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Senior Medical Writer (Lay Language)

Posted about 2 months ago

RemoteSaclay, Île-de-France, FranceSE

Redefine Medical. Empower Innovation. Build with Audacity.

Join Excelya as Our Next Medical Star!

At Excelya, we don’t just work—we Excelyate. Across 24 countries, 900+ passionate professionals are shaping the future of healthcare with one bold ambition: to become Europe's leading mid-size CRO, offering the best employee experience.

Now, we’re calling on curious minds and courageous spirits to step into a career-defining role in Medical Affairs. Ready to make an impact that travels the globe? Let’s talk.

Our Client Medical Writing department requires additional senior medical writing capacity to support the preparation of patient-facing documents written in lay language (plain language).

Your mission :

Focus on drafting patient-facing clinical documents in lay language :

  • Drafting and revising (as needed): Lay summaries of Clinical Study Reports (CSR lay summaries), Protocol synopsis in lay language (Plain Language Protocol Synopsis)
  • Coordination of : authoring activities, document planning, review cycles with stakeholders
  • Maintaining scientific accuracy
  • Meeting EU CTR / CTIS plain-language expectations
  • Coordinating multi-stakeholder reviews within timelines
  • Ensuring robust quality control and version management
  • Content planning and outline proposal
  • Drafting from : CSR / protocol, supporting materials
  • Incorporation of review comments
  • Version management
  • Final document preparation
  • Contribution to : terminology consistency, glossary, readability

Requirements

We are looking for a Senior Medical Writer with several years of clinical/regulatory writing experience

Degree in Life Science, Pharmacy, Medicine, or a related scientific field

Mandatory expertise: Lay-language writing, Health literacy principles, Patient-centric tone, Neutrality and accuracy,

Respect confidentiality, data protection, access controls

Experience with : EU CTR 536/2014, CTIS deliverables, Readability tools, Health literacy approaches

Langages : Autonomous writing in English

Benefits

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here's what makes us unique.

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience. Our one-stop provider service model offering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.

Job details
Workplace
Remote
Location
Saclay, Île-de-France, France
Experience
SE

Excelya is an independent, Paris-headquartered contract research organization (CRO) founded in 2014 that supports biotech, pharmaceutical, and medical device companies with full-service CRO, FSP, and resourcing solutions across clinical development. The company operates through a global network with 900+ experts and coverage in 25 countries, offering capabilities in areas such as clinical operations, data management, biometrics, pharmacovigilance, regulatory affairs, and medical affairs to help clients deliver clinical trials and bring new therapies to patients.

Industry
Pharmaceutical Manufacturing
Headquarters
Boulogne-Billancourt, Île-de-France
Founded
2014
Company location
Boulogne-Billancourt, Île-de-France
Specialties
Opérations cliniques, Affaires Réglementaires, Biométrie, Rédaction Médicale, Pharmacoviglance, Information Médicale, Contract Research Organisation, Biometrics and Clinical Research, Data Management, Pharmacovigilance, Medical Affairs, Biotech, Medical Devices, Clinical Trials, Drug Development Services, Oncology, Market Access, Rare Disease, Pharmaceuticals, CRO, Clinical Trial Optimization, Cell and Gene Therapy, Infectious Diseases, Immuno-Oncology, Cosmetics, and Nutrition

Key team members

Julien Sallaind

Julien Sallaind

Elitza Ouzounova

Elitza Ouzounova

Emilie Stefanelli

Emilie Stefanelli

Laurence MAUNIER

Laurence MAUNIER

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