Hybrid Director Medical Writing & Regulatory Strategy

BioSpace; South San Francisco (CA); Hybrid; USD 223,000 - 271,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Mental health offerings

Equity incentive plan

401(k) with employer match

Generous holiday and PTO policy

Job summary

Maze Therapeutics is seeking a Director of Medical Writing to lead the regulatory writing function across late‑stage programs. You will oversee the preparation of clinical and regulatory documents, coordinate with Regulatory Affairs, Clinical Development, and external vendors, and ensure accuracy, consistency, and alignment with study objectives.

The role emphasizes scalable processes, structured content, and potential AI‑assisted tooling to improve efficiency while maintaining rigorous

Qualifications

• 8–10+ years regulatory medical writing experience.
• Advanced degree preferred; bachelor’s with relevant experience accepted.
• Experience with clinical/regulatory documents across development lifecycle.
• Strong regulatory knowledge: FDA/ICH/EMA guidance.
• Ability to interpret data and communicate clearly with sources.
• Experience managing external medical writing resources.
• Familiarity with structured content and automation tools.

Responsibilities

• Lead medical writing across Maze’s development programs.
• Manage medical writing vendors to ensure timely, high‑quality deliverables.
• Ensure documents reflect program strategy and data integrity.
• Collaborate with Regulatory Affairs and cross‑functional teams.
• Translate source materials into regulatory documents with alignment.
• Establish standards, templates, and review processes.
• Explore structured content and AI tooling to boost efficiency.

Skills

Regulatory medical writing expertise

Clinical/regulatory documents across L

Drug development regulatory knowledge

Interpret and communicate clinicalData

External medical writing management

Cross‑functional collaboration

Structured content / AI tools

Education

Advanced degree in scientific/medical field

Bachelor’s degree with significant relevant experience

Tools

AI‑enabled tools for medical writing

Job description

Maze Therapeutics is seeking a Director of Medical Writing to lead the regulatory writing function across late‑stage programs. You will oversee the preparation of clinical and regulatory documents, coordinate with Regulatory Affairs, Clinical Development, and external vendors, and ensure accuracy, consistency, and alignment with study objectives.

The role emphasizes scalable processes, structured content, and potential AI‑assisted tooling to improve efficiency while maintaining rigorous