Analytical SME and CMC Technical Writer - Remote / Telecommute

We are looking for Analytical SME and CMC Technical Writer - Remote / Telecommute for our client in Ridgefield, CT

Job Title: Analytical SME and CMC Technical Writer - Remote / Telecommute

Job Location: Ridgefield, CT

Job Type: Contract

Job Overview:

Pay Range $50.72/hr - $55.72/hr

• 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).

Requirement/Must Have:

• Significant working experience (>6 years) in pharmaceutical/biotech CMC and analytical development of NCE and NCE-like drug substance and solid and liquid formulations.
• Demonstrated working experience in regulatory submissions.
• Familiarity with GMP and regulatory guidelines (e.g., ICH, FDA, EMA, USP, EP, etc.).

Responsibilities:

• Provide scientific leadership in phase-appropriate external DS/DP analytical development/QC for NCE and NCE-like entities, including method development, validation, transfer and lifecycle management.
• Contribute to the development of DS/DP phase appropriate specifications and analytical control strategies in collaboration with internal and external teams.
• Contribute to the development of DS/DP stability programs and assignment of DS retest period, DP shelf life and material holding times as needed, with internal and external teams to support FIH and following clinical trials.
• Independently propose or review quality agreement, SOW, study protocols/reports, batch/stability data, to support CMC deliverables in a timely fashion.
• Prepare and communicate clearly and independently technical plans, updates and deliverables as needed in the form of reports and/or presentations within the internal teams.
• Partner with internal teams and external vendors to resolve technical challenges and quality events and ensure timely, compliant deliverables.
• Support departmental submission activities by managing documentation workflow in Veeva RIM system.
• Demonstrated working experience in authoring, reviewing and editing CTD Module 3 (Drug Substance and Drug Product) documents, in particular analytical related documents.
• Contribute to preparation of regulatory submissions/briefings and responses to health authority inquiries.

Nice to Have:

• Experience in global regulatory submissions (IND, CTA, NDA, MAA).
• Experience working with external manufacturing or testing partners.

Skills:

• Strong organization and technical writing skills.
• High attention to detail and scientific rigor.
• Effective communication and stakeholder collaboration.
• Ability to manage multiple priorities in a fast-paced environment.

Qualification And Education:

• Advanced degree (e.g., PhD) is preferred, or Master's and Bachelor's degree in Analytical Chemistry, Pharmaceutical Sciences, or related discipline.