Technical Writer

50% onsite required. Work schedule: Monday–Friday (normal 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 deliver on timelines for submissions and interfaces with experts in Process Development, Analytical Development, Cell Therapy Technical Operations, Quality, and Regulatory Sciences.

Responsibilities

• Co-author/author scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to 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 CTDO to identify source documents and align delivery of approved technical documents in accordance with project timelines and CTD requirements.
• Provide input and scientific oversight for content generation for Module 2.3 and 3.
• Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, and revise draft sections.
• Ensure content clarity and consistency in messaging across the 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 health authority queries for submissions.
• Track upcoming submissions and ongoing submission progress.
• Maintain submission content tracker for regulatory submissions and work with document specialists, project managers, and Reg CMC to update the tracker.
• Represent Technical 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

• Bachelor’s degree in Biology or a related discipline with a minimum of 2 years of experience.
• Familiarity and understanding of regulatory requirements and guidance pertaining to CMC documentation; 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 commonly used Microsoft Office applications (Word, Excel, SharePoint, PowerPoint).
• Experience with computer-assisted document preparation tools is 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.
• Take ownership of section formatting, language checks, and connections to other sections/tables.
• Works independently under supervision and collaborates with other team members from scientific functions, project management, and document management in cell therapy.

Travel

Occasional travel to other local New Jersey sites for larger team meetings (2–3 times per year).