Nonclinical Regulatory Document and Scientific Writer_

Job Title: Nonclinical Regulatory Document and Scientific WriterLocation: New Brunswick, NJType: ContractOverviewLeading pharmaceutical company looking for a Nonclinical Regulatory and Scientific Writer. Ideal candidates should have 5+ years of experience with CTD documents and nonclinical study reports.Responsibilities+ 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. Ability to re-prioritize QC workloads quickly when needed, while meeting all necessary timelines.+ Assist in addressing Health Authority questions pertaining to DMPK and BA with the SMEs and Regulatory representatives.+ Determine and manage document timelines through authoring, review cycles and on time completion.+ Attend department group meetings for tracking and management of upcoming needs for nonclinical documentation.+ Understand the impact of DMPK/BA and interdependencies with other functional teams within the enterprise including Pharmacology, Toxicology, Clinical and Regulatory disciplines.+ Other duties related to the above within company, as assigned.Requirements+ 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.+ Exceptional project management and organizational skills to be flexible and adaptable to changing project priorities and work assignments.+ Strong interpersonal skills, be a team player, be able to self-advocate and willing to work in an environment where individual initiative and accountability are required.+ Careful attention to detail.+ Excellent scientific writing, strong QC review skills, and verbal communication skills required.+ Robust PC experience:+ Training on in-house document repository system will be provided.+ Microsoft Office Suite experience required including Microsoft Word, Excel, and Outlook.BenefitsSystem One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.