Analytical SME & CMC Technical Writer
REMOTE | Analytical SME & CMC Technical Writer | 12-Month Contract | Pharmaceutical Industry We are seeking an experienced Analytical SME & CMC Technical Writer to support drug substance (DS) and drug product (DP) development programs within a fast-paced pharmaceutical environment. This role is ideal for someone with a strong background in analytical development, CMC documentation, regulatory submissions, and technical writing within biotech/pharma. Key Responsibilities:
- Support DS/DP analytical development, QC, stability programs, and control strategies
- Author/review CTD Module 3 documentation and analytical sections for global regulatory submissions
- Collaborate with internal teams and external CDMOs/CROs
- Review protocols, reports, specifications, quality agreements, and stability data
- Manage documentation workflows within Veeva RIM
Required Qualifications:
- PhD required
- 6+ years of pharmaceutical/biotech CMC and analytical development experience
- Strong experience with regulatory submissions and technical writing
- Familiarity with GMP and global regulatory guidelines (ICH, FDA, EMA, USP, EP)
- Experience supporting solid and liquid formulations
Preferred:
- Experience with IND, CTA, NDA, or MAA submissions
- Experience working with external manufacturing/testing partners
Top Skills:
- Analytical development & QC expertise
- CMC technical writing and regulatory documentation
- Strong communication and cross-functional collaboration
Additional Details:
- Fully Remote
- 12-month contract
- Interview process includes video interview + panel interview
Interested candidates are encouraged to apply with an updated resume.