Quality - Technical writer

Job Description:

The Technical Writer and Document Specialist (TW/DS) will sit within the Cell Therapy Development and Operations (CTDO) Portfolio Strategy and Operations (PSO) Pipeline Portfolio Management Office (PMO). This individual will be responsible for delivering 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. The position interfaces with experts in Process Development, Analytical Development, Cell Therapy Technical Ops, Quality, and Regulatory Sciences across CTDO. The successful candidate will work effectively in cross-functional project teams to accomplish company goals.

Primary Responsibilities:

• Co-authors/ 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 SMEs across CTDO to identify source documents, and align delivery of approved technical documents in accordance with project timelines and aligned with CTD requirements and regulatory strategy.
• 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.
• Ensures content clarity/ consistency in messaging across dossier.
• Represent Tech 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 the technical writing processes
• Collaborate with cross-functional team for effective logistical process and detailed timeline for scientific/ 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
• Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process.
• Manage the logistical process and detailed timeline for authoring, review, and data verification of regulatory submissions.
• Collaborate with external suppliers as needed for CTD content and review.
• Manage data verification documentation.
• Review and adjudicate comments in collaboration with SMEs
• Train others on procedures, systems access, and best practices as appropriate.
• Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process.
• Work independently under supervision and collaborate with other teams.

Competencies & Experiences:

• Bachelors degree or equivalent in relevant discipline with a minimum of 2 years? 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 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 regulatory Documentum software (CARA, eSub, etc.) is strongly 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.
• Take ownership of the section formatting, language check, connections to other sections/tables, etc.
• Works independently under supervision and collaborates with other team members from scientific functions, project management, document management in cell therapy, and …