Regulatory Affairs Coordinator, AdPromo Publishing

Lake County, IL, United States
Nov 18, 2020
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Key Responsibilities:
  • Coordinates and completes all prescription drug advertising and promotional labeling FDA submissions.
  • Publishes submissions, creating compliant submissions that can be easily reviewed by a regulatory agency.
  • Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidance. Coordinates submissions with offsite publishers.
  • Transmits submission to FDA and archives submission.
  • Executes final quality control review of promotional materials during the preparation of submissions to FDA for advisory and initial use.
  • Participates in internal team meetings, represents US/LA Submission Operations on teams as necessary, reviews and authors documents, meets timelines.
  • Plans and prioritizes workload, follows up to assure success and works to bring issues to resolution.
  • Provides support for promotional labeling systems and processes as requested.
  • Assists in the training of new personnel and in the development of department processes/policies.
  • May also be assigned to work on non-Advertising and Promotion submissions such as Safety Reports or other submission types.

  • Bachelor's degree in technical or science related discipline or related work experience
  • Preferred: 3 years in Regulatory, Quality or related area, or five years creating reports and/or regulatory submissions, working with customers in planning and compilation of reports or submissions
  • Preferred: Experience with publishing related software tools e.g. Doumentum, eCTDXPress/ISIPublisher/DocuBridge/Insight platform, ISI Tookbox, Adobe Acrobat
  • Experience in a complex and matrix environment
  • Good organizational and time management skills
  • Strong communication, both oral and written
  • Ability to innovate, analyze, understand customers' needs with minimal supervision
  • Proficient with computer systems and/or pharmaceutical software
  • Experience in pharmaceutical industry preferred
  • Past experience in prescription drug advertising/promotional labeling and/or promotional labeling submissions desired
  • Knowledge of procedures and requirements regarding prescription drug advertising and promotional materials desired

- Position level can be flexible based on experience

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.