Biotrial, prestataire de service de l'industrie pharmaceutique, accompagne ses clients dans toutes les étapes du développement des médicaments et dispositifs médicaux depuis plus de 35 ans. Biotrial est leader en développement précoce, acteur incontournable dans les secteurs les plus scientifiques et innovants de la pharmacologie non clinique, des essais cliniques, de l'oncologie, de la bioanalyse et du traitement des données.
With over 35 years of expertise, Biotrial, a contract research organisation, helps to safeguard and improve the health of millions of people by advancing the treatment of diseases. By joining our company at one of our sites in Europe or the Americas, you will become part of a highly effective organisation and team. Teamwork and cross-departmental cooperation enable us to offer cutting-edge services. You will therefore be required to work closely with various departments.
As part of our expansion, we are currently seeking a Senior Medical Writer (M/F) for a permanent contract, based in Rennes.
Your role as Senior Medical Writer will enable you to apply your expertise in drafting deliverables related to clinical and non-clinical studies.
The role is open to candidates working 100% remotely.
Your main responsibilities in this role will include:
- Drafting documents in the following areas:
Clinical: Drafting clinical study protocols, clinical study reports (Phases I to IV), and other deliverables (such as DSURs, Investigator Brochures, CTDs) across various therapeutic areas (Phase I safety studies, oncology, neurology, cardiovascular, etc.)
Non-clinical: non-clinical reports
- Carrying out quality control of clinical study protocols, clinical study reports and other deliverables
- Writing scientific manuscripts and abstracts
- Preparing training materials
- Helping to develop and optimise our procedures and document templates
- Working closely with various departments (statistics, quality assurance, etc.)
- Taking part in commercial activities (responding to tenders, etc.)
The ideal candidate will have the following skills:
- A Master's degree, PhD or PharmD in Clinical Research, Regulatory Affairs or another scientific field
- At least 3 years' experience as a Medical Writer in a CRO or the pharmaceutical industry
- Excellent verbal and written communication skills in English
- Knowledge of regulatory requirements for medical writing
What you will bring to Biotrial:
- Your attention to detail and flexibility
- Your organisational skills and ability to work independently
- Your analytical mind
- Your ability to manage multiple projects simultaneously
What we offer:
- A small, family-run company based in Brittany with an international presence
- An induction programme is organised for new recruits, and there are excellent career opportunities within the company.
- Work location to be agreed based on your preferences: all our sites are accessible by public transport.
- Meal vouchers, profit-sharing scheme and attractive health insurance
- RTT/JNT
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