The Medical Writer is a pivotal role in the development of clinical trial-related documents and scientific publications.
Key Responsibilities:
* Authoring, reviewing, and editing clinical trial-related documents and regulatory documents
* Presenting clinical data objectively in a clear and concise format
* Ensuring timely delivery of these documents according to quality and/or regulatory standards
Main Responsibilities Include:
Clinical Document Development:
* Supports the development and writing of clinical and regulatory documents, including clinical study protocols and reports, investigator's brochures, informed consent forms, and diverse study plans
* Conducts literature reviews for medical devices as part of clinical evaluation reports
Data Analysis and Presentation:
* Analyses, appraises, and summarizes clinical data
* Writes literature review plans and reports according to regulatory requirements
Document Publication:
* Writes abstracts and publications according to journal formatting requirements
Collaboration and Communication:
* Collaborates with project managers to ensure efficient writing, editing, and publishing of clinical study documents and dossiers
* Keeps stakeholders informed on document progress and other project-related information
Required Skills and Qualifications:
* Master's degree in biological or (para-) medical sciences or equivalent by experience
* Certification as medical writer by acknowledged European or other professional organization
* Minimum 5 years' experience in clinical research or equivalent by education or relevant experience if PhD
* Minimum 2 years' experience with systematic literature research
Benefits:
* We offer a healthy work environment with a strong growth and international ambitions
* A flat organization structure with short communication lines
* An extensive training package and periodic knowledge-sharing moments
* Tremendous opportunities to continuously learn and expand your knowledge and skills
If you have what it takes to excel in this role, please submit your application with a CV and motivation letter in English.