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Senior Associate, Labeling

 
Requisition ID:  626
Location: 

Deerfield, Illinois, US

Date:  Oct 23, 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

The Senior Associate, Labeling, US Regulatory Affairs provides support to the Director of Regulatory Affairs, Labeling to manage and implement Lundbeck labeling projects and ensure labeling compliance, documentation and timely execution to meet business needs. This role will also provide departmental backup support, as trained.

 

ESSENTIAL FUNCTIONS

  • Assists with labeling development, including research, text development, QC/compliance review, preparation for submission and internal communication.
  • Maintains labeling master files, change logs and ensures labeling tracking and archiving follow-through
  • Organizes labeling materials for internal review (e.g.,F-1027, F-1031, Divisional review, LPLC), coordinates review processing and communicates results.
  • Provides Central Labeling Committee (CLC) and other labeling meetings with administrative and document support.
  • Initiates post-approval labeling workflow, including website posting, master file hand-off and internal communication; maintains web‐based labeling.
  • Compiles and organizes RA Labeling input for post-market reports (e.g., Annual Reports, PSUR/PBRER, PNOC etc.).
  • Assists in the development of regulatory labeling procedures and SOPs.

 

REQUIRED EDUCATION, EXPERIENCE and SKILLS

  • Accredited Bachelor’s Degree
  • 3+ years of experience in Regulatory Affairs, R&D or related area within the pharmaceutical, medical device or biotech (healthcare) industry
  • Working knowledge of U.S. labeling regulations
  • Strong organizational skills and attention to detail
  • Ability to manage multiple tasks/projects; ability to work semi-independently
  • Good interpersonal and communication skills (verbal and written)
  • Proficiency in MS Word, MS Excel and Adobe Acrobat

 

PREFERRED EDUCATION, EXPERIENCE and SKILLS:

  • Accredited degree in life science related field, (i.e., chemistry, pharmacy or relevant area)
  • 1+ year direct regulatory affairs drug labeling experience

 

TRAVEL

  • Willingness/Ability to travel on limited basis if needed.

 

 

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.