Data & Quality Review I

Overview:

Business Title: Regulatory Submissions Document Reviewer

Position Title: Regulatory Submissions Document Reviewer I

Division: Consumer Products Services

Entity: Consumer Products Services/ATL/Galbraith

Location: Indianapolis, IN

Reports to: Manager

FLSA: Non-exempt

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 I is responsible reviewing 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. Responsibilities will also include bioanalytical authoring, authoring support for various regulatory submissions, and literature reviews.

Duties and Responsibilities:

It is everyone’s responsibility to live out our Values and Absolutes by Shaping a World of Trust while ensuring responsible progress.

• Provide review of nonclinical toxicology, pharmacology, and pharmacokinetic regulatory submission documents to ensure consistency, clarity, and accuracy
• Author clinical bioanalytical summaries for regulatory submissions
• 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 report literature searches for clinically-relevant safety findings
• Present team metrics in monthly meetings to managers and clients
• 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:

• Ability to search scientific literature and publications
• Possess and demonstrate excellent written and verbal communication skills
• Individual and team work ethic
• Excellent attention to detail
• Proficiency with Windows, Adobe Acrobat, Word & Excel
• Utilize higher-level math skills such as conversion in metrics
• Ability to organize and prioritize workload to meet or exceed deadlines
• Positive attitude, self-motivated, high level of engagement
• Adheres to company values

Education and Experience:

• PhD in biology or a related field.

Compensation Range: $30.00-$33.00 per hour  (e.g., 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).