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Senior Associate, Labeling and Promotional Submission

 
Requisition ID:  369
Location: 

Deerfield, Illinois, US

Date:  May 13, 2019
 

At Lundbeck, we believe life is too precious to be interrupted by brain disorders. Lundbeck is uncompromisingly committed to the research, development and delivery of targeted therapies for people living with significant psychiatric and neurological disorders. We pursue imaginative solutions, driven by passionate people committed to do the right thing for our patients, our company and our communities. Lundbeck strives to be a leader in depression, schizophrenia, Alzheimer's disease and Parkinson's disease. 

 

For Lundbeck, making a meaningful difference for patients is more than an aspiration; it is a commitment that shapes everything we do. Patient advocacy is at the core of who we are and motivates every individual at Lundbeck. Our engagement with the communities we serve grants us better understanding of the needs of patients and their families; and that drives us to develop innovative therapies and impactful programs for patients and caregivers.

 

Senior Associate, Labeling and Promotional Submission

SUMMARY

The Senior Associate, Labeling and Promotional Submissions will provide professional proofreading services for commercial and promotional labeling; support processing of advertising and promotional materials, including OPDP (Office of Prescription Drug Promotion) submissions; and support for initiation and renewal of state licensing.

 

ESSENTIAL FUNCTIONS

  • Proofreads drug advertising and promotional materials including electronic review system processing and labels/labeling documents
  • Supports proofreading of other regulatory documentation
  • Supports preparation and quality control of FDA form 2253 for OPDP submissions and packaging and shipping processing
  • Provides back-up support for completion of state-licensing registrations (includes both initial and renewal applications) and state-licensing file management
  • Tracks new or updated drug labels/labeling in an electronic file
  • Supports other functional areas within regulatory affairs as needed

 

REQUIRED EDUCATION, EXPERIENCE and SKILLS

  • Accredited Bachelor’s Degree
  • 3+ years proofreading experience
  • Advanced proofreading skills with excellent comprehension of medical terminology
  • Strong communication skills
  • Proficient use of MS Word, MS Excel, Adobe editing products

 

PREFERRED EDUCATION, EXPERIENCE and SKILLS

  • Accredited Bachelor’s Degree in English, Journalism or Sciences
  • 3+ years of experience in RA, R&D or health-care related industry, with at least 1 year in regulatory environment
  • Proofreading experience at a professional medical society or other pharmaceutical company
  • Experience within an electronic review system for ad/prom pieces
  • Knowledge of American Medical Association style guidelines
  • May require lifting of boxes up to 25 lbs during shipping activities, generally twice monthly

 

TRAVEL

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

 

 

Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employement 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.