This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, Medical Writing based in United States.
This is an exciting opportunity for an experienced medical writing professional to lead the development of high-quality clinical and regulatory documentation supporting innovative therapeutic programs. In this role, you will collaborate closely with multidisciplinary teams to ensure scientific accuracy, regulatory compliance, and consistent messaging across development activities. You will play a strategic role in advancing regulatory submissions while driving process improvements and document quality standards. The position offers the chance to contribute to meaningful research in a collaborative, science-driven environment where precision, innovation, and cross-functional partnership are highly valued. Candidates who enjoy balancing technical expertise with project leadership will thrive in this role.
Accountabilities:
- Lead the preparation, authoring, editing, and review of a broad range of clinical and regulatory documents, including study protocols, investigator brochures, clinical study reports, CTD modules, briefing books, and submission materials.
- Collaborate with cross-functional stakeholders across clinical development, operations, pharmacology, research, biomarkers, medical affairs, and program management to ensure aligned, scientifically accurate, and regulatory-compliant documentation.
- Drive strategic document planning by ensuring consistent messaging across regulatory submissions and facilitating efficient document development throughout clinical programs.
- Manage document review cycles, coordinate comment resolution meetings, and ensure timely incorporation of stakeholder feedback while maintaining high quality standards.
- Contribute to project planning, regulatory submission readiness, and continuous improvement initiatives that enhance writing processes, templates, and document management practices.
- Ensure all deliverables comply with internal procedures, ICH/GCP guidelines, FDA and international regulatory requirements, and established quality standards.
Requirements
- Bachelor's degree in Life Sciences or a related discipline required; advanced degree preferred.
- Minimum of 5 years of medical writing experience within the pharmaceutical or biotechnology industry, with expertise in clinical and regulatory documentation.
- Proven experience authoring and reviewing protocols, clinical study reports, investigator brochures, CTD modules, and other regulatory documents.
- Strong understanding of FDA regulations, ICH guidelines, GCP standards, and global regulatory submission processes.
- Proficiency with Microsoft Office, Adobe Acrobat, and document management platforms such as SharePoint and Veeva.
- Excellent scientific writing, editing, communication, and project management skills, with the ability to manage multiple priorities under tight deadlines.
- Strong analytical thinking, attention to detail, and ability to synthesize complex scientific information into clear, compliant documentation.
- Demonstrated success collaborating across multidisciplinary teams while working independently with minimal supervision.
Benefits
- Competitive base salary ranging from $194,000 to $213,000 USD, based on experience, qualifications, and skills.
- Opportunity to contribute to innovative therapeutic development with meaningful patient impact.
- Collaborative, science-driven work environment with cross-functional exposure.
- Hybrid work flexibility.
- Professional growth opportunities within a rapidly advancing clinical development organization.
- Participation in projects spanning multiple clinical and regulatory programs.