Manager, Medical Writing
ICON Strategic Solutions · United States · 1 wk ago
RemoteRemotePublic RelationsFull-time
About the role
As a Manager, Medical Writing at ICON, you will lead a team of medical writers to produce high-quality, scientifically accurate documents in support of clinical trials. Your focus will be on coordinating medical writing delivery, resolving issues, and developing team capability.
Responsibilities
- 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.
- 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.