Nonclinical Regulatory Document and Scientific Writer at American Cybersystems, Inc. in Summit, New Jersey
Posted in Other about 11 hours ago.
Job Description:
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.
-
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.
Thank you!
Mohit Vyas
Sr. Associate ? Recruitment
Mohit.Vyas@innovasolutions.com
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
Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.
