Description
ICON is seeking a Principal Medical Writer to join their team. As a Principal Medical Writer at ICON, you will lead the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information.
Responsibilities:
- Develop regulatory documents for submission to regulatory agencies globally, including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews.
- Manage medical writing projects, including developing timelines and communicating with cross-functional team members.
- Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and processes.
- Review other documents associated with assigned projects, such as Protocols and Statistical Analysis Plans.
Requirements:
- A Bachelor's degree in a life science discipline, with a Master's degree in life science discipline preferred.
- At least 6 years of medical writing experience in the biopharmaceutical/CRO industry.
- Regulatory writing experience, including Clinical Study Reports, IBs, and 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.
- Strong communications, organisational, time management, and project management skills.
Rewards & Benefits:
- Competitive base salary and performance-related incentives.
- Health and wellbeing programmes, including medical, dental, and vision coverage.
- Retirement and pension plans.
- Life assurance and disability coverage.
- Employee assistance programmes and wellbeing resources.
- Learning and development opportunities through structured training and career pathways.