Associate Director, Medical Writing

Zentalis Pharmaceuticals

Associate Director of Medical Writing for oncology at Zentalis. Preparing regulatory documents and collaborating with cross-functional teams in a remote or hybrid setup.

Posted 6/29/2026full-timeSan Diego • California • 🇺🇸 United StatesSenior💰 $180,000 - $220,000 per yearWebsite

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

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 content.
Collaborate with cross-functional teams to ensure development of high-quality accurate documents delivered on time.
Contribute to the development of templates, SOPs, and company style guide to ensure quality and consistency of documents across programs.
Responsible for inspection-readiness of medical writing activities.
Maintain up-to-date knowledge of global regulatory guidance and industry best practices.

Requirements

What you’ll need

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.
Experience with Veeva Vault preferred.

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Zentalis Pharmaceuticals Website LinkedIn All Job Openings 51 - 200 employees 💰 $25M Post-IPO Equity on 2022-04 Developing potentially best-in-class, novel small molecules targeting fundamental biological pathways in cancer Associate Director, Medical Writing 🔥 56 minutes ago 🏢🏡 San Diego – Hybrid 💵 $180k - $220k / year ⏰ Full Time 🟠 Senior 👨‍⚕️ Medical Director Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
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 content.
Collaborate with cross-functional teams to ensure development of high-quality accurate documents delivered on time.
Contribute to the development of templates, SOPs, and company style guide to ensure quality and consistency of documents across programs.
Responsible for inspection-readiness of medical writing activities.
Maintain up-to-date knowledge of global regulatory guidance and industry best practices. 🎯 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.
Experience with Veeva Vault preferred. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Associate Director, Clinical Pharmacology 🕒 2 days ago Pfizer 10,000+ employees Website LinkedIn All Job Openings Clinical Pharmacology Lead providing expertise for oncology clinical development programs. Collaborating with multidisciplinary teams to optimize drug development using quantitative approaches. 🏢🏡 San Diego – Hybrid 💵 $139.1k - $231.9k / year 💰 Post-IPO Debt on 2023-05 ⏰ Full Time 🟠 Senior 👨‍⚕️ Medical Director 🦅 H1B Visa Sponsor View More Medical Director Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

Medical WritingRegulatory SubmissionsECTD Module AuthoringProtocol AuthoringClinical Data InterpretationDocument Development ProcessesSOP DevelopmentSafety And Efficacy Data SynthesisTime ManagementScientific Methodology

Soft Skills

Analytical SkillsAttention To DetailCommunication SkillsCollaboration SkillsProblem-Solving Skills