Director, Medical Writing

GlobeNewswire

Director of Medical Writing specializing in high-quality clinical documents for regulatory submissions. Collaborating with cross-functional teams to deliver accurate and compliant documentation while ensuring strategic messaging.

Posted 7/2/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesLead💰 $190,000 - $235,000 per yearWebsite

About the role

Key responsibilities & impact

Lead the planning, authoring, review, and completion of clinical and regulatory documents required for submissions to the FDA and other global health authorities
Manage internal and external medical writing resources to deliver accurate, high-quality documents on time and in accordance with established standards
Author, edit, and collaborate with cross-functional team members on key documents, including protocols, investigator brochures, clinical study reports, CTD modules, briefing books, and related submission materials
Review and refine documents or document sections prepared by functional contributors to ensure quality, consistency, scientific accuracy, and adherence to company and regulatory standards
Contribute to project planning and cross-functional working groups to support efficient development, review, approval, and finalization of submission-ready documents
Establish and continuously improve medical writing processes, templates, and best practices to increase quality, consistency, and operational efficiency

Requirements

What you’ll need

Bachelor’s degree in life sciences or a related discipline required; advanced degree preferred, with a strong understanding of biochemistry and molecular biology principles
10+ years of medical writing experience in the pharmaceutical or biotechnology industry, with significant experience preparing clinical and regulatory documents
Deep experience authoring and reviewing clinical and regulatory documents
Ability to lead strategic discussions that align content and messaging across submissions,
Exceptional communication skills to influence cross-functional stakeholders.
Experience overseeing internal and external medical writing resources, including vendors, consultants, and cross-functional contributors
Demonstrated expertise writing, editing, and reviewing protocols, clinical study reports, investigator brochures, CTD modules, and other clinical regulatory documents
Strong understanding of FDA and international regulations, ICH guidelines, and regulatory processes related to document preparation, production, and submission, including CTD requirements
Experience developing and executing medical writing strategy across programs, submissions, or therapeutic areas
Proficiency with Microsoft Office, Adobe Acrobat, and shared document management systems such as SharePoint
Highly organized, with the ability to prioritize, manage multiple projects simultaneously, and deliver high-quality work under tight timelines
Detailed knowledge of requirements for key clinical, nonclinical, and regulatory documents supporting INDs, CTAs, annual reports, and related submissions
Strong attention to detail, accuracy, and consistency
Ability to synthesize, analyze, and present complex clinical and scientific data clearly and accurately
Self-directed, proactive, and effective at problem solving in a fast-paced, cross-functional environment
Strong collaboration skills, with the ability to integrate input from multiple contributors into clear, cohesive, submission-ready documents.

