Nonclinical Regulatory Document and Scientific Writer

Innova Solutions is immediately hiring for a Nonclinical Regulatory Document and Scientific Writer Position Type: Contract Duration- 12 Months Location- New Brunswick, NJ As a Regulatory Document and Scientific Writer, you will: 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 Organization, as assigned. The ideal candidate would possess: 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 are 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. Excellent scientific writing, strong QC review skills, and verbal communication skills required. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW. Thank you Mohit Vyas Sr. Associate ? Recruitment PAY RANGE AND BENEFITS: Pay Range: $55-$58 per hour. Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields. Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) ClearlyRated® Client Diamond Award Winner (2020) One of the Largest Certified MBE Companies in the NMSDC Network (2022) Advanced Tier Services partner with AWS and Gold with MS Website: Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discriminatioTo view the full job description, click here

Created: 2024-11-02