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Senior Manager, CMC Technical Writing

Avalyn Pharma · Boston, MA · CMC and product development, reporting to the Senior Director of Product Development

Compensation

$150k – $176k /yr

Employment type

Full-time

Work setting

On-site

Location

Boston, MA

Schedule

Day shift

Posted

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Job overview

The Senior Manager, CMC Technical Writing role is onsite in Boston, MA. The proposed pay range is $150,000–$176,000 USD. The role supports Avalyn Pharma’s development programs for inhaled therapies targeting pulmonary fibrosis and other serious, rare respiratory diseases.

What you'll do

  • Plan, author, coordinate, review, revise, and finalize CMC technical reports and source documents
  • integrate formulation, analytical, aerosol characterization, device, manufacturing, and technology-transfer information
  • work with subject matter experts and external partners
  • manage document review and comment resolution
  • support CMC content for regulatory submissions and health authority interactions
  • maintain consistency and traceability across development and submission documents.

What we're looking for

Skills & competencies
cmc technical writing
senior manager
pharmaceutical development
regulatory writing
drug-device combination
technical reports
ind
impd
boston ma
avalyn pharma
pulmonary fibrosis
$150k–$176k
Work arrangement
  • Weekend coverage required

Why this role

The role supports drug-device combination products and regulatory deliverables, including INDs, IMPDs, CTAs, briefing packages, and regulatory responses.

About the employer

Avalyn Pharma is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.

Additional details

Industry sector
32
Industry
Pharmaceutical Preparation Manufacturing
Occupation code
27-3042.00
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