Analytical SME & CMC Technical Writer (Remote) | Pharmaceutical Development & Regulatory Submissions

Location: Remote (U.S.)
Duration: 12-Month Contract
Job ID: 37278373
Client: Leading Global Pharmaceutical Company
Employment Type: Contract

Analytical SME & CMC Technical Writer – Remote Opportunity

Sigma Systems is seeking an experienced Analytical Subject Matter Expert (SME) & CMC Technical Writer to support external Drug Substance (DS) and Drug Product (DP) development programs within a global pharmaceutical environment.

This is an excellent opportunity for a pharmaceutical or biotech professional with expertise in analytical development, quality control, regulatory submissions, and CMC technical writing. The successful candidate will collaborate with cross-functional teams and external partners to support analytical strategies, technical documentation, and global regulatory filings.

Key Responsibilities

Analytical Development & CMC Support

• Provide scientific leadership for Drug Substance (DS) and Drug Product (DP) analytical development and quality control activities.
• Support analytical method development, validation, transfer, and lifecycle management.
• Develop and review phase-appropriate analytical control strategies and specifications.
• Contribute to stability programs, retest period assignments, shelf-life determinations, and material holding time evaluations.
• Review and provide input on quality agreements, statements of work (SOWs), study protocols, technical reports, and analytical data packages.
• Analyze batch and stability data to support regulatory and development milestones.
• Partner with CDMOs, CROs, and internal stakeholders to address analytical and quality-related challenges.
• Prepare technical presentations, reports, and project updates for cross-functional teams.

CMC Technical Writing & Regulatory Submissions

• Author, review, and edit CMC documentation for global regulatory submissions.
• Support preparation and maintenance of CTD Module 3 documentation for Drug Substance and Drug Product.
• Manage submission documentation workflows within Veeva RIM.
• Contribute to IND, CTA, NDA, and MAA submissions and responses to regulatory authorities.
• Ensure documentation complies with FDA, EMA, ICH, USP, EP, GMP, and other global regulatory requirements.
• Maintain consistency, scientific accuracy, and compliance across regulatory submission documents.

Required Qualifications

• Bachelor's, Master's, or PhD in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related scientific discipline.
• Minimum 6+ years of pharmaceutical or biotechnology industry experience in CMC, analytical development, or quality control.
• Experience supporting New Chemical Entity (NCE) and NCE-like development programs.
• Demonstrated experience with analytical method development, validation, transfer, and lifecycle management.
• Experience authoring, reviewing, and editing CTD Module 3 documentation.
• Working knowledge of Veeva RIM document management systems.
• Experience supporting regulatory submissions and health authority interactions.
• Strong technical writing, communication, and organizational skills.
• Ability to manage multiple projects and deadlines in a fast-paced environment.

Preferred Qualifications

• PhD preferred.
• Experience supporting IND, CTA, NDA, and MAA submissions.
• Experience with oligonucleotide, biologic, or small molecule development programs.
• Experience working with CDMOs, CROs, and external manufacturing/testing partners.
• Strong knowledge of GMP regulations and global regulatory requirements.
• Familiarity with FDA, EMA, ICH, USP, and EP guidelines.