What are the responsibilities and job description for the Regulatory Submissions Document Reviewer (PhD) - Indianapolis, IN position at Bureau Veritas Group?
Overview :
Position Title : Regulatory Submissions Document Reviewer (PhD)
Business Title : Regulatory Submissions Document Reviewer (PhD)
Entity : Consumer Products Services Division
Department : ATL
Location : Indianapolis, IN (Remote)
Reports to : Manager
FLSA : Non-Exempt
Compensation Range : $30.00-$32.00 per hour ( ., the job posting is not necessarily reflective of actual compensation that may be earned, and actual compensation is subject to variation due to such factors as locations, education, experience, and skillset).
Hours Worked : Typically, Monday through Friday, forty-hours per week.
However, must be flexible to meet the needs of the department and complete other projects as assigned.
Position Summary :
The Regulatory Submissions Document Reviewer is responsible for reviewing nonclinical regulatory documents for various client departments. These quality reviews check for inter- and intra-document consistency, check for typos and missing citations, references, table and figure footnotes, and check for calculation errors.
Duties and Responsibilities :
- Complete Quality Review to ensure consistency and accuracy within and across nonclinical regulatory submission documents.
- Provide technical leadership, which could include project design and technical troubleshooting and support.
- Communicate and work with PhD level scientists and review their reports for data conclusions and accuracy.
- Perform annual review literature searches.
- Assist in writing nonclinical sections in the regulatory documents.
- Follow the guidelines set forth with clients and in the company Quality, Health, Safety and Environmental policies and procedures
- Comply with clients and company management systems in accordance with appropriate regulatory agencies
- Follow the guidelines set forth by clients in the company Quality Manual and Safety / Chemical Hygiene Plan
- Other duties as defined by Manager, department needs and workload.
Skills & Proficiencies :
Education and Experience :
An equivalent combination of education and experience may be accepted in lieu of above.
Salary : $30 - $32
