Nonclinical Data Associate (SEND) G11

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

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
  • 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
  • Develop an understanding of Regulatory guidance documents used in dataset preparation
  • Capably use software and other tools to create compliant datasets and metadata (define.xml) files
  • Prepare Nonclinical Study Data Reviewer’s Guide (nSDRG) documents
• Quality control of dataset packages
  • Integrate knowledge of nonclinical study conduct to assure correct dataset output
  • Knowledgably interact with study personnel as needed to prepare, review and troubleshoot issues for 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

Basic Qualifications

• Bachelors 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,

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  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 protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html