Benefits

Comp & perks

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Lead the planning, authoring, review, and completion of clinical and regulatory documents required for submissions to the FDA and other global health authorities
Manage internal and external medical writing resources to deliver accurate, high-quality documents on time and in accordance with established standards
Author, edit, and collaborate with cross-functional team members on key documents, including protocols, investigator brochures, clinical study reports, CTD modules, briefing books, and related submission materials
Review and refine documents or document sections prepared by functional contributors to ensure quality, consistency, scientific accuracy, and adherence to company and regulatory standards
Contribute to project planning and cross-functional working groups to support efficient development, review, approval, and finalization of submission-ready documents
Establish and continuously improve medical writing processes, templates, and best practices to increase quality, consistency, and operational efficiency 🎯 Requirements
Bachelor’s degree in life sciences or a related discipline required; advanced degree preferred, with a strong understanding of biochemistry and molecular biology principles
10+ years of medical writing experience in the pharmaceutical or biotechnology industry, with significant experience preparing clinical and regulatory documents
Deep experience authoring and reviewing clinical and regulatory documents
Ability to lead strategic discussions that align content and messaging across submissions,
Exceptional communication skills to influence cross-functional stakeholders.
Experience overseeing internal and external medical writing resources, including vendors, consultants, and cross-functional contributors
Demonstrated expertise writing, editing, and reviewing protocols, clinical study reports, investigator brochures, CTD modules, and other clinical regulatory documents
Strong understanding of FDA and international regulations, ICH guidelines, and regulatory processes related to document preparation, production, and submission, including CTD requirements
Experience developing and executing medical writing strategy across programs, submissions, or therapeutic areas
Proficiency with Microsoft Office, Adobe Acrobat, and shared document management systems such as SharePoint
Highly organized, with the ability to prioritize, manage multiple projects simultaneously, and deliver high-quality work under tight timelines
Detailed knowledge of requirements for key clinical, nonclinical, and regulatory documents supporting INDs, CTAs, annual reports, and related submissions
Strong attention to detail, accuracy, and consistency
Ability to synthesize, analyze, and present complex clinical and scientific data clearly and accurately
Self-directed, proactive, and effective at problem solving in a fast-paced, cross-functional environment
Strong collaboration skills, with the ability to integrate input from multiple contributors into clear, cohesive, submission-ready documents. 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 Medical Director 🔥 16 minutes ago Solventum 10,000+ employees ⚕️ Healthcare Insurance 📚 Education 🧘 Wellness Website LinkedIn All Job Openings Associate Medical Director at Solventum providing medical insights for product development and overseeing clinical studies. Collaborating with key teams to align objectives and ensure compliance. 🇺🇸 United States – Remote 💵 $143.2k - $196.9k / year ⏰ Full Time 🔴 Lead 👨‍⚕️ Medical Director Executive Medical Director 🔥 16 minutes ago BeOne Medicines 10,000+ employees Website LinkedIn All Job Openings Executive Medical Director overseeing clinical development strategies in hematology at BeOne. Collaborating with cross-functional teams to ensure best-in-class global capabilities. 🇺🇸 United States – Remote 💵 $329.7k - $409.7k / year ⏰ Full Time 🔴 Lead 👨‍⚕️ Medical Director Behavioral Health Medical Director 🔥 17 minutes ago Centene Corporation 10,000+ employees ⚕️ Healthcare Insurance 🤝 Non-profit 🌍 Social Impact Website LinkedIn All Job Openings Behavioral Health Medical Director managing medical management and quality improvement for 28 million members at Centene. Directs and coordinates medical leadership responsibilities while collaborating with various clinical teams. 🇺🇸 United States – Remote 💵 $236.5k - $449.3k / year ⏰ Full Time 🔴 Lead 👨‍⚕️ Medical Director Director, Medical Operations – Doctor of Medicine (MD) 🔥 17 minutes ago Natera 1001 - 5000 🧬 Biotechnology ⚕️ Healthcare Insurance 💊 Pharmaceuticals Website LinkedIn All Job Openings Director of Medical Operations overseeing physician experiences in oncology for Natera. Leading clinical initiatives and operational improvements for physician workflows and test utilization. 🇺🇸 United States – Remote 💵 $204k - $255k / year ⏰ Full Time 🔴 Lead 👨‍⚕️ Medical Director 🦅 H1B Visa Sponsor Director, Patient Financial Services – Healthcare CBO 🔥 26 minutes ago Guidehouse 10,000+ employees Website LinkedIn All Job Openings Director overseeing Hospital Client PFS department operations to manage patient accounting and billing processes. Ensuring compliance and optimizing revenue cycle indicators in healthcare services. 🇺🇸 United States – Remote 💵 $118k - $196k / year 💰 Grant on 2023-02 ⏰ Full Time 🔴 Lead 👨‍⚕️ 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 Find jobs using your resume 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 WritingClinical Study ReportsProtocolsInvestigator BrochuresCTD ModulesRegulatory SubmissionsBiochemistry PrinciplesMolecular Biology PrinciplesDocument ReviewEditing

Soft Skills

Exceptional CommunicationAttention to DetailProblem SolvingOrganizational SkillsCollaboration