Principal Medical Writer

.4 trillion by 2027, professionals with a strong background in medical writing are poised to drive innovation and growth. To succeed in this role, candidates will need to demonstrate a deep understanding of regulatory requirements, exceptional writing skills, and the ability to collaborate with cross-functional teams. Before applying, it's essential to research 4DMT's mission and values, as well as the current state of gene therapy development in the industry.

About the Role

The Principal Medical Writer will play a critical role in supporting the development of 4D-150, a gene therapy designed to transform the treatment of retinal vascular diseases. As a key member of the team, you will be responsible for planning, developing, and delivering high-quality clinical and regulatory documents, working closely with Clinical Science, Clinical Operations, Data Science, Regulatory Affairs, and external partners. Your expertise will be instrumental in driving the success of this innovative therapy, which has the potential to provide unprecedented benefits to patients.

As a Principal Medical Writer, you will be at the forefront of shaping the regulatory narrative for 4D-150, ensuring that all clinical documents are accurate, consistent, and compliant with regulatory requirements. You will collaborate with internal stakeholders and external vendors to develop and review key documents, including protocols, protocol amendments, clinical study reports, and briefing documents. Your ability to manage complex timelines, prioritize tasks, and maintain document version control will be essential to the success of this role.

The Principal Medical Writer will report to the Regulatory Affairs team and will work closely with other departments to ensure that all documents are aligned with the company's regulatory strategy. You will also have the opportunity to mentor and guide junior medical writers, sharing your expertise and contributing to the growth and development of the team.

What You Will Do

• Develop and deliver high-quality clinical and regulatory documents, including protocols, protocol amendments, clinical study reports, and briefing documents
• Collaborate with internal stakeholders and external vendors to develop and review key documents
• Manage complex timelines, prioritize tasks, and maintain document version control
• Ensure accuracy, consistency, and regulatory compliance of all clinical documents
• Develop and implement document planning and timeline management strategies
• Lead and coordinate external medical writers and vendors, including selection, scope definition, timeline management, content review, and quality oversight
• Serve as a key point of integration between internal subject matter experts and external writing resources
• Author, review, and coordinate key clinical and regulatory documents for the 4D-150 Phase 3 program
• Partner closely with Clinical Science, Biostatistics, and Clinical Operations to integrate data interpretations, safety narratives, and efficacy analyses
• Manage document review cycles, address comments, and ensure timely resolution of feedback from internal stakeholders and external vendors

What We Are Looking For

• Strong late clinical-stage medical writing experience, with a focus on regulatory documents and submissions
• Demonstrated ability to manage complex timelines, prioritize tasks, and maintain document version control
• Deep understanding of regulatory expectations for global Phase 3 programs and BLA readiness
• Excellent writing, editing, and communication skills
• Ability to collaborate with cross-functional teams, including Clinical Science, Regulatory Affairs, and Quality
• Experience with document planning and timeline management
• Strong knowledge of regulatory requirements, including ICH-GCP, FDA, and EMA guidelines
• Bachelor's degree in a scientific discipline, such as biology, chemistry, or pharmacology
• Advanced degree preferred, such as a Master's or Ph.D. in a relevant field

Nice to Have

• Experience with gene therapy development and regulatory submissions
• Knowledge of ophthalmology or retinal diseases
• Familiarity with clinical trial management systems and electronic data capture tools
• Certification in medical writing, such as the Board of Editors in the Life Sciences (BELS) or the American Medical Writers Association (AMWA)

Benefits and Perks

• Competitive salary and benefits package
• Opportunity to work on innovative gene therapy developments with the potential to transform patient care
• Collaborative and dynamic work environment
• Professional development and growth opportunities
• Flexible work arrangements, including remote work options
• Access to cutting-edge technologies and tools
• Recognition and reward for outstanding performance
• Comprehensive health insurance and retirement plans

• To stand out in this role, highlight your experience with regulatory documents and submissions, as well as your ability to manage complex timelines and collaborate with cross-functional teams.
• Be prepared to provide examples of your writing skills, including samples of clinical and regulatory documents you've developed in the past.
• Show a deep understanding of regulatory requirements, including ICH-GCP, FDA, and EMA guidelines, and be able to apply this knowledge to real-world scenarios.

-Demonstrate your ability to work independently and as part of a team, with strong communication and project management skills.

• Consider obtaining certification in medical writing, such as the Board of Editors in the Life Sciences (BELS) or the American Medical Writers Association (AMWA), to enhance your credentials and career prospects.
• Research 4DMT's mission and values, as well as the current state of gene therapy development in the industry, to show your passion and commitment to the field.