Senior Medical Writer

Senior Medical Writer (UK/EUROPE) - CRO

SUMMARY: The Senior Medical Writer is responsible for carrying out medical writing activities in accordance with client specifications in a timely, accurate, and efficient manner, within budget, and to the written, scientific, and ethical standards in accordance with regulatory requirements and standard operating procedures (SOPs).

RESPONSIBILITIES:

• Prepare study documents such as protocols, informed consent documents, clinical study reports (CSRs), patient narratives, and other documents in accordance with regulatory requirements and SOPs.
• Prepare product documents such as investigator drug brochures, summary documents, and others in accordance with regulatory requirements and SOPs.
• Coordinate internal and client document review cycles.
• Attend project-related meetings, as needed.
• Perform review and QC of documents, as needed.
• Serve as publishing point-of-contact in conjunction with the document coordinator to publish CSRs or other documents, as needed.
• Create and manage project-specific timelines, an adaptation of timing, and milestones based on client needs/feedback.
• Identify and appropriately communicate risks associated with document delivery and propose mitigation plans.
• Advise project team and clients on medical writing-related issues.
• Complete project-specific and company training, as assigned.

REQUIREMENTS:

• University/college degree (life science or related allied health profession)
• Graduate degree preferred. • Minimum of 3 years of clinical pharmaceutical industry experience including skills and competency in medical writing.
• Available for domestic and international travel, including overnight stays (valid passport)