Data & Quality Review I
About The Position
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.It is everyone’s responsibility to live out our Values and Absolutes by Shaping a World of Trust while ensuring responsible progress.
Requirements
- 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
- PhD in biology or a related field.
Responsibilities
- 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Ph.D. or professional degree
Number of Employees
5,001-10,000 employees
