Regulatory Submissions Document Reviewer I

The Regulatory Submissions Document Reviewer I reviews regulatory documents for various client departments in the Consumer Products Services division. These quality reviews ensure inter- and intra-document consistency, check for typos, missing citations, references, table and figure footnotes, and calculation errors. Responsibilities also include bioanalytical authoring and support for regulatory submissions.

Day-to-day duties involve providing review of nonclinical toxicology, pharmacology, and pharmacokinetic regulatory submission documents to ensure consistency, clarity, and accuracy. Author clinical bioanalytical summaries for regulatory submissions and perform annual report literature searches for clinically-relevant safety findings. Additional tasks include presenting team metrics in monthly meetings to managers and clients.

Work closely with PhD-level scientists, communicating to review their reports for data conclusions and accuracy. Provide technical leadership, including project design, technical troubleshooting, and support. Follow guidelines set forth with clients and in company Quality, Health, Safety and Environmental policies and procedures.

Comply with clients and company management systems in accordance with appropriate regulatory agencies. Adhere to the company Quality Manual and Safety/Chemical Hygiene Plan. Take on other duties as defined by Manager, department needs, and workload.