Technical Writer

Job Title: Technical Writer Location: New Brunswick, NJ - 50% Remote role Duration: 12 Months+ (Possibility of Extension) Pay rate: $44.29/Hr. On w2 Job Description: · The Technical Writer 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 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 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. · Ensures 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 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.

Created: 2025-09-23