Director, Clinical and Technical Writing

Role Overview:

• Directs clinical and technical writing to support development of high-quality documentation across Clinical, Regulatory, Technical, and Medical Affairs functions.
• Provides strategic insight and scientific rigor to ensure timely and compliant delivery of key documents supporting the innovative pipeline.

Responsibilities:

• Deliver high-impact scientific documentation including protocols, study reports, investigator brochures, and regulatory submission sections.
• Champion quality and compliance by ensuring documents meet internal standards and global regulatory requirements such as ICH, GCP, FDA, and EMA.
• Partner across functions including Clinical, Regulatory, Biostatistics, CMC, Safety, and Medical Affairs teams for seamless document development.

Qualifications:

• Requires a Bachelor’s degree in Life Sciences with an advanced degree preferred and 12+ years of medical writing experience in the pharmaceutical or biotech industry.
• Must have demonstrated expertise authoring and managing clinical and regulatory documents with strong knowledge of FDA/EMA regulations and ICH guidelines.
• Needs exceptional written and verbal communication skills with proven ability to manage multiple projects simultaneously in a fast-paced environment.