AbbVie

R&D Tech I, Document Management

Employer
AbbVie
Location
Lake County, Illinois
Posted
Jul 28, 2021
Ref
2110314
Required Education
High School or equivalent
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.

As a member of AbbVie's Pre-Clinical Safety team, the R&D Tech I, Document Management will support the preparation of toxicology study reports, non-clinical reporting submissions, and related data management. The successful candidate will work in a dynamic and supportive team of documentation specialists and will collaborate with diverse cross-functional groups across AbbVie. Candidates should be comfortable working in a fast-paced environment with a mindset towards continuous learning and growth.

Prepare Nonclinical Documents for Regulatory Submission

  • Technical expertise
    • In-depth knowledge of MS Word and document submission system
    • High quality formatting, compilation and QC of Pathology, Toxicology, Genetic Toxicology, and other reports within specified timelines 
    • Create Virtual Document of report(s) and regulatory submission components (Module 4).
  • Content support
    • Process protocols, reports, submission documents and other documents, as assigned and on a timely basis.
    • Prepare initial drafts of Toxicology Reports, Toxicology sections of INDs and NDAs, Toxicology Tabulations, Abstracts, IND Annual Reports
    • Ensure issuance and correct distribution of all protocols and amendments
    • Knowledge of where reports and submission documents fit into regulatory submissions
    • Coordinate and assist with preparation of inventories and GLP Compliance Statements for global submissions
  • Quality Control
    • Key responsibility for drafting and quality control checks of all assigned document content within defined standards (non-scientific)
    • Creates and QCs Toxicology sections of submission planners for Regulatory submissions
    • Accountable for Quality Control checks of Regulatory submissions in eCTD Express
  • Reporting support for regulated and investigative non-clinical reports,
    • Use report template to convert study protocols to draft report
    • Collaborate with publishers to compile report
    • Route report for approval
    • Actively maintain timelines for reports and submissions by tracking timelines for submission documents, and reports and their components.  Works proactively with authors and project reps to meet deadlines
  • Other support
    • Produce finished documents in a timely and organized manner
    • Provide user testing and support for system upgrades
    • Maintain document and submission tracking for all documents
    • Routinely engages management for issue and timeline status, quality and/or content questions

Qualifications

Basic

  • HS diploma with typically 10+ years, Associates degree with typically 8+ years, or Bachelors degree with typically 6+ years of relevant experience
  • Bachelors degree and 2+ years experience in the pharmaceutical industry strongly preferred
  • Previous experience supporting preparation of submission documents preferred

Competencies

  • Ability to work independently while contributing as an effective, collaborative team member
  • Resolution oriented - uses reasoning to troubleshoot and provide possible solutions to issues regardless of origin; seeks root cause of problems at appropriate time
  • Works proactively- must be able to provide work product and results on time, accurately and consistent with expectations
  • Excellent communication skills-both verbal and written. Ability to communicate complex, technical issues clearly
  • Ability to prioritize multiple tasks/projects and apply strong organizational skills
  • Detail oriented
  • Must possess excellent interpersonal skills and ability to work with diverse teams
  • Demonstrates ability to act as a change agent: timelines, priority shifts, system upgrades and migrations, business process improvements, engages management
  • Experience with relevant software systems, scientific writing and terms, document checking, importation, and workflows in electronic submissions systems highly preferred

 


Significant Work Activities
N/A
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.