Technical Writer

Job Duration: 12 Months+ Possible Extension Shift: Mon-Friday(normal business hours) Job Description The Technical Writer and Document Specialist (TW/DS) will sit within the Cell Therapy Development (CTD) Project and Portfolio Management Office (PMO). This individual will be responsible for delivering CMC documentation (dossier and supporting documents) to support the regulatory strategy for a late-stage clinical cell therapy program. 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 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. 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 to project timelines and aligned with CTD requirements and regulatory strategy. Provide input and scientific oversight for content generation 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. Ensure 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 submission 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. Bachelor’s degree or equivalent in Biology or related discipline with a minimum of 2 years’ experience (4-7 years for senior level). Familiarity and understanding of regulatory requirements and guidances pertaining to CMC documentation is preferred; Cell therapy CMC experience required. Familiarity with eCTD structure for regulatory submissions is required; BLA experience is strongly preferred. Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required. Experience with computer-assisted document preparation tools is preferred along with proficiency in compliance ready standards for final publication. Experience in bio tech/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. Works independently under supervision and collaborates with other team members from scientific functions, project management, document management in cell therapy and GPS organization. #J-18808-Ljbffr Integrated Resources