R&D Technician I

Employer
AbbVie
Location
North Chicago, Illinois, USA
Posted
Jun 28, 2018
Ref
1804603
Required Education
Bachelors Degree
Position Type
Full time

Key responsibilities Include:

  • Preparing Nonclinical Documents for regulatory submission
  • Technical expertise
  • Process protocols, reports, submission documents and other documents, as assigned and on a timely basis
  • In-depth knowledge of MS Word
  • Ensure high quality compilation and QC of Pathology, Toxicology, Genetic Toxicology, and other reports within specified timelines.
  • Create Virtual Document of report and M4 of Regulatory Submissions to assist in quick compilation completion.

Content knowledge:

  • Prepare early 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
  • Coordinates and assists with preparation of JNDA inventories and GLP Compliance Statements

Quality Control:

  • Key responsibility is drafting and quality control checks of all assigned document content within defined standards (non-scientific)
  • Accountable for Quality Control checks of regulatory documents, etc. for consistency and errors per process
  • Creates and QCs Toxicology sections of submission planners for Regulatory submissions
  • Accountable for Quality Control checks of Regulatory submissions in eCTD Express
  • 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.
  • Produce finished documents in a timely and organized manner
  • Provide support and help ensure user testing is conducted for system upgrades
  • Maintains document and submission tracking for all documents
  • Routinely engages management for issue and timeline status, quality and/or content questions

Competencies:

  • Proven ability to excel in a high paced and demanding environment
  • Experienced and facile with computer systems and software
  • 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, relentlessly seeks root cause of problems
  • Works proactively- must be able to provide services 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
  • Catch on quickly
  • Demonstrates ability to act as a change agent: timelines, priority shifts, system upgrades and migrations, business process improvements, engages management
  • Strong knowledge of scientific terminology
  • Proven ability to work with diverse teams Experience with document checking, importation and workflows in electronic submissions systems highly preferred.

Basic:
  • Bachelor of Science Degree required.
  • 2+ years experience supporting preparation of submission documents in the pharmaceutical industry required.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled