Key skills
Statistical AnalysisProject ManagementCommunicationTime Management
About this role
Role Overview
- Develop regulatory documents for submission to regulatory agencies globally, including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, in accordance with ICH and other global guidelines, standards and processes.
- Manage medical writing projects, including developing timelines and communication with cross-functional team members to maintain awareness of review cycles and expectations.
- Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any processes needed for the completion of regulatory documents.
- Review other documents associated with the assigned project(s) (e.g., Protocols and Statistical Analysis Plans), as appropriate.
Requirements
- A Bachelor's degree in a life science discipline, with Master's degree in life science discipline preferred.
- At least 6 years of medical writing experience in the biopharmaceutical/CRO industry required.
- Regulatory writing experience
- Clinical Study Reports, IBs, Protocols
- Experienced writer who has ideally led submissions in addition to other document experience
- Oncology experience would be a plus
- Proficient understanding and knowledge of domestic and international regulatory requirements required and knowledge of therapeutic areas in all phases of clinical development desired.
- Proficiency in organizing and communicating clinical information necessary.
- Strong communications, organizational, time management, and project management skills are required.
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.