AbbVie

Document Writer I, Clinical Process Compliance

Employer
AbbVie
Location
North Chicago, Illinois
Posted
Dec 01, 2021
Ref
2119727
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 www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Purpose :
 

The Development Document Writer I is accountable for authoring Development's quality documents by
leveraging knowledge and expertise in writing standards and working with stakeholders to ensure the end to
end processes are well-defined and articulated clearly in alignment with AbbVie's quality document system
 

Responsibilities :
 

  • Responsible for ensuring quality document standards are applied when authoring new and updating Development quality documents.
  • Responsible for understanding AbbVie's Quality System and applying the knowledge when authoring new and updated Development's quality documents.
  • Provides internal stakeholders with the understanding of AbbVie Quality System and its practical application.
  • Responsible for processing the change control documentation within AbbVie's quality documentation management system.
  • Accountable for monitoring AbbVie quality systems documentation management system for the status of change for Development's quality documents and communicating approval status to internal stakeholders.

Qualifications

Qualifications :
 

  • Bachelor’s degree (or ex-US equivalent degree) is desired (minimum of 2+ years significant relative experience without a degree).
  • Desired to have 1-2 years of Pharma-related / clinical research related experience
  • Demonstrates analytical and critical thinking skills.
  • Possesses good communication skills and demonstrated leadership abilities and problem solving skills.
  • This is a mid-level position which supports curricula supporting clinical trial execution and will have some oversight and guidance.
  • This position will report into an Associate Director level and will have no direct reports.
  • Competent in the application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).

Significant Work Activities
Keyboard use (greater or equal to 50% of the workday)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
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.