Scientist, Toxicology

Employer
AbbVie
Location
Lake County, Illinois, USA
Posted
Jun 28, 2018
Ref
1804611
Required Education
Bachelors Degree
Position Type
Full time

Candidate will prepare SEND datasets and nonclinical documents for regulatory submission.

Technical preparation of datasets:

  • Prepare timely, FDA compliant SEND datasets, define files and Study Data Reviewer's Guides
  • Understand and comply with Regulatory guidance documents used in dataset preparation
  • Understand and comply with FDA business rules used in dataset preparation
  • Capably use software and other tools to create compliant datasets and domains

 

Troubleshooting and quality control of dataset packages:

  • Integrate knowledge of AbbVie study conduct to assure correct dataset output
  • Knowledgably interact with study personnel as needed to prepare, review and troubleshoot dataset packages
  • Use knowledge of Regulatory requirements and Toxicology study conduct to resolve and/or provide rationale for validation errors and warnings
  • Communicate findings to team members and management
  • Prepare Study Data Reviewer's Guide
  • Manage marketing application sections during preparation period; filing team SME participant
  • Define and communicate deliverables, quality targets and timelines
  • Develop Toxicology study knowledge/ expertise
  • Stay current with changing Regulatory requirements and industry norms

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:

  • People leadership, collaboration and teamwork skills necessary for small team and external business interactions/communications
  • Understanding of Toxicology or related nonclinical study conduct and design as it relates to data in submission package. GLP (or related regulatory environment) experience preferred.
  • 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 issues
  • Gathers appropriate background quickly, seeks input of subject matter experts and management, proposes solutions
  • Experienced and facile with computer systems and software.
  • Works with a proactive mindset, prepares and communicates an action plan and potential issues - must be able to provide services and results on time, accurately and consistent with expectations
  • Must demonstrate and consistently use excellent communication skills, both verbal and written. Ability to communicate complex, technical issues clearly
  • Ability to prioritize multiple tasks/projects and strong organizational skills against management provided information
  • Seeks management input when needing information, doesn't jump to "that's the way we always do it"
  • Detail oriented while understanding and acting against the "big picture"
  • Must demonstrate and consistently use excellent interpersonal skills
  • Ability to integrate and retain new information quickly (quick learner)
  • Abile to act as a change agent: system upgrades and migrations, business process improvements, priority management

Basic:

  • Bachelor of Science Degree in Biology or related field required
  • At least five years' experience supporting nonclinical research and development in the pharmaceutical industry preferred

Equal Opportunity Employer Minorities/Women/Veterans/Disabled