Job Title : Technical Writer and Document Analyst
Location : Warren, NJ (Hybrid)
Job Description :
Join our Cell Therapy Development Operations and Services team as a Technical Writer & Document Analyst. You'll be responsible for creating CMC documentation to support the regulatory strategy for the Cell Therapy clinical portfolio.
This role involves collaborating with various technical functions to meet submission deadlines and working closely with experts in Process Development, Analytical Development, Manufacturing Sciences and Technology, Operations, Quality, and Regulatory Sciences.
Key Responsibilities :
- Draft scientific content for CTD Quality sections and responses to health authority questions
- Collaborate with SME organizations to identify source documents and negotiate delivery of approved technical documents
- Liaise with external suppliers for CTD content and review
- Oversee scientific content generation for Quality modules 2 and 3
- Review and resolve comments, revise draft sections to ensure content clarity and consistency
- Coordinate with CMC matrix team leaders to ensure timely submissions
- Represent clinical technical writing on cross-functional CMC teams
- Support and implement continuous process improvement ideas and initiatives
- Mentor and train employees on the technical writing processes
Skills Required :
- Bachelor’s degree or equivalent in relevant discipline with a minimum of 2 years’ experience
- Familiarity with eCTD structure for regulatory submissions
- Proficiency in Microsoft Office applications (Word, Excel, SharePoint, PPT)
- Experience with regulatory documentum software (CARA, eSub, etc) is preferred
- Experience in biotech / pharma development is preferred
- Technical Writing experience in biotech / pharma is preferred
About SSi People :
With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team.
Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly.
More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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