Nonclinical Data Associate (SEND)

Overview:

Within AbbVie's Toxicology & Pharmacology function, the Nonclinical Data Associate will support regulatory submissions by reviewing and preparing Nonclinical Dataset Packages in accordance with FDA requirements.

Responsibilities:

• Technical preparation of datasets
  o Follow established procedures to prepare datasets for nonclinical studies in accordance with the FDA Standard for Exchange of Nonclinical Data (SEND) requirements and internal standards
  o Develop an understanding of Regulatory guidance documents used in dataset preparation
  o Capably use software and other tools to create compliant datasets and metadata (define.xml) files
  o Prepare Nonclinical Study Data Reviewer’s Guide (nSDRG) documents
• Quality control of dataset packages
  o Integrate knowledge of nonclinical study conduct to assure correct dataset output
  o Knowledgably interact with study personnel as needed to prepare, review and troubleshoot issues for dataset packages
  o Use knowledge of regulatory requirements and toxicology study conduct to resolve and/or provide rationale for validation errors and warnings
  o Communicate findings to team members and management

Basic Qualifications:

• Bachelor’s degree or equivalent experience required.
• BS in a scientific field preferred.
• 1-2 years of experience supporting nonclinical research and development in the pharmaceutical industry preferred.
• Understanding of toxicology or related nonclinical study conduct and design. GLP (or related regulatory environment) experience preferred.
• Proficient with computer systems and software.

Competencies:

• Collaboration and teamwork skills necessary for small team and internal business interactions/communications
• 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, investigation and identification of the root cause
• Works with a proactive mindset - 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 strong organizational skills
• Seeks team input when needing information, escalates issues when appropriate
• Detail oriented while understanding and acting against the “big picture”
• Ability to integrate and retain new information quickly (quick learner)
• Demonstrates ability to act as a change agent: timelines, priority shifts, system upgrades and migrations, business process improvements,

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.