CMC Technical Writer Job at Integrated Resources, Inc ( IRI ) in New Brunswick

Job Title : CMC Technical Writer

Location : New Brunswick, NJ – Hybrid (50% onsite required)

Duration : 12 months+ with high likelihood of extension for the right candidate.

Cash Pay Range : $40.00 / hr – $45.00 / hr (based on skills and experience)

Base Pay Range : $40.00 / hr – $45.00 / hr

Job Description

The Technical Writer will sit within the Cell Therapy Development and Operations Portfolio Strategy and Operations Pipeline Portfolio Management Office. 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. The role requires effective collaboration across technical functions to deliver on timelines for submissions.

Primary Responsibilities

• Co-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 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.
• Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, revise draft sections.
• Ensure content clarity and 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 and 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.

Qualifications & Experience

Travel

Occasionally to other local NJ sites for larger team meetings (2‑3 times a year).

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