Nonclinical Data Associate SEND

Within AbbVies Toxicology Sciences function the Nonclinical Data Associate will support regulatory submissions by preparing and reviewing 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.
  • Demonstrate a thorough understanding of the principles presented in regulatory guidance documents as applicable to SEND dataset submission.
  • 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 datasets
  • Assure correct dataset standardization and resolve nonconformances using knowledge of nonclinical studies and SEND standards.
  • Collaborate crossfunctionally to confirm information and resolve issues.
  • Communicate findings to internal/external partners and management as appropriate.
• Regulatory Intelligence
  • Maintain awareness of regulatory requirements pertaining to the submission of nonclinical data to regulatory authorities.
  • Implement process changes to comply with evolving requirements.

Qualifications :

Qualifications:

Basic Qualifications

• Bachelors Degree with typically 3 years experience or Masters Degree. 
  • Degree in a scientific field preferred
• 3 years of experience in SEND preferred.
• Participation in industry working groups (e.g. CDISC PHUSE) preferred.
• Experience supporting GLPregulated nonclinical pharmaceutical studies preferred.
• Proficient with computer systems and software.

Competencies

• Collaboration and teamwork skills necessary for 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 verbal and written communication skills. 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 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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