Medical Writer/Editor (m/f)

Description

• Edit other writers' work, check for scientific accuracy and grammatical or editorial errors
• Propose continuous improvements of the procedures and work instructions applicable within the department and when necessary, implement them
• Ensure in-depth review of clinical study documents for consistency (within and between documents), quality check, editing and formatting, in full compliance