# Principal Medical Writer

**Company**: ICON
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/UK-Swansea/Principal-Medical-Writer_JR150966?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_a06fa062-056

## 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.

## Skills

### Required
- medical writing
- regulatory submissions
- clinical development
- international regulations
- ICH guidelines

### Nice to have
- study designs
- analysis plans
- INDs
- marketing applications

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