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Technical writer
Job Location:
Job Location:
New Brunswick, NJ - USA
Hourly Salary:
USD 44 - 44
Hourly Salary:
Posted:
23 September 2026 (16 hours ago)
Posted:
Application Deadline:
21 December 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Innova Solutions has a client that is immediately hiring for a Regulatory- Technical writer.
Position type: Full-time- Contract
Duration: 12 Months
Location: New Brunswick NJ (50% onsite)
As a Regulatory- Technical writer you will:
The ideal candidate will have:
Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information and we will be back in touch as soon as possible.
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
PAY RANGE AND BENEFITS:
Pay Range*: $43 - $45 per hour
*Pay range offered to a successful candidate will be based on several factors including the candidates 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 50000 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:
Website:
Innova Solutions offers a referral bonus for qualified Ambassadors who refer eligible referrals. Submit referrals at and earn $250-$1000 per referral.
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 or . 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.
Thank You!
Team Innova Solutions
Position type: Full-time- Contract
Duration: 12 Months
Location: New Brunswick NJ (50% onsite)
As a Regulatory- Technical writer you will:
- Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses the health authority questions based on high quality technical reports.
- Plan and facilitate submission kick-off for clinical regulatory submissions across CTD pipeline assets.
- Manage the logistical process and detailed timeline for regulatory submissions.
- Partner with SMEs across CTD to identify source documents and align delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy.
- Provide input and scientific oversight for content generation for Module 2.3 and 3.
- Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process.
- Review and adjudicate comments in collaboration with technical SMEs facilitate comment resolution revise draft sections.
- Ensures content clarity/ consistency in messaging across dossier.
- Facilitate and manage the data verification process.
- Assist with dossier creation and system compliance for regulatory submissions
- Coordinate response authoring review and data verification to queries from HA for submissions.
- Track upcoming submissions and ongoing submission progress
- Maintain submission content tracker for regulatory submissions and work with doc specialist/PM/ Reg CMC to update tracker.
- Represent Tech Writing and Document management in cross-functional CMC teams as required.
- Collaborate and coordinate with CMC matrix team leaders to ensure timely submissions.
- Collaborate with external suppliers as needed for CTD content and review.
- Support and implement continuous process improvement ideas and initiatives.
- Train others on procedures systems access and best practices as appropriate.
- Mentor and train employees on the document management process
- Work independently under supervision and collaborate with other teams.
The ideal candidate will have:
- Required Bachelors degree in Biology or related discipline with a minimum of 2 years experience
- Familiarity and understanding of regulatory requirements and guidance pertaining to CMC documentation is preferred; CMC experience required.
- Familiarity with eCTD structure for regulatory submissions is required; BLA experience is strongly preferred.
- Outstanding verbal and writing communication skills strong attention to detail planning organizational and negotiating skills demonstrated ability for timely delivery.
- Proficiency in commonly used Microsoft Office applications (Word Excel SharePoint PPT) is required.
- Experience with computer-assisted document preparation tools is preferred along with proficiency in compliance ready standards for final publication.
- Experience in biotech/pharma e2e product development required. Must be capable of working in a fast-paced changing team environment prioritizing multiple tasks to meet filing deadlines.
Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information and we will be back in touch as soon as possible.
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
PAY RANGE AND BENEFITS:
Pay Range*: $43 - $45 per hour
*Pay range offered to a successful candidate will be based on several factors including the candidates 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 50000 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:
- Named One of Americas Best Employers for New Grads by Forbes (2024)
- Named One of the Best Companies to Work For by U.S. News & World Report (Private Companies List 2024-2025)
- One of the Largest IT Staffing Firms in the US Ranked #3 by Staffing Industry Analysts (SIA 2024)
- One of the Largest Staffing Firms in the US Ranked #13 by Staffing Industry Analysts (SIA 2024; includes Innova Solutions Volt & HireGenics)
- Named One of the Top Ten Private Companies in Atlanta by the Atlanta Business Chronicle (2023)
- One of the Largest Certified Minority Business Enterprises (MBEs) in the United States (NMSDC 2024)
- AWS Advanced Tier Services Partner with 100 certifications
Website:
Innova Solutions offers a referral bonus for qualified Ambassadors who refer eligible referrals. Submit referrals at and earn $250-$1000 per referral.
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 or . 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.
Thank You!
Team Innova Solutions
