Quality - Technical writer

About the role

This position sits within the Cell Therapy Development and Operations (CTDO) Portfolio Strategy and Operations (PSO) Pipeline Portfolio Management Office (PMO). The Technical Writer and Document Specialist 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. This 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 Ops, Quality, and Regulatory Sciences across CTDO.

Responsibilities

• Co-author/authors 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 in accordance with project timelines and CTD requirements.
• Provide input and scientific oversight for content generation for modules 2.3 and 3.
• Review and adjudicate comments, facilitate comment resolution, and revise draft sections.
• Ensure content clarity and consistency in messaging across 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 regulatory submissions and responses to health authority questions.
• 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 ideas and initiatives.
• Mentor and train employees on technical writing processes.
• Collaborate with cross-functional teams for effective logistical processes and detailed timelines for scientific/regulatory content creation.
• Manage data verification documentation and review comments in collaboration with SMEs.
• Train others on procedures, systems access, and best practices as appropriate.
• Work independently under supervision and collaborate with other teams.
• Plan and manage logistics of regulatory submissions and facilitate submission kick-off for clinical regulatory submissions across CTD pipeline assets.
• Set up submission content tracker for regulatory submissions and work with document specialists, project managers, and Regulatory CMC to maintain the tracker.
• Track upcoming submissions and ongoing submission progress.
• Coordinate response authoring, review, and data verification to health authority queries for submissions.
• Interact and facilitate submission-related meetings with Contract Manufacturing Organizations (CMOs).
• Represent Technical Writing & Document Management (TW&DM) in cross-functional team meetings.

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.
• Experience in biotech/pharma end-to-end product development required.
• Must be capable of working in a fast-paced, changing team environment, prioritizing multiple tasks to meet filing deadlines.
• 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) is required.
• Experience with regulatory Documentum software (CARA, eSub, etc.) is strongly preferred, along with proficiency in compliance-ready standards for final publication.