Description
ICON is seeking a Senior or Principal Medical Writer to join their diverse and dynamic team. As a Medical Writer II, you will be responsible for leading the development of high-quality regulatory and clinical documents that effectively communicate scientific and medical information.
Responsibilities:
- Guides medical writing document preparation, including coordination of assignments to writers, review, and substantive editing of documents.
- Formulates writing approach, develops timelines, and assesses resource requirements for key documents and regulatory submissions.
- Participates on relevant project teams and task forces, and provides functional and cross-functional guidance on a wide range of issues related to document preparation.
- Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements.
- Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications.
- Provides review and substantive editing of contributions, and ensures resolution of issues.
- Within designated therapeutic or compound function, manages deliverables and preparation of documents for submission to regulatory agencies.
- Represents Medical Writing on cross-functional teams and task forces.
- Acts as a key Medical Point of contact for clinical regulatory strategy.
- As required, serves as lead writer for important regulatory response documents and key components of regulatory submissions.
- Provides leadership on functional teams that address requirements or issues related to document preparation and production.
Requirements:
- Bachelor’s degree in science, health profession required.
- At least 3 years of experience writing for pharma or biotechnology preferred.
- Experience with writing key documents like Clinical study reports, IBs, Protocols.
- Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment.
- Understanding of international regulations, ICH guidelines, and applicable international regulatory processes related to document preparation and production.
- Well-developed oral and written communication skills.
- Demonstrated problem-solving and interpersonal skills.
Benefits:
- Competitive base salary and performance related incentives.
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
- 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.