Technical writer

Innova Solutions Inc; New Brunswick (NJ); Ibrido; USD 59.000 - 62.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical & pharmacy coverage

Dental/vision insurance

401(k)

HSA/FSA

Life Insurance

Pet Insurance

Disability insurance

Pre-paid legal

Sick time

Paid leaves

EAP

Descrizione del lavoro

Innova Solutions has a client immediately hiring for a Regulatory-Technical Writer in New Brunswick, NJ (50% onsite). This full-time contract role spans 12 months and pays $43–$45 per hour.

Responsibilities include co-authoring CTD content, coordinating submission kick-offs, managing timelines, and providing scientific oversight for Module 2.3 and 3, with an emphasis on regulatory strategy and data verification. Strong knowledge of eCTD and CMC is preferred.

Competenze

• Bachelor's degree in Biology or related discipline required.
• Strong written/verbal communication skills and attention to detail.
• Familiarity with regulatory guidance for CMC documentation preferred; CMC experience required.

Mansioni

• Co-authors scientific content for CTD quality sections aligned with regulatory strategy.
• Plan and facilitate submission kick-off for clinical regulatory submissions.
• Manage the logistical process and detailed timeline for regulatory submissions.
• Coordinate response drafting and data verification for HA queries.

Conoscenze

Regulatory writing

Verbal communication

Microsoft Office

eCTD familiarity

Formazione

Bachelor's degree in Biology or related discipline

Strumenti

eCTD structure

Descrizione del lavoro

Job Details

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)

Responsibilities

• 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.

Requirements

• Required Bachelor's 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.

Benefits & Pay

Pay Range*: $43 - $45 per hour

• 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

• Named One of America's 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

Equal Opportunity Statement

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 [e-mail] or [phone]. 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.

Contact

Website: https://www.innovasolutions.com/

Thank You! Team Innova Solutions