Nonclinical Data Associate SEND G11

Within AbbVies 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 Reviewers 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

Qualifications :

Basic Qualifications

• Bachelors degree or equivalent experience required.
• BS in a scientific field preferred.
• 12 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

Additional Information :

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

• 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 shortterm incentive programs. 

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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 AbbVies 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.

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