Expert working knowledge of drug development, regulatory processes and guideline

Experience in a range of therapeutic areas, including Respiratory, Inflammation, Cardiovascular, Oncology and HIV

Delivery of a broad range of clinical-regulatory documents and information, operating at study, programme and strategy levels:

• Phase I, II and III CSRs
• Protocols
• IBs, IMPDs
• Narratives
• IND applications, IND annual reports
• Regulatory briefing documents (including pre-IND, Health Technology Assessment, MHRA, PMDA, FDA)
• Regulatory response documents for various global regulatory authorities
• CTD components, including Clinical Summaries and Clinical Overviews
• Ethics Committee submissions
• Informed consent documents and volunteer information

Strategic review and critique of clinical regulatory documents to improve quality and meet regulatory needs

Experience in clinical trial disclosure requirements (FDAAA) and processes

Proven ability to come into new projects and disease areas and quickly get up to speed

Delivery of training courses to project team members and external contractors on authoring and reviewing techniques

Mentoring and training junior medical writers