# 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/Germany-Frankfurt/Principal-Medical-Writer_JR150969?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_7a572acc-1ed

## 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.

## Skills

### Required
- medical writing
- regulatory documents
- clinical study reports
- project management

### Nice to have
- oncology experience

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Source: [Apply at icon.wd3.myworkdayjobs.com](https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/Germany-Frankfurt/Principal-Medical-Writer_JR150969?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)