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Senior Manager, Advertising and Promotion Compliance

 
Requisition ID:  761
Location: 

Deerfield, Illinois, US

Date:  Nov 22, 2019
 

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 pharmaceutical 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

Under the supervision of departmental management, the Senior Manager, Advertising and Promotion Compliance (US RA): provides regulatory advertising and promotional support for the successful lifecycle management of Lundbeck US drug products; helps ensure compliance with regulatory requirements and corporate standards; and maintains candid and positive communications with local regulatory agents for licensing partners and with regulatory staff from other regions. More specifically, this position provides regulatory labeling and promotional guidance to internal business partners as requested; executes regulatory review and approval of advertising and promotional materials to ensure consistency with product labeling, current FDA regulations, guidance documents and internal SOPs; assists with departmental regulatory training initiatives both internal and external; and provides research support concerning advertising and promotion regulations.

 

ESSENTIAL FUNCTIONS

  • Provides regulatory review of product labeling, advertising and promotional materials for accuracy and compliance with FDA regulations. Manages, reviews and represents regulatory perspective at PARC meetings to negotiate accurate, compliant and competitive final materials. Identifies risk, problem-solves, offers solutions. Manages/supports related FDA submission activities in compliance with current FDA regulations.
  • In close cooperation with regulatory agents, coordinates regulatory promotional submissions; prepares submissions in compliance with regulatory requirements and guidance documents; ensures that appropriate review and approval is obtained.
  • Provides internal and external training on departmental initiatives and for compliance purposes.
  • Assists in monitoring the external regulatory climate to inform internal customers of potential impact on long-term objectives; Represents RA at cross-functional team meetings to represent agreed-upon RA positions.
  • Assesses and improves internal promotional material review processes as appropriate to support continuous improvement and departmental efficiencies.

 

REQUIRED EDUCATION, EXPERIENCE and SKILLS

  • Accredited BS Degree
  • 5+ years of experience in RA, R & D or related area within the pharmaceutical or biotech industry
  • 2+ years direct experience in advertising and promotion
  • Demonstrated proficiency in following scientific arguments, well-established understanding of scientific data and promotional regulations as they relate to drugs and/or biologics
  • Experience in identifying regulatory risk and negotiating/resolving differences
  • Attention to detail and strong organizational skills with the ability to meet multiple deadlines
  • Demonstrated ability to work in a multi-disciplinary team
  • Excellent oral and written communication skills, including ability to articulate regulatory positions
  • High proficiency in MS Word, MS Excel and Adobe Acrobat              

 

PREFERRED EDUCATION, EXPERIENCE and SKILLS

  • Terminal Degree in a Science Field (Ph.D., PharmD)
  • Science, Chemistry, Pharmacy or related subject study/experience
  • Experience in medical information review of promotional material
  • Ability to work independently

 

TRAVEL

  • Willingness/Ability to travel ~5-10% domestically to business meetings and learning experiences.

 

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. 

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. 

An estimated 700 million people worldwide are living 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 5,000 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 late-stage development programs and our products are available in more than 100 countries. Our research center is based in Denmark and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 18.1 billion in 2018 (EUR 2.4 billion; USD 2.8 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.