CMC Technical Writer- Cell Therapy (Hybrid- New Brunswick, NJ OR Lawrenceville, NJ)

CMC Technical Writer

• Cell Therapy (Hybrid
• New Brunswick, NJ OR Lawrenceville, NJ) (Lawrenceville, NJ, 08648), (New Brunswick, NJ, 08901) | 05/13/26 Easy Apply Share Job Job Description CMC Technical Writer
• Cell Therapy (Hybrid
• New Brunswick, NJ/Lawrenceville, NJ) We are seeking a CMC Technical Writer
• Cell Therapy for our global pharmaceutical client.

You will sit within the Cell Therapy Development (CTD) Project and Portfolio Management Office (PMO) and 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. This is a 40-hour per-week, 12-month contract (extensions possible), 50% onsite role at the client's office either in New Brunswick, NJ Or Lawrenceville, NJ This is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered.

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 with 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. Maintain submission content tracker for regulatory submissions and work with doc specialist/PM/ Reg CMC to update tracker. Track upcoming submissions and ongoing submission progress 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

REQUIREMENTS

2+ years' experience in Technical Writing specifically for Regulatory CMC documentation within the pharmaceutical or biotechnology industry. Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required. Strong attention to detail, planning, organizational and negotiating skills, demonstrated ability for timely delivery. Familiarity and understanding of regulatory requirements and guidance pertaining to CMC documentation is preferred Familiarity with eCTD structure for regulatory submissions is required; BLA experience is strongly preferred. Experience with computer-assisted document preparation tools is preferred along with proficiency in compliance ready standards for final publication. Take ownership of the section

• formatting, language check, connections to other sections / tables. Bachelor's degree or equivalent in Biology or related discipline. Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the CMC Technical Writer
• Cell Therapy (Hybrid
• New Brunswick, NJ/Lawrenceville, NJ) role).

Please feel free to forward this project opening to others who may be interested. Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation:

 $40/hr.

• 41.

95/hr. #LI-SW1