Description
We are currently seeking a Senior or Principal Medical Writer to join our diverse and dynamic team. As a Principal Medical Writer, 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.
- 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.
- Represents Medical Writing on cross-functional teams and task forces.
Requirements:
- Bachelor’s degree in science, health profession required.
- At least 5 years of experience writing for pharma or biotechnology preferred.
- Experience with writing key documents included in major international regulatory submissions required.
- Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment.
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.