You are a highly skilled professional with passion for the world of life sciences and clinical research? You want to thrive in a dynamic and collaborative international environment where your expertise directly impacts people lives?

Come and join Aixial Group to contribute to shaping the future of clinical research!

We are currently seeking a Medical Writer (M/F) whose main responsibilities will include (non-exhaustive list) :

Key responsibilities :

• Gather information from technical contacts (medical writers, physicians, statisticians, regulatory affairs, and pharmacovigilance team members).
• Create and update abbreviated protocols, amended protocols and lay protocol synopsis.
• Co-write and write clinical study reports for phase 1 to 4 studies.
• Draft various clinical documents required for regulatory submissions and study management.
• Oversee the operational aspects of Clinical Research Organization (CRO) activities related to document preparation.
• Serve as the medical writer in charge of P70/PRCI and EU CTR coordination tasks.
• Contribute to the creation of Q&A documents, briefing books and benefit-risk assessments.
• Contribute to the production of operational plans (Data Management plan, Statistical Analysis Plan, Statistical Validation Plan).
• Evaluate and recommend standards and processes related to medical writing.

Profile and skills required :

• Holder of a BAC+5, PharmD, or PhD (scientific, biomedical, or equivalent),
• Minimum of 5 years of experience as a Medical Writer.
• Excellent interpersonal skills with the ability to collaborate effectively with different teams.
• Strong organizational and analytical skills.
• Fluency in English is required.
• Proficiency in French is a plus.
• Remote position.

Who Are we?

• We are one of the world’s leaders in CRO (Contract Research Organisation) with the commitment, expertise, and flexibility needed to deliver efficient clinical trials.
• We work with global pharmaceutical, biotech, cosmetic, medical device, and many other companies around the globe, providing them with innovative and scalable solutions.
• We are operating in 10 countries across 3 continents, bringing together over 1000 talented professionals dedicated to make a positive impact in the life sciences industry.
• We have been part of ALTEN Group since 2014 and are continuously exploring new opportunities to expand our activity worldwide.

Why Join Us?

• Make a positive impact and be at the forefront of project: 

You will be part of groundbreaking advancement in clinical research that has positive impacts on millions of people’s lives globally.

• Career Development:

People are our biggest asset. We are committed to empower our team continually and build a positive and supportive environment that fosters growth, flexibility, and teamwork. At Aixial Group, you will be coached and mentored throughout your journey to help you advance your professional and personal growth.

• Our commitment to Diversity, Equality, and Inclusion:

We aim to create a workforce which promotes dignity and respect, where individual differences are recognized and valued, and where each employee can give their best.

Gender equality is at the core of the development strategy of Aixial Group.

Aixial Group continues to grow, and to recruit in the clinical trial professions. Join us, and discover our website to follow the news of our offers: https://www.aixialgroup.com/join-us/

For more information: https://www.linkedin.com/company/aixialgroup/about/