CMC Technical Writer III

The Fountain Group; Santa Monica (CA); Remote; USD 150,000 - 200,000; Full time

Job summary

A prominent Pharmaceutical company is seeking a CMC Technical Writer III to support critical CMC regulatory submissions. The role is remote and involves authoring module documents, responding to agency inquiries, and contributing to FDA filings. Ideal candidates will have late-phase CMC technical experience and a thorough knowledge of biologics analytical development. This position offers a rate of $75-$85/hr and is initially a 6-month contract.

Qualifications

• Experience with CMC regulatory submissions.
• Knowledge of biologics analytical and process development.
• Familiarity with FDA and EMA filings.

Responsibilities

• Author Module 3 documents and respond to agency questions.
• Support CMC regulatory filings and write change controls.
• Assist in FDA and BLA filings.

Skills

CMC Technical Writing

Regulatory submissions

Analytical methods

Job description

We are currently seeking a CMC Technical Writer III for a prominent Pharmaceutical client of ours. This position is Remote (PST Hours). Details for the position are as follows:

Job Description:

• Pay: 75.00-85.00/hr.
• Length of Assignment: 6 months to start with potential for extension or conversion.
• Seeking a highly motivated individual with late-phase CMC technical experience, including technical and regulatory submission experience.
• In the near-term, this role will support time critical CMC Regulatory submissions. Longer-term, this individual will be embedded in technical teams within the Process Development department supporting CMC aspects of our growing pipeline projects.
• Author and Finalize appropriate Module 3 documents and Response to Agency Questions in collaboration with Regulatory CMC and Technical Subject Matter Experts.
• Experience in analytical method development of vector and T cell, extended characterization of vector and T cell products, awareness of ICHs and global compendial requirements governing analytical development and characterization/comparability of Advanced Therapy Medicinal Products and vector intermediates is nice to have but not required.
• Thorough knowledge of biologics analytical and process development is essential. Cell therapy process development experience is nice to have but not required.
• Writing about analytical methods.
• Supporting CMC regulatory filings, writing change controls, writing deviations as they relate to quality activities.
• FDA and EMA Filings.
• BLA filing is the most critical.