Principal Medical Writer
Core
Lead strategy-driven authoring of key clinical and regulatory documents and submissions to ensure clarity, credibility, and consistency of clinical information for regulatory assessment and product labeling.
Role type
Principal Medical Writer (Regulatory & Clinical)
Builds
Regulatory submission packages (CSRs, CTDs, ODDs, PIPs) and prescribing information for rare disease therapies.
Domain
Biopharmaceuticals / Rare Diseases / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory medical writing expertise, clinical development knowledge, global regulatory environment understanding, project coordination, team leadership, strategic thinking, complex document authoring
Preferred skills
Experience with US and EMA submissions, coaching less experienced writers, managing cross-functional teams, handling multiple parallel tasks
Technologies
None explicitly stated
Responsibilities
Lead strategy-driven approach to authoring clinical components of regulatory submissions; prepare key clinical and regulatory documents; provide leadership and project coordination to cross-functional authoring teams; liaise with senior project staff to develop storyboards and plan document development; coach and develop less experienced Medical Writers; oversee and coordinate all Medical Writers including in-house consultants and CRO staff
Seniority
Principal, hands-on IC with strategic oversight
