Scientist l, Regulatory Documentation
- Employer
- AbbVie
- Location
- Irvine, California
- Start date
- May 31, 2023
View more
- Discipline
- Regulatory, Regulatory Affairs, Science/R&D, Biotechnology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
This role resides in the documentation team under the Local Delivery and Safety Translation Sciences (LDSTS) team. This role is responsible for generating templates, tables and figures, and prepare study reports for Local Delivery Translational Sciences (LDTS) and LDSTS teams. He/She will work with program representatives to establish timelines and coordinate activities to meet timely completion of documents in support of regulatory submissions.
The Scientist I, in collaboration with LDTS and LDSTS members, will prepare, review, and format documents, study protocols, and study reports with high quality and as needed, in accordance with electronic submission requirements. This role is also responsible for performing detailed QC of data in reports, and assisting with formatting and quality check of nonclinical sections of regulatory documents (INDs, CTDs, IBs, and others).
He/she will issue study numbers to personnel in an accurate and timely fashion and provide basic system support to personnel regarding the use of the Electronic Study Schedule (ESS) and the Global Study Schedule.
In addition, the incumbent will serve as LDTS/LDSTS liaison to the Regulatory Affairs Operations & Medical Writing group to support the establishment of new processes and systems.
The individual must operate with minimal supervision. In addition to a scientific background, this position requires familiarity with Windows-based platforms, comfort working in a computerized environment, and ability to learn electronic databases and enterprise management software. Excellent oral and written communication skills are required.
Responsibilities
- Assists LDTS and LDSTS staff with preparation of contributing and final reports, completing assignments. Assure reports meet departmental standards for formatting, consistency, and adherence to AbbVie Styles. Works with study personnel to generate tables and assemble reports that accurately and precisely describe study data. Coordinates publication and review of LDTS and LDSTS reports and documents.
- Common Technical Documents (CTD) tabular summary templates for reports and regulatory submissions. Performs submission QC for format and accuracy of content, and performs technical QC on published submissions. Good understanding of requirements for nonclinical modules of the eCTD.
- Facilitates and coordinates assembly, including timelines, of documents for regulatory submissions globally.
- Assists in the maintenance of the GLP and Non-GLP study schedule. Issues study and report numbers.
- Assists in maintaining regulatory and training records and documents for study personnel. Electronically distributes study protocols and protocol amendments to study personnel for documentation that they have been read & understood, as requested.
- Facilitates formatting, editing, and reviewing departmental procedures (SOPs) for approval by management. Manages and maintains associated forms and tracking lists for all of LDSTS and LDST.
- Serves as a back-up local system administrator (LSA) for key systems used within or by LDTS and LDSTS.
- Supports LDTS and LDSTS document administration using laboratory information management systems (LIMS, e.g., Provantis) to generate templates and tables for topline data and study reports.
- Supports departmental SharePoint sites.
- Works with LDST and LDSTS staff to produce protocol and report templates for various document types utilizing automated and/or manual data collections systems.
Qualifications
- Bachelor’s Degree or equivalent education with typically 5 years of relevant experience, or Master’s Degree or equivalent education with typically two years of relevant experience.
- Prior experience in a research or pharmaceutical environment.
- Theoretical and practical knowledge to carry out the job functions.
- Excellent oral and written communication skills.
- Proficiency with standard Windows applications and data entry/management.
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.
Company
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, and YouTube.
Stock Symbol: ABBV
Stock Exchange: NYSE
- Website
- http://www.abbvie.com/
- Phone
- 1-800-255-5162
- Location
-
1 North Waukegan Road
North Chicago
Illinois
60064
US
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