Director, CMC Technical Writing
The Director of Cell and Gene Therapy CMC Technical Writing plays a critical role in the development of our technical writing capabilities. In partnership with functional areas leads and regulatory leads, the Director is responsible for authoring the CMC sections of the AVROBIO’s global regulatory submissions from INDs, briefing books, license applications to post approval submissions. Core responsibilities include CMC technical writing, CMC source document and technical report writing, authorship of CMC sections of regulatory filings, facilitating a portfolio view across regulatory submissions, developing submission calendar and timelines.
In this role, the Director of CMC Technical Writing will partner closely with functional areas leads and regulatory leads to deliver high quality regulatory submission documents. The role ensures the technical documentation strategy & approaches evolve as needed based on learnings across the portfolio. Therefore, it is critical that the candidate effectively engages a matrixed team of internal and external partners to ensure organizational alignment