Director, CMC Technical Writing

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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

Feb 8 2021
Key Responsibilities
  • Develop business processes to create value added technical writing support in the near term while building capability for long term vision.
  • Support regulatory submissions from INDs, briefing books, license applications to post approval submissions
  • Develop timelines, templates and guidelines for regulatory and technical documents
  • Drive collaboration and efficient execution across technical functions on timely & high-quality delivery of technical documents for regulatory submissions
  • Work effectively with cross functional project teams and coordinate work within own function efficiently.
  • Remain current on GMP regulations, regulatory agency trends, and industry practices.
  • Facilitate timely and effective communication within and between functions and program matrix teams, including as member of appropriate matrix teams as needed.
Minimum Requirements/ Qualifications
  • BA/BS degree required; seeking balanced combination of technical and regulatory CMC experience.
  • 10 plus years direct professional experience in CMC development in biopharmaceuticals; strong understanding of cell and gene therapy drug development and regulatory approval process
  • Strong technical writing skills and prior experience with supporting regulatory filings across multiple jurisdictions,
  • Detail oriented, organized, with ability to influence others and a customer-focused mindset
  • Demonstrated ability to work through people; experience with matrix leadership and direct line management a plus.
  • Good understanding of biotech/cell & gene therapy regulations essential (ICH and other governing documents US and Global).
  • Comfort in agile environment; capable of bringing structure to vaguely defined problems while using creative yet pragmatic problem-solving approaches.
  • Highly effective written and verbal communication skills; strong presentation, facilitation, and stakeholder management skills.
  • Demonstrated experience in CMC development and implementation of business processes that enhance organizational sustainability.
  • Demonstrated ability to coach team leaders in navigating the complexities of a cross-functional, matrixed organization that is dynamic and rapidly evolving.
  • Inclusive interpersonal skills; ability to build relationships, influence, and drive organizational change.

AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.

AVROBIO, Inc is an EEO employer