Technical Writer – CMC Regulatory Submissions
SOKOL GxP Services
contract
Posted on:
Location Type: Hybrid
Location: New Brunswick • New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $34 - $44 per hour
Job Level
JuniorMid-Level
About the role
- Author and co-author CMC content for CTD Quality sections, ensuring alignment with regulatory strategy and scientific accuracy.
- Plan and lead submission kick-offs, managing detailed timelines, deliverables, and cross-functional collaboration.
- Coordinate and track submissions, including responses to Health Authority questions, data verification, and final dossier preparation.
- Partner with subject matter experts (SMEs) across CTDO to identify source documents, align on timelines, and deliver approved technical content.
- Ensure consistency, clarity, and accuracy of messaging across all CMC documentation.
- Review and reconcile comments with SMEs, manage revisions, and facilitate efficient comment resolution.
- Provide oversight for eCTD Modules 2.3 and 3, ensuring compliance with formatting, structure, and regulatory requirements.
- Collaborate with external partners as needed to review and finalize CTD content.
- Drive process improvements and contribute to best practices in regulatory writing and document management.
- Mentor and train team members on technical writing standards, systems, and submission processes.
Requirements
- Bachelor’s degree in Biology or a related discipline; advanced degree preferred.
- Minimum 2 years of experience in biotech or pharma, with a focus on end-to-end product development.
- Strong knowledge of regulatory requirements and guidance for CMC documentation; cell therapy CMC experience required.
- Familiarity with eCTD structure and BLA submissions strongly preferred.
- Exceptional scientific writing and editing skills with strong attention to detail.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, SharePoint); experience with document preparation tools and compliance-ready standards.
- Excellent planning, organizational, and communication skills, with the ability to manage multiple priorities in a fast-paced environment.
- Proven ability to work independently while thriving in cross-functional team settings.
Benefits
- Competitive hourly rate: $34 – $44/hr (W-2 only, no C2C)
- Hybrid schedule (50% onsite Tu – Thu; full onsite during the first month)
- 12-month contract with possible extension
- Health benefits, holiday pay, and 401(k) program
- Paid time off (PTO) and professional development support
- Employee referral bonus program
- Opportunity to contribute to high-impact projects with a leading biopharma company
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
CMC content authoringregulatory strategy alignmentsubmission managementdata verificationeCTD Modules 2.3 and 3BLA submissionsscientific writingediting skillstechnical writing standardsdocument management
Soft skills
planningorganizational skillscommunication skillsattention to detailcross-functional collaborationmentoringtrainingprocess improvementcomment resolutionindependent work