Remote CMC Technical Writer

Job Title: Analytical SME & CMC Technical Writer

Location: Remote - must be able to work EST hours

Rate: $55.00/hr

Duration: 1-year contract to start

Job Description:

We are seeking an experienced Analytical Subject Matter Expert (SME) and CMC Technical Writer to support external drug substance (DS) and drug product (DP) development programs within External Alternative CMC development (EACD).

This contract role combines deep expertise in DS/DP analytical development and quality control with demonstrated familiarity with the Veeva RIM system and technical writing capabilities to support documentation and global regulatory submissions (e.g., IND, CTA, NDA/MAA). You will collaborate with internal cross-functional teams and external partners (CDMOs/CROs) to ensure scientifically robust analytical strategies and clear, compliant CMC documentation.

Key Responsibilities:

• Analytical Expertise: Provide scientific leadership in phase-appropriate external DS/DP analytical development/QC for NCE and NCE-like (e.g., Oligonucleotide) entities, including method development, validation, transfer, lifecycle management, and specifications.
• Stability & Quality Control: Contribute to DS/DP stability programs, assignment of retest periods/shelf lives, and independently review quality agreements, SOWs, study protocols, and batch data.
• Vendor Collaboration: Partner with internal teams and external vendors (CDMOs/CROs) to resolve technical challenges and quality events.
• CMC Technical Writing: Manage documentation workflow in the Veeva RIM system and author, review, and edit CTD Module 3 (Drug Substance and Drug Product) documents, specifically analytical sections.
• Regulatory Support: Contribute to the preparation of regulatory submissions, briefings, and responses to health authority inquiries.
  
  

Required Skills:

• Experience: Significant working experience (>6 years) in pharmaceutical/biotech CMC and analytical development of NCE and NCE-like drug substance and solid/liquid formulations.
• Regulatory Submissions: Demonstrated working experience with regulatory submissions and familiarity with GMP and global regulatory guidelines (ICH, FDA, EMA, USP, EP, etc.).
• Systems & Writing: Strong technical writing and organization skills, with specific experience writing/editing CTD Module 3 documents and working within the Veeva RIM system.
• Soft Skills: High attention to detail, scientific rigor, effective communication, stakeholder collaboration, and the ability to manage multiple priorities.
• Preferred Pluses: Direct experience with global regulatory submissions (IND, CTA, NDA, MAA) and working directly with external manufacturing or testing partners (CDMOs/CROs).