Manager, Medical Writing

Role Overview

• Lead a team of medical writers to produce high-quality, scientifically accurate documents in support of clinical trials.
• Manage the medical writing team, providing guidance and oversight to ensure high-quality, consistent, and scientifically sound documentation.
• Oversee the preparation of clinical study reports, regulatory submissions, protocols, investigator brochures, and other key clinical documents.
• Collaborate closely with cross-functional teams including clinical, regulatory, and project management teams to ensure alignment and accuracy in documentation.
• Ensure that all documents comply with applicable regulatory guidelines and internal standards while maintaining clear and concise scientific communication.
• Track project timelines and deliverables, ensuring that all documentation is completed and submitted within established deadlines.
• Continuously improve writing processes and templates, incorporating best practices to enhance the efficiency and quality of the medical writing function.

Requirements

• Bachelor's degree in life sciences, health sciences, or a related field is preferred, with extensive experience in medical writing within the pharmaceutical or clinical research industry.
• Proven experience in managing medical writing teams and overseeing the development of regulatory and clinical documents.
• Strong knowledge of regulatory requirements, clinical trial processes, and scientific writing best practices.
• Excellent writing, editing, and communication skills, with the ability to convey complex scientific concepts clearly and accurately.
• Strong organizational and leadership abilities, with experience in managing multiple projects and ensuring on-time delivery.
• Detail-oriented, adaptable, and proactive, with a commitment to maintaining the highest standards in medical writing.

Benefits

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.