Orca is hiring a
CMC Technical Writing Consultant

Summary

The CMC Technical Writer will be responsible for authoring and reviewing technical reports, managing CMC sections of various regulatory submissions, and working closely with cross-functional teams. This is a full-time position with the potential to work on BLA filings.

Requirements

• Minimum of Bachelor's degree in Chemical, and/or, Biological Sciences/relevant discipline
• 3+ years' experience in technical writing for CMC regulatory filings in cell therapies
• Strong working knowledge of full CMC spectrum, including drug substance and drug product manufacturing, stability requirements, analytical and formulation development and GMP manufacturing considerations in general
• Knowledge of FDA, EMA and global regulations including ICH guidelines with a strong knowledge of eCTD elements and structure
• Demonstrated ability to translate technical information from mixed sources into written information suitable for regulatory authorities
• Excellent verbal/written communication skills; detail/accuracy oriented
• Proven planning and organizational skills and regulatory writing skills
• Ability to work independently in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing demands

Responsibilities

• Author and/or review technical reports as required by CMC staff
• Author, compile, and manage CMC sections of a wide variety of regulatory submissions including, but not limited to, CMC Amendments to FDA filings, briefing book meeting packages and BLA submissions (module 3)
• Effectively manage the integrated drafting and reviewing process to meet appropriate timelines
• Ensure that technical reports adhere to appropriate regulatory guidelines
• Work closely with cross-functional teams to gather input and feedback for report content and formatting
• Organize and maintain document storage to ensure easy access to reports and related documentation

Preferred Qualifications

• M.S. or Ph.D. in Chemical, and/or, Biological Sciences/relevant discipline
• Experience working in a CMC role with cell-based therapies
• Prior BLA filing experience