Expert Regulatory Writer

1w1 week ago

Novartis

London, GB · Full-time · £80,000 – £110,000

About this role

As an Expert Regulatory Writer in the Regulatory Writing and Submissions team, you will author, review, and manage high-quality clinical documentation for regulatory submissions supporting clinical trials and marketing applications. You will serve as a subject matter expert, providing authoritative consultancy on documentation-related matters to other departments. This role reports directly to the Unit Head.

You will independently handle complex documents like Clinical Trial Protocols, amendments, Clinical Study Reports, and CTD submission documents including clinical overviews and summaries. Lead writing teams for complex submissions, contribute to key messaging, and ensure compliance with internal standards and external requirements. Provide expert guidance on clinical content.

Act as a member of Clinical Trial Teams, leading Protocol and CSR sub-teams, and serve on Clinical Submission Teams and Global Clinical Teams. Facilitate cross-functional communication for effective feedback on documentation. Serve as Program Writer for large programs, liaising with clinical teams for resource consistency.

Coach and mentor junior writers while leading RWS process improvements cross-functionally. Provide input into data analyses planning for CSRs and submissions. Maintain compliance with audit requirements, SOPs, and training standards in a matrixed environment.

Requirements

Academic degree in life sciences, healthcare, or a related field; advanced degree preferred
Full professional proficiency in English (native or near-native level)
Several years of experience in medical writing or relevant pharmaceutical industry roles with strong scientific and regulatory knowledge
In-depth understanding of global regulatory environment, Health Authorities, clinical trial design, and documentation requirements
Proven experience and success in global drug registration
Strong knowledge of biostatistics principles
Excellent communication skills and experience in matrixed organizational environment
Demonstrated ability to prioritize multiple projects and solve complex problems

Responsibilities

Independently author, review, and manage high-quality clinical documents including Clinical Trial Protocols, Clinical Study Reports, and CTD submission documents
Lead writing teams for complex submissions, contributing to key messaging and ensuring compliance with standards and requirements
Act as member of Clinical Trial Teams, leading Protocol and CSR sub-teams, and core member of Clinical Submission Teams
Provide input into planning and presentation of data analyses for CSRs, submission documents, and regulatory responses
Ensure documentation compliance with internal standards and external guidelines for CTP and CTD clinical sections
Serve as Program Writer for large and complex programs, liaising with clinical teams for consistency
Lead and contribute to RWS practices and process improvements cross-functionally
Coach and mentor junior writers and facilitate cross-functional communication