Medical Writing Manager - US - Remote

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Requirements:

• Expert knowledge of medical writing principles and application
• Excellent written and spoken English, able to accurately interpret data and express findings in a clear and concise written manner
• Superior knowledge of applicable regulatory requirements and guidelines (in particular ICH E3, E6, and E9)
• University/college degree (life science or related allied health profession) and American Medical Writers Association Certification or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities.
• Minimum of 8 years of clinical pharmaceutical industry experience including medical writing
• 2+ years' experience managing a team of medical writers
• Thorough knowledge of applicable regulatory guidelines related to medical writing
• A demonstrated track record of success in medical writing and managing vendors
• Available for domestic and international travel, including overnight stays (valid passport)

Responsibilities:

• Manage the process and delivery of study documents such as protocols, informed consent documents, clinical study reports (CSRs), patient narratives, and other study documents
• Manage the process and delivery of product documents such as investigator drug brochures, summary documents, and other documents
• Manage direct reports (internal employees or vendors), as assigned
• Perform review and QC of documents, as needed
• Advise project team and clients on medical writing-related issues