R320 Principal Medical Writer

PRA; Málaga; A distancia; EUR 60.000 - 100.000; Jornada completa

Descripción de la vacante

Join a leading clinical research organization as a Principal Medical Writer, where you will play a pivotal role in the development of regulatory documents for a Top-5 biotech company. This home-based position allows you to leverage your medical writing expertise in the challenging field of autoimmune diseases. You will be responsible for delivering high-quality clinical documents, guiding teams on best practices, and ensuring compliance with industry regulations. With a focus on career development and learning opportunities, this role offers a unique chance to make a significant impact in the healthcare sector while being a part of an inclusive and dynamic team.

Servicios

Comprehensive Benefits Package

Career Development Opportunities

Recognition Programs

Formación

• Minimum 6 years of experience in pharmaceutical/biotech medical writing.
• Strong knowledge of FDA and ICH guidelines for clinical reporting.

Responsabilidades

• Deliver all types of clinical, regulatory, and submission documents.
• Guide clinical teams on medical writing best practices.

Conocimientos

Medical Writing

Regulatory Documentation

Clinical Protocol Development

FDA Guidelines Knowledge

eCTD Submission

Communication Skills

Process Improvement

Educación

Master's Degree in Scientific Discipline

PhD in Relevant Field

Descripción del empleo

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

You will support a Top-5 biotech company, helping deliver best-in-class regulatory and submission documents. While employed by ICON, you will be fully embedded with our client, contributing your medical writing expertise to reduce time to market for their deep antibody pipeline.

The position is home-based, focusing on the challenging field of autoimmune diseases. Working with our client, you will benefit from ICON's learning opportunities and long-term career development.

What you will be doing: Medical Writing Excellence

1. Deliver all types of clinical, regulatory, and submission documents.
2. Draft and manage documents that are well-organized, accurate, consistent, and tailored to the target audience.
3. Develop key documents such as clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives, annual reports, eCTD modules, and other clinical/regulatory documents.
4. Lead in advising and guiding clinical teams on content and processes.
5. Ensure compliance with company SOPs and regulations.
6. Lead in a multi-stakeholder environment to ensure seamless delivery of regulatory documents.
7. Interact with clinical program leadership and teams to meet project deadlines.

Functional Leadership

1. Guide clinical teams on medical writing best practices.
2. Ensure documentation consistency using templates and style guides.
3. Disseminate industry and health authority regulatory guidelines.
4. Represent medical writing in internal meetings.
5. Recommend process improvements for high-quality regulatory document delivery.
6. Potentially represent the department in industry standards groups.
7. Support during audits of clinical trial documents, ensuring timely responses.

Who you are:

• Minimum 6 years of experience in pharmaceutical/biotech medical writing.
• Master's degree in a scientific, medical, or clinical discipline; PhD preferred.
• Knowledge of FDA and ICH guidelines for clinical reporting.
• Experience with eCTD development and submission preferred.
• Understanding of drug development processes from protocol to submission.
• Excellent communication skills and ability to collaborate across functions.
• Innovative mindset with proactive process improvement ideas.
• Ability to proofread for compliance and consistency.
• Experience in electronic publishing preferred.

We offer a comprehensive, competitive total rewards package, including base pay, variable pay, recognition programs, and employee benefits supporting you and your family throughout your career with ICON.

You will be a key medical writer at a Top-5 biotech company while being a full ICON employee.

ICON is an equal opportunity and inclusive employer.