AbbVie

Clinical Documentation Associate I & II

Employer
AbbVie
Location
Jersey City, NJ, United States
Posted
Sep 19, 2020
Ref
2006894
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 .

  • Active study team member for assigned studies.
  • Ensures real-time inspection readiness of clinical documentation by collaborating with Artifact Owners, reviewing assigned TMFs to ensure accuracy and completeness, and tracking and reporting status to study team(s).
  • Develops and updates study-specific TMF structure documentation.
  • Provides support for audits/inspections
  • Update CTMS in a contemporaneous manner.
  • Collaborates with CDC Operations colleagues.
  • Complies with GCP, AbbVie SOPs and functional area processes.
  • For assigned countries, may lead and execute study start-up activities including but not limited to:-Prepare submissions to central Ethics Committees. -Review documents and assemble packet required for IP release.


Qualifications

  • Bachelor degree or international equivalent is required
  • With at least 2 years Pharma experience or professional equivalent.
  • Demonstrates analytical and critical thinking skills.
  • Operates with limited oversight
  • Good oral and written communication skills.
  • Working knowledge of clinical documentation business procedures.


Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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.