Senior Scientist, Toxicology I

AbbVie; North Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie seeks a GLP Study Director to lead internally conducted toxicology studies (80%) and to monitor external sponsor studies at contract research organizations. You will ensure the highest standards of GLP quality and regulatory compliance in study conduct and reporting.

You will serve as the scientific expert during audits and contribute to filing documents for global regulatory submissions, communicating key findings effectively to teams and leadership.

Qualifications

• Experience as GLP study director in toxicology.
• Strong regulatory reporting and quality standards.
• Ability to communicate complex findings clearly.

Responsibilities

• As study director, ensures GLP quality and regulatory compliance in study conduct and reporting.
• Accounts for GLP report authorship, writing and reviewing toxicology study reports and filing components.
• Represents sponsor in audits, project teams and regulatory submissions.

Skills

GLP compliance

Toxicology

Regulatory reporting

Scientific writing

Project management

Job description

About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Company Description
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Responsibilities
Job Description
The primary responsibility of this job is to function as GLP Study Director for AbbVie internally conducted toxicology studies (80% of time) and external sponsor monitor for studies conducted at contract research organizations (

• As study director, the incumbent ensures the highest standards in quality and regulatory compliance are met in study conduct and reporting.
• Accountable for all aspects of Good Laboratory Practice (GLP) report authorship, including writing and reviewing toxicology study reports and preparing assigned components of filing documents that support submissions to global regulatory agencies for drugs in development. Serve as scientific expert for studies, during audits and on project teams, committees and other assignments. Accurately identify key scientific findings and effectively communicate findings in reports, presentations, and meetings.
• Manages study timelines against regulatory filing needs and in coordination with line function management. Demonstrate the ability to resolve key planning and study conduct issues by effectively utilizing available information and technical expertise.

Accountability/Scope:

• Responsible for representing Sponsor in all aspects of GLP compliance within assigned studies and related departmental activities.