Nonclinical Regulatory Document and Scientific Writer
Job Description
R&D Partners is seeking to hire a Nonclinical Regulatory Document and Scientific Writer in New Brunswick, NJ.
Your main responsibilities as a Nonclinical Regulatory Document and Scientific Writer:
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.
What we are looking for in a Nonclinical Regulatory Document and Scientific Writer:
At minimum, a Bachelor s degree in Chemistry, Biology or related science with a strong background in DMPK and BA including knowledge of the FDA GLPs.
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.
Strong analytical and problem-solving skills, with the ability to manage multiple projects and teams simultaneously.
Why Choose R&D Partners?
As an employee, you have access to a comprehensive benefits package including:
Medical insurance PPO, HMO & HSA
Dental & Vision insurance
401k plan
Employee Assistance Program
Long-term disability
Weekly payroll
Expense reimbursement
Online timecard approval
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal-opportunity employer.