Quality - Technical writer

Hybrid role requiring a minimum of 50% onsite presence. Preferred locations: Warren, Princeton Pike, or Summit West. Monday–Friday business hours.

About the role

This individual will deliver CMC documentation (dossier and supporting documents) to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application. The role requires effective collaboration across technical functions to meet submission timelines and interfaces with experts in Process Development, Analytical Development, Cell Therapy Technical Ops, Quality, and Regulatory Sciences.

Responsibilities

• Co-author/author scientific content for CTD Quality sections aligned with regulatory strategy for clinical, commercial, and life-cycle CMC regulatory submissions and responses to health authority questions, based on high-quality technical reports.
• Partner with subject-matter experts (SMEs) across CTDO to identify source documents and align delivery of approved technical documents according to project timelines and CTD requirements.
• Provide input and scientific oversight for content generation in module 2.3 and 3.
• Review and adjudicate comments, facilitate resolution, and revise draft sections.
• Ensure content clarity and consistency in messaging across the dossier.
• Represent Technical Writing and document management in cross-functional CMC teams.
• Manage the logistical process and detailed timeline for scientific and regulatory content creation for clinical, commercial, and life-cycle CMC submissions and responses.
• Assist with dossier creation and system compliance for regulatory submissions.
• Coordinate with CMC matrix team leaders to ensure timely submissions.
• Support and implement continuous process improvement initiatives.
• Mentor and train employees on technical writing processes.
• Collaborate with cross-functional teams to manage the logistical process and timeline for scientific/regulatory content creation.
• Manage the authoring, review, and data verification process for regulatory submissions.
• Collaborate with external suppliers for CTD content and review as needed.
• Manage data verification documentation.
• Train others on procedures, systems access, and best practices.
• Work independently under supervision and collaborate with other teams.

Requirements

• Bachelor’s degree or equivalent in a relevant discipline with a minimum of 2 years of experience (4–7 years for senior level).
• Cell therapy CMC experience required.
• Familiarity with eCTD structure for regulatory submissions is required; BLA experience is strongly preferred.
• Outstanding verbal and written communication skills, strong attention to detail, planning, organizational, and negotiating skills.
• Proficiency in Microsoft Office applications (Word, Excel, SharePoint, PowerPoint).
• Experience with regulatory document management software (e.g., CARA, eSub) is strongly preferred, along with proficiency in compliance-ready standards for final publication.
• Experience in biotech/pharma end-to-end product development.
• Ability to work in a fast-paced, changing team environment, prioritizing multiple tasks to meet filing deadlines.
• Ownership of section formatting, language checks, and connections to other sections/tables.