AbbVie Scientist, Toxicology in Lake County, Illinois
USA, Illinois, Lake County
Research & Development
Candidate will prepare SEND datasets and nonclinical documents for regulatory submission.
Technical preparation ofdatasets:
Prepare timely, FDA compliant SEND datasets, definefiles and Study Data Reviewer’s Guides
Understand and comply with Regulatory guidancedocuments used in dataset preparation
Understand and comply with FDA business rules used indataset preparation
Capably use software and other tools to createcompliant datasets and domains
Troubleshooting andquality control of dataset packages:
Integrate knowledge of AbbVie study conduct to assurecorrect dataset output
Knowledgably interact with study personnel as needed toprepare, review and troubleshoot dataset packages
Use knowledge of Regulatory requirements and Toxicologystudy conduct to resolve and/or provide rationale for validation errorsand warnings
Communicate findings to team members and management
Prepare Study Data Reviewer’s Guide
Manage marketing application sections duringpreparation period; filing team SME participant
Define and communicate deliverables, quality targetsand timelines
Develop Toxicology study knowledge/ expertise
Stay current with changing Regulatory requirements andindustry norms
Process protocols, reports,submission documents and other documents, as assigned and on a timelybasis
In-depth knowledge of MS Word
Ensure high quality compilationand QC of Pathology, Toxicology, Genetic Toxicology, and other reportswithin specified timelines.
Create Virtual Document ofreport and M4 of Regulatory Submissions to assist in quick compilationcompletion.
Prepare early drafts ofToxicology Reports, Toxicology sections of INDs and NDAs, ToxicologyTabulations, Abstracts, IND Annual Reports.
Ensure issuance and correctdistribution of all protocols and amendments
Knowledge of where reports andsubmission documents fit into regulatory submissions
Coordinates and assists withpreparation of JNDA inventories and GLP Compliance Statements
Key responsibility is draftingand quality control checks of all assigned document content within definedstandards (non-scientific)
Accountable for Quality Controlchecks of regulatory documents, etc. for consistency and errors perprocess
Creates and QCs Toxicologysections of submission planners for Regulatory submissions
Accountable for Quality Controlchecks of Regulatory submissions in eCTD Express
Actively maintain timelines forreports and submissions by tracking timelines for submission documents,and reports and their components. Works proactively with authors andproject reps to meet deadlines.
Produce finished documents in atimely and organized manner
Provide support and help ensureuser testing is conducted for system upgrades
Maintains document andsubmission tracking for all documents
Routinely engages managementfor issue and timeline status, quality and/or content questions
People leadership, collaboration andteamwork skills necessary for small team and external businessinteractions/communications
Understanding of Toxicology or relatednonclinical study conduct and design as it relates to data in submissionpackage. GLP (or related regulatory environment) experience preferred.
Ability to work independently whilecontributing as an effective, collaborative team member
Resolution oriented- uses reasoning totroubleshoot and provide possible solutions to issues regardless oforigin, relentlessly seeks root cause of issues
Gathers appropriate backgroundquickly, seeks input of subject matter experts and management, proposessolutions
Experienced and facile with computersystems and software.
Works with a proactive mindset,prepares and communicates an action plan and potential issues - must beable to provide services and results on time, accurately and consistentwith expectations
Must demonstrate and consistently useexcellent communication skills, both verbal and written. Ability tocommunicate complex, technical issues clearly
Ability to prioritize multipletasks/projects and strong organizational skills against managementprovided information
Seeks management input when needinginformation, doesn’t jump to "that’s the way we always do it"
Detail oriented while understandingand acting against the "big picture"
Must demonstrate and consistently useexcellent interpersonal skills
Ability to integrate and retain newinformation quickly (quick learner)
Abile to act as a change agent: systemupgrades and migrations, business process improvements, prioritymanagement
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