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.

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