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Regulatory Document and Scientific Writer
2 months ago
Duration: 12 months contract
Job Description:
Strong background in nonclinical Pharmacokinetics and experience with Global Health Authority interactions
Experience reviewing regulatory documents, DMPK and BA reports, and non-GLP/GLP data and notebooks
Pharmaceutical/biotech industry experience of >5 years
Experience:
Partner with Drug Metabolism and Pharmacokinetic (DMPK) and Bioanalytical (BA) Subject Matter Experts (SMEs) to author, review and track regulatory documents. Including, but not limited to, INDs, CTAs, NDAs, BLAs, IBs, Pediatric Investigative Plans and regular updates of such documents.
Regulatory submissions will span across all therapeutic areas (cancer, immunology, neurology etc.) and all modalities, including small molecule, large molecule, and cell therapies. Candidates will support multiple drug development programs. Drug development programs are global, so candidates will work on programs intended for US, EU, Japan and other world markets.
Assist with quality review of DMPK reports that are generated by DMPK scientists by fully reviewing the raw data outputs/electronic notebooks and ensuring validity and quality of reported data in the reports, in addition to reviewing DMPK regulatory documents, editing of nonclinical study reports for regulatory acceptance and adherence to company templates, SOPs, DMPK/BA methods, work practices and FDA GLPs, as applicable.
Skills:
Regulatory drug development experience of >5 years
Experience with CTD documents and nonclinical study reports for submission to global regulatory agencies.
A strong knowledge of DMPK/BA methods, data interpretation and terminology is necessary.
Education:
Bachelor’s degree in chemistry, Biology or related science
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Recruiter Details:
Name: Varshith
Email: varshith@ustechsolutionsinc.com
Internal Id: 24-17339
