Medical Writer - Sr H/F

Medical Writer - Sr H/F

Are you passionate about the world of Life Sciences and Clinical Research? Do you want to evolve in a dynamic and collaborative international environment where your expertise has a direct impact on the lives of millions of people?
Join Aixial Group and help shape the future of clinical research!
The Medical Writer is responsible for producing clear, precise, and regulatory compliant scientific and medical documents to support the laboratory's internal and external communication. He/she contributes to the valorization of medical and scientific data to healthcare professionals, health authorities, and the general public, where applicable.
If you recognize yourself in this brief summary, we invite you to learn more about the (non-exhaustive) missions that Aixial Group presents:
A. Writing Scientific and Regulatory Documents
Writing documents for clinical trials :
Clinical study protocols.
Investigator's Brochures.
Clinical study reports (CSR – Clinical Study Reports).
Information and consent forms for patients.
Preparing regulatory dossiers :
Marketing authorization dossiers (AMM) or submissions to authorities (ANSM, EMA, FDA).
Responses to health authority questions.
Adapting content according to the target audience (doctors, patients, regulators).
B. Medical and Scientific Communication
Creating communication materials :
Articles for medical journals or the general public.
Scientific presentations (slides for conferences, webinars).
Newsletters or digital content (websites, social media).
Collaborating with marketing teams

to ensure the scientific accuracy of promotional messages.
C. Scientific and Regulatory Watch
Conducting active surveillance

on therapeutic advances in the structure's expertise areas and regulatory developments.
Synthesizing and sharing

relevant information with internal teams.
D. Collaboration and Coordination
Working with multidisciplinary teams :
Doctors, biostatisticians, clinical project leaders, regulatory teams.
Participating in document review meetings .
Managing feedback and corrections

from reviewers (internal and external).
E. Standards and Quality
Applying standards

of good publication practices (GPP3, ICMJE) and transparency rules.
Ensuring traceability

of versions and modifications (document management tools).
Profile Sought
Education and Experience
Education:
Degree in health

(physician, pharmacist, doctorate) or

scientific training

(Master's in medical communication, DIU in medical writing).
Experience:
10 years of experience

in medical writing (laboratory, CRO, agency, institution).
Technical Skills:
Mastery of

medical writing standards

(GPP3, ICMJE, BPC).
Knowledge of

document management tools

(e.g., Veeva, SharePoint, TrackWise).
Ability to

interpret scientific data

(statistics, clinical results).
Language Skills:
Bilingual French

(mandatory) – clear and precise writing.
Scientific English from fluent to bilingual

(reading, writing, speaking – C1 minimum level).
Relational Skills:
Synthesis and pedagogy

to simplify complex concepts.
Diligence

and attention to detail (orthography, coherence, accuracy).
Ability to manage deadlines

and priorities.
Conditions and Benefits
Remote position in France (with potential travel 1 or more times per month).
The position is available immediately, with flexibility for candidates with notice periods.
Remuneration on a base of 58-65K.
Who Are We?
We are

one of the world leaders in CROs

(Contract Research Organizations) with a commitment, expertise, and flexibility necessary for conducting clinical studies.
We work with pharmaceutical, biotechnology, cosmetic companies, and more, providing innovative and adaptable solutions.
We

operate in 10 countries on 3 continents , bringing together more than

1000 talented professionals

who are committed to contributing actively to the advancement of clinical research.
We

are part of the ALTEN group since 2014

and continuously explore new opportunities to develop our business worldwide.
Joining Aixial Group means:
Being at the forefront of clinical research: You will work on cutting-edge projects where your expertise will be utilized and have a real impact on the lives of millions of people.
Continuously developing your career and skills: Our employees are at the heart of our concerns. At Aixial Group, you will be coached and mentored throughout your journey to help you progress both professionally and personally.
Working in an environment where equality, diversity, and inclusion are integral to our commitment: Our goal is to promote a work environment based on dignity and respect, where individual differences are recognized and valued, and where every employee can give their best. The issue of gender parity is at the heart of Aixial Group's development strategy.
Aixial Group continues to grow and recruit in the field of clinical studies, so come join us!