Associate Scientist, I
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Job Location:
North Chicago, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
16 days ago
Vacancies:
1 Vacancy
Job Summary
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 CDISC 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 () 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 :
- Bachelors degree or equivalent experience required.
- Proficient with computer systems and software.
Preferred Qualifications:
- 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.
- Experience with SEND and SDTM data sets
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 short-term 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Laboratory Experience
- ELISA
- Immunoassays
- Transfection
- Mammalian Cell Culture
- Suspension Experience
- Biochemistry
- Assays
- cGMP
- Cell Culture
- Molecular Biology
- Flow Cytometry
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
