• Writes clear and concise clinical submission documents, including clinical study reports, protocols, clinical overviews, investigator brochures, and summary documents; experience with late-stage health authority responses is a plus.

• Contributes to project plan concerning timelines as well as organization and table layout for a specific document.

• Ensures that documents meet regulations, and the key messages as defined by the team are clearly and adequately represented.

• Review and edit documents for consistency, progression, structure, and grammar.

• Review statistical analysis plans and incorporate into clinical study reports

or submission documents, as applicable.

• Drive the document preparation process, manage timelines, receive, and review primary statistical output, draft, and distribute document for review, compile comments and edits, lead comment resolution meetings independently.

• Participate in team and client meetings as requested

• Deliverables above plus able to work independently on a range of complex clinical documents

• Interprets, summarizes, and presents statistical and medical information to ensure accuracy of content in highly complex document types independently

• Resolves complex problems independently

• At least 8(PhD)-10(Masters) years of regulatory medical writing experience in the pharmaceutical industry.

•Extensive medical writing experience inclusive of clinical study documents and global clinical regulatory submissions.

• Extensive authoring experience across multiple TAs in both early and late development programs.

• Experience authoring Health Authority responses is required.

• Strong project management skills required.

• Ability to understand and interpret clinical and scientific data; ability to present results in an understandable manner to a variety of audiences.

• Knowledge of current requirements and guidelines applicable to submission documents.

• Excellent writing skills.

• Excellent interpersonal and oral communication skills.

• Strong knowledge of MS Word and Outlook, some knowledge of Excel and PowerPoint.

• Project management and organizational skills required including ability to manage timelines and prioritize multiple projects.