Zentalis Pharmaceuticals

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...

Zentalis Pharmaceuticals San Diego, CA
Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its investigational first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemotherapy, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care. POSITION SUMMARY The Associate Director, Medical Writing will provide strategic and operational medical writing expertise to prepare high-quality complex clinical and regulatory documents for health authority submissions. This position will contribute to the medical and regulatory writing portfolio and will collaborate across functional groups within the company to lead and maintain standardized document...