Director of Medical Writing
Global Regulatory Writing & Consulting (GLOBAL)
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
About the role
- The Director of Medical Writing is a senior leadership role responsible for overseeing the strategic direction, management, and execution of medical writing activities across clinical, regulatory, and publication-related projects.
- Collaborate with key stakeholders, and drive process improvements, all while contributing to the success of the company’s clinical and regulatory goals.
- Oversee the preparation of all types of scientific and regulatory documents, including clinical study protocols, clinical study reports (CSRs), regulatory submissions (e.g., INDs, NDAs, BLAs), Investigator's Brochures, and other critical medical communications.
- Ensure that documents are scientifically accurate, clear, and compliant with regulatory guidelines, corporate style, and industry standards (e.g., ICH, GxP).
- Review and approve major documents to ensure alignment with overall scientific and regulatory strategy.
- Collaborate with clinical development, regulatory affairs, biostatistics, pharmacovigilance, and other internal stakeholders to ensure seamless development and delivery of high-quality medical writing documents.
- Ensure all medical writing deliverables comply with regulatory guidelines, ethical standards, and industry best practices.
- Continuously assess and optimize the medical writing process to improve efficiency, reduce errors, and enhance document quality.
Requirements
- Advanced degree (PhD, MD, PharmD, MS, or equivalent) in a scientific discipline (e.g., life sciences, pharmacology, medical sciences) required.
- Minimum of 8-10 years of medical writing experience in the pharmaceutical, biotechnology, or healthcare industry, with at least 5 years in a leadership or senior management role.
- Proven experience in overseeing complex regulatory submissions, clinical study documentation, and scientific publications.
- In-depth knowledge of global regulatory requirements, ICH guidelines, GxP, and medical writing standards.
- Strong leadership and team management skills, with a demonstrated ability to build and mentor high-performing teams.
- Excellent written and verbal communication skills, with the ability to convey complex scientific and regulatory information in a clear, concise, and accessible manner.
- Strong project management skills with experience managing multiple projects, timelines, and resources.
- Advanced knowledge of medical writing tools (e.g., Microsoft Word, EndNote, Reference Manager, Adobe Acrobat) and regulatory submission platforms.
Benefits
- Budget & Resource Management: Manage the department’s budget, including allocating resources appropriately for ongoing projects and initiatives.
- Health insurance
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical writingregulatory submissionsclinical study documentationscientific publicationsglobal regulatory requirementsICH guidelinesGxPmedical writing standardsproject management
Soft Skills
leadershipteam managementcommunicationprocess improvement
Certifications
PhDMDPharmDMS