Principal Medical Writer

PRA; France; Sur place; EUR 50 000 - 80 000; Plein temps

Résumé du poste

A leading clinical research organization seeks a Principal Medical Writer to support a top biotech company. This home-office based role involves delivering key regulatory documents in the field of autoimmune diseases, with opportunities for career development and a competitive rewards package.

Prestations

Competitive total rewards package

Comprehensive benefits for you and your family

Inclusive and supportive workplace culture

Qualifications

• Minimum 6 years of pharmaceutical/biotech medical writing experience.
• Ability to interpret FDA and ICH guidelines.
• Experience with eCTD development and submission preferred.

Responsabilités

• Delivering clinical, regulatory, and submission documents.
• Advising clinical teams on content and process improvements.
• Ensuring compliance with SOPs and regulations.

Connaissances

Communication

Collaboration

Process Improvement

Proofreading

Formation

Master’s degree in a scientific, medical, or related field

PhD

Description du poste

As a Principal Medical Writer, you will join the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will support a Top-5 biotech company, helping deliver top-tier regulatory and submission documents. While employed by ICON, you will be fully embedded with our client, contributing to reducing time to market for their deep antibody pipeline.

This home-office based role involves working in the challenging field of autoimmune diseases. You will benefit from ICON’s opportunities for ongoing learning and long-term career development.

Responsibilities include:

1. Delivering clinical, regulatory, and submission documents.
2. Drafting and managing organized, accurate, and clear documents tailored to the target audience.
3. Developing key documents such as clinical protocols, ICFs, CSRs, IBs, patient narratives, annual reports, eCTD modules, and other clinical/regulatory documents.
4. Advising clinical teams on content and process improvements.
5. Ensuring compliance with SOPs and regulations.
6. Leading in a multi-stakeholder environment to ensure seamless document delivery.
7. Collaborating with clinical leadership to meet project deadlines.

Functional leadership duties include:

1. Guiding clinical teams on medical writing best practices.
2. Driving consistency in documentation using templates and style guides.
3. Disseminating industry and health authority guidelines.
4. Representing medical writing in internal meetings.
5. Proposing process improvements for quality and efficiency.
6. Potentially participating in industry standards working groups.
7. Representing medical writing during audits to ensure timely responses.

Candidate requirements:

1. Minimum 6 years of pharmaceutical/biotech medical writing experience.
2. Master’s degree in a scientific, medical, or related field; PhD preferred.
3. Ability to interpret FDA and ICH guidelines.
4. Experience with eCTD development and submission preferred.
5. Understanding of drug development phases and processes.
6. Strong communication and collaboration skills.
7. Innovative mindset with proactive process improvement ideas.
8. Proficiency in proofreading for compliance.

You will receive a competitive total rewards package, including base pay, variable pay, recognition programs, and comprehensive benefits supporting you and your family. As a key medical writer at a top biotech firm, you will be a full employee of ICON, benefiting from our inclusive and supportive workplace culture.

Why choose ICON?

We focus on developing our employees through continuous learning, engaging work, and professional growth. ICON is committed to diversity and inclusion, providing equal employment opportunities and reasonable accommodations for applicants with disabilities.

If you’re interested but unsure if you meet all requirements, we encourage you to apply — you might be exactly what we’re looking for.