARC), and sales training review and approval (STRC).
  • Provides strategic direction and support in the development of new promotional materials as it relates to the approval process, production, warehousing and distribution.
  • 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
  • 6+ years of direct experience in managing day-to-day responsibilities 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
  • Conflict resolution and negotiating skills
  • Highly proficient in managing multiple projects 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
  • 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


TRAVEL
  • Willingness/Ability to travel up to 15% domestically. International travel may be required.


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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Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.

Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases - we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind

Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com, and connect with us on Twitter at @Lundbeck and via LinkedIn.