Medical Regulatory Writer

1w1 week ago

Healx

Cambridge, GB · Full-time · £50,000 – £75,000

About this role

Healx pioneers next-generation drug discovery using frontier AI to accelerate rare disease treatments for 10,000 diseases affecting 400 million people, 95% without approved options. The Medical Regulatory Writer advances drug development by creating high-quality, accurate, compliant documentation for regulatory submissions. They translate complex scientific and clinical data into clear narratives for strategic decisions and patient impact.

Author clinical documents like protocols, amendments, briefing documents, IND annual reports, DSURs, Investigator’s Brochures, informed consent forms, and CSRs compliant with GCP and ICH guidelines. Collate, review, and interpret clinical data including adverse events, efficacy, and PK/PD. Lead document review workstreams, coordinating with project teams for timely, high-quality delivery.

Work as part of the Clinical Team with cross-functional groups including clinicians, scientists, and regulatory affairs professionals. Collaborate to evaluate data, develop study planning like SAPs and safety management plans, and contribute to clinical development strategies. Co-author company materials such as press releases, website content, and social media.

Support internal reviews for scientific journal submissions and shape publication strategy. Write abstracts, presentations, manuscripts, and grant applications to meet objectives. Enhance workflows by developing SOPs, document templates, and ensuring adherence to branding, regulatory requirements, and standards.

Requirements

Deep understanding of drug development process from early clinical trials to post-marketing surveillance
Proficiency in authoring clinical protocols, study reports, and regulatory documents
Knowledge of GCP, ICH, and other regulatory guidelines
Experience reviewing and interpreting clinical data on safety, efficacy, and PK/PD
Ability to lead cross-functional document review processes
Familiarity with clinical study planning including SAPs and safety management
Skills in scientific writing for publications, abstracts, and manuscripts
Understanding of regulatory submission requirements for INDs and DSURs

Responsibilities

Author clinical documents including protocols, amendments, and briefing documents
Prepare regulatory and clinical documents such as IND annual reports/DSURs, Investigator’s Brochures, informed consent forms, and CSRs compliant with GCP and ICH
Lead document review workstreams, coordinating with project teams for timely delivery
Collate, review, and interpret clinical data including adverse events, efficacy, and PK/PD
Support development of study planning including SAPs and safety management plans
Collaborate with project teams to evaluate clinical data and contribute to clinical development strategies
Co-author company materials including press releases, website content, and social media
Write abstracts, presentations, manuscripts, and grant applications to support objectives