Director, Medical & Regulatory Writing

Tr1X • San Diego, CA

2d • $200,000 - $220,000 • Onsite

About The Position

The Director, Medical and Regulatory Writing reports to the Vice President, Head of Regulatory Affairs and provides strategic planning, development, review, and delivery of high-quality medical, clinical, and regulatory documentation supporting Tr1X clinical programs. The role is responsible for establishing and executing medical writing strategies across clinical development programs, ensuring the timely preparation of scientifically accurate, regulatory-compliant documentation. The Director drives document quality and operational excellence and collaborates with senior leaders across Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Translational Medicine, CMC/Technical Operations, and other functions.
The position plays a critical role in supporting regulatory milestones and submissions throughout the product lifecycle, while ensuring alignment with applicable regulatory requirements, scientific standards, and corporate objectives.

Requirements

• Bachelor’s degree in a relevant scientific discipline, such as life sciences, biomedical sciences, or a related scientific field and a minimum 10 years of closely related experience.
• Experience working in pharmaceutical, biotechnology, or contract research organizations; experience in both sponsor and CRO environments is advantageous; experience on the sponsor side required.
• Proven expertise in advanced medical and regulatory writing.
• Extensive knowledge of clinical development processes, clinical trial methodologies, regulatory submission requirements, and regulatory authority expectations.
• Must have strong knowledge of ICH M11 and principles of the Common Protocol Template (CPT).
• Experience with preparing global protocols and ICFs for studies in multiple regions (e.g. US, EU, UK, Japan)
• A successful track record of delivering high-quality medical and regulatory documentation within defined timelines and quality standards.
• Knowledge of regulatory guidelines and standards.
• Detail-oriented with excellent scientific judgment and ability to apply critical thinking to document preparation and review.
• Strong interpersonal, organizational, project management, and verbal and written communication skills.
• Advanced computer skills in Microsoft Office 365 programs.
• Legally authorized to work for any employer in the U.S.

Nice To Haves

• An advanced degree in a relevant scientific discipline preferred.

Responsibilities

• Partner with Regulatory to develop and implement the medical writing strategy in alignment with corporate objectives, clinical development plans, regulatory strategies, and program goals.
• Author (writes & edits) high-quality documents across all program areas as needed such as clinical study protocols, protocol amendments, ICFs, clinical study reports, DSURs, Investigator’s Brochures, as well as more complex documents, e.g., INDs, NDAs, briefing packages, etc.
• Prepare and perform a quality review of clinical study protocols, protocol amendments, clinical study reports, investigator brochures, clinical summaries, and other essential clinical development documents.
• Lead, manage, and coordinate process for preparation of documents. This includes leading adjudication meetings to align on scope and to resolve comments, as well as driving timelines and interacting with Regulatory to coordinate final delivery for publishing.
• Ensure scientific conclusions are evidence-based, appropriately supported by clinical data, and consistent across the clinical and regulatory documentation portfolio.
• Establish standards for document consistency, reference verification, data presentation, medical terminology, and scientific interpretation.
• Advise leadership and cross-functional teams on document strategy, content risks, submission readiness, resource constraints, and critical timelines.
• Establish medical writing standards, processes, governance frameworks, templates, and quality-control procedures across development programs.
• Drive continuous improvement initiatives to enhance document quality, operational efficiency, consistency, timeliness, and compliance.
• Ensure compliance with applicable regulatory requirements and guidance, including ICH guidelines, Good Clinical Practice (GCP), and relevant FDA regulatory expectations.
• Oversee implementation of quality assurance processes for medical writing deliverables, including content review, document QC, traceability, and controlled document management.
• Partner with Quality Assurance and Regulatory Affairs to support inspections, audits, submission readiness assessments, and corrective and preventive actions when required.
• Partner with senior leaders and cross-functional team members in Clinical Development, Clinical Operations, Translational Medicine, CMC, and Quality.
• Resolve complex content disagreements and drive timely decisions across multidisciplinary teams.
• Evaluate appropriate technologies, automation, and artificial intelligence-enabled writing tools while maintaining scientific oversight, confidentiality, data integrity, and regulatory compliance.
• Perform other responsibilities based on business needs.

Benefits

• discretionary annual target bonus
• incentive stock options
• 401(k) retirement plan with company contribution
• health and welfare insurance plans for employees (and their families) that include medical, dental, vision, long-term and short-term disability, and life insurance
• paid time off (PTO)
• paid holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Director