Zentalis Pharmaceuticals
San Diego, CA
Provide strategic and operational medical writing expertise to prepare high-quality complex clinical and regulatory documents for health authority submissions.
Contribute to the medical and regulatory writing portfolio and collaborate across functional groups within the company.
Lead and maintain standardized document development processes for clinical and regulatory documents.
Develop and execute strategies for organizing and preparing documents for clinical and regulatory health authority submissions.
Independently author and/or lead the authoring and end-to-end development of clinical and regulatory documents.
Write, review, and edit science-based documents such as those included in IND/NDA sections.
Provide high-quality medical writing support to documents led by other company functional groups.
Manage contract medical writers, as needed, and review documents produced by external writers.
Collaborate with relevant company subject matter experts and document owners to develop...