CMC Technical Writing Lead - Drug-Device & Regulatory

Avalyn Pharma Inc.; Boston (MA); On-site; USD 150,000 - 176,000; Full time

Job summary

Avalyn Pharma Inc. is seeking a Senior Manager, CMC Technical Writing to author, coordinate, and manage high‑quality scientific and regulatory documentation for CMC and product development programs.

You will collaborate with regulatory, QA, and external partners to ensure accuracy, traceability, and timely submission readiness. This hands‑on role requires translating complex CMC and drug‑device information into concise, defensible documents while managing multiple projects and timelines with

Qualifications

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Engineering, Biology, or a related scientific or technical discipline.
• 5–7+ years in pharma/biotech with CMC documentation experience.
• Ability to independently author complex CMC/technical reports.
• Experience with Design History File (DHF) documentation for drug-device products is a plus.
• Strong background in inhaled products or drug-device combination development is desirable.
• Excellent written and verbal communication with data integrity.
• Organizational skills to manage multiple document workflows and timelines.
• Proficiency with document templates, version control, and quality control.

Responsibilities

• Lead planning, authoring, and finalizing CMC development reports for drug substances, products, and devices.
• Prepare integrated reports covering formulation, analytical, aerosol characterization, device, and manufacturing aspects.
• Synthesize data and decisions into clear, defensible narratives for regulatory use.
• Drive documents through planning, cross-functional review, and approvals within program timelines.
• Create outlines, tables of contents, and data presentation plans for efficient drafting.

Skills

Scientific writing

Regulatory writing

Document coordination

Cross-functional collaboration

Attention to detail

Education

Bachelor's in Chemistry

Bachelor's in Pharmaceutical Sciences

Engineering or Biology degree

Tools

Microsoft Word

Job description

Avalyn Pharma Inc. is seeking a Senior Manager, CMC Technical Writing to author, coordinate, and manage high‑quality scientific and regulatory documentation for CMC and product development programs.

You will collaborate with regulatory, QA, and external partners to ensure accuracy, traceability, and timely submission readiness. This hands‑on role requires translating complex CMC and drug‑device information into concise, defensible documents while managing multiple projects and timelines with