Leads/supports development (including authoring, editing, coordinating reviews, QC, finalization) of clinical and regulatory documents (e.g., protocols, amendments, investigator brochures, clinical study reports, eCTD clinical summaries, briefing books, IRs)
Drives cross-functional collaboration in the preparation of clinical and regulatory documents, including alignment on content and messaging, effective conduct of roundtable meetings, resolution of feedback/comments
Distills large amounts of clinical and scientific data into clear, consistent messaging that aligns with program strategy
Adheres to departmental procedures and practices and applies ICH/GCP/regulatory guidelines and industry standards to document development
Contributes to developing/implementing processes and best practices within the Clinical and Regulatory Writing department
Represents Clinical and Regulatory Writing department on various cross-functional teams

BS or MS in a scientific or medical field
5+ years of relevant medical writing experience in the biotechnology/pharmaceutical industry
Demonstrated experience in development of clinical and regulatory documents; least one eCTD submission strongly preferred
Ability to interpret and create complex tabular and graphical clinical data presentations
Exceptional oral and written communication skills
Capable of working on multiple tasks and shifting priorities
Demonstrated flexibility and adaptability to changing strategy and timelines
Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive organizational goals
Demonstrated proficiency and experience with Microsoft Office Suite and Veeva Vault; StartingPoint template, EndNote, Smartsheet, AI tools is a plus
Knowledge of drug development stages, clinical research concepts, regulatory and ICH guidelines as applicable to document writing
Rare disease experience is a plus

Senior Manager, Medical Writing

Key skills