Technical writer

ZipRecruiter; New Brunswick; Hybrid; CAD 60,000 - 80,000; Full time

Job summary

A leading regulatory consulting firm is seeking a Regulatory-Technical Writer in New Brunswick to develop scientific content for regulatory submissions. The ideal candidate should have a Bachelor's degree in Biology and minimum 2 years of relevant experience. This contract role offers a pay range of $43 - $45 per hour and includes various benefits like medical coverage and 401(k).

Benefits

Medical & pharmacy coverage

Dental/vision insurance

401(k)

Employee Assistance Program (EAP)

Qualifications

• Minimum of 2 years’ experience in technical writing.
• Understanding of CMC documentation requirements.
• Familiarity with eCTD structure for regulatory submissions.

Responsibilities

• Co-author scientific content for regulatory submissions.
• Manage timelines for submission processes.
• Ensure clarity and consistency in technical documents.

Skills

Technical writing

Regulatory compliance

Attention to detail

Communication skills

Project management

Education

Bachelor’s degree in Biology or related discipline

Tools

Microsoft Word

Microsoft Excel

SharePoint

Job description

Job Description

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:

• 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 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 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 ; CMC experience required.
• Familiarity with eCTD structure for regulatory submissions is required; BLA experience is strongly.
• 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 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.

PAY RANGE AND BENEFITS:

Pay Range: $43 - $45 per hour

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, 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).

Equal Opportunity Employer: 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, , or belief,, citizenship, social or,, age, physical or mental,, veteran status, marital status, domestic partner status,, or any other status protected by the statutes, rules, and regulations in the locations where it operates.