Associate Director Medical Writing

Zentalis•San Diego, CA

2d•$180,000 - $220,000

About The Position

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 development processes for clinical and regulatory documents. The Associate Director will report to the Head of Medical Writing.

Requirements

Advanced degree in life sciences; PhD preferred.
At least 5-8 years of sponsor-level biotechnology or pharmaceutical clinical/regulatory medical writing experience required.
Extensive experience in oncology-focused medical writing, with significant exposure to regulatory submissions.
Recent direct or supportive NDA experience with clinical and regulatory documents, including authoring eCTD Module 2 clinical summaries (m2.7.2, m2.7.3, or m2.7.4) and/or overviews (m2.5), and Assessment Aid.
Significant experience with authoring protocols and amendments, Investigator Brochure annual updates, CSRs, and DSURs.
Must have strong analytical and critical thinking skills, strong attention to detail, ability to interpret and clearly present clinical data and other complex information, and an internal drive to produce clear and thorough, accurate, and high-quality documents.
Commitment to clearly understanding data and text, including proactively reaching out to medical writing senior management and/or subject matter experts to enable authoring clear and concise summary text that is understandable to reviewers from various backgrounds and experience.
Strong expertise in interpreting and synthesizing safety and efficacy data into meaningful insights and summaries.
Strategic thinker with a big-picture orientation.
Strong project management and leadership skills; ability to coordinate the efforts of team members according to timelines, and manage competing priorities.
Excellent written and verbal communication skills.
Exceptional partnership and collaboration skills. Able to prospectively identify potential problems and to partner effectively and positively to solve issues.
Understanding of scientific methodology as applied to drug development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission.
Knowledgeable in the regulatory guidance documents developed for documents authored by medical writing.
Ability to work independently, as well as collaboratively in a team.
Excellent time management skills and a proven ability to prioritize and work on multiple projects at any given time.
Working knowledge of AMA style, lean authoring, and regulatory document formatting conventions.
Expert in MS Office/Microsoft 365.

Nice To Haves

Experience with Veeva Vault preferred.

Responsibilities

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, including protocols and amendments, Investigator Brochure annual updates, CSRs, DSURs, eCTD modules for INDs and NDAs including clinical and nonclinical summaries and overviews, meeting requests, briefing books, and other documents required for oncology drug development.
Leverage scientific expertise to write, review, and edit science-based documents such as those included in IND/NDA sections, meeting requests, and briefing books.
Provide high-quality medical writing support to documents led by other company functional groups, including regulatory affairs, biostatistics, clinical operations, and clinical development.
Manage contract medical writers, as needed, including critically reviewing documents produced by external writers for scientific content and alignment with company position, clarity, accuracy, and consistency, with adherence to timelines and team expectations.
Work on multiple concurrent deliverables.
Collaborate with relevant company subject matter experts and document owners to develop content that is well-organized, consistent, accurate, and appropriate for clinical and regulatory reviewers.
Collaborate with cross-functional teams, including clinical development, clinical operations, regulatory affairs, pharmacovigilance, and biostatistics to ensure development of high-quality accurate documents delivered within project timelines.
Contribute towards the development of templates, SOPs, company style guide, and processes within medical writing to ensure quality and consistency of documents across programs.
Responsible for inspection-readiness of medical writing activities.
Collaborate with Regulatory Operations to support document formatting, publishing, and submission readiness.
Maintain up-to-date knowledge of global regulatory guidance and industry best practices.
Ensure final documents adhere to SOP, GCP, and ICH requirements