AbbVie

Clinical Documentation Associate II


PayCompetitive
LocationChicago/Illinois
Employment typeFull-Time

What's your preference?

Apply with job updates
  • Job Description

      Req#: R00131587

      Company Description

      AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

      Job Description

      “Master File Owner” responsible for managing and ensuring inspection readiness of clinical documentation/master files. CDC representative on study team(s) with ownership of the study Trial Master File (TMF).

      Responsibilities

      List up to 10 main responsibilities for the job. Include information about the accountability and scope.

      • Ensures real-time inspection readiness of clinical documentation / TMF by performing quality control (QC) of the TMF / artifacts to ensure completeness, document quality and timeliness of upload of artifacts to the TMF.
      • Collaborates with Artifact owners; holds study team members accountable for respective sections of the TMF, reports status to study team members by providing regular status updates & facilitating/leading routine TMF "health" meetings and documents the discussion/decisions made in the TMF.
      • Develops and maintains study-specific TMF structure documentation (i.e., Expected Document List, excel trackers for paper/hybrid TMF).
      • Provides support and prepares TMF(s) for audits/inspections.
      • Contribute to (may lead) functional area continuous improvement projects and/or work streams.
      • Provide input and/or recommendations to SOPs, Work Instructions and Job Aides.
      • Complies with GCP, AbbVie SOPs and function area processes.

      Qualifications

      • Bachelor's degree required with min. 2 years relevant industry experience in clinical document management or equivalent experience.
      • Proven analytical and critical thinking skills.
      • Operates with limited oversight.
      • Good oral and written communication skills; ability to facilitate cross-functional team meetings.
      • Ability to manage several projects at the same time.
      • Competent knowledge of clinical documentation business procedures.
      • Ability to independently work in clinical documentation system.

      Key Stakeholders

      Members of Clinical Documentation Center; colleagues in Development and Global Medical Affairs responsible for contributing/owning master file artifacts.

      Additional Information

      Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

      • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

      • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

      • This job is eligible to participate in our short-term incentive programs.

      Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

      AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

      US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

      US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

      https://www.abbvie.com/join-us/reasonable-accommodations.html

  • About the company

Notice

Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000.

Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility.

An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report. NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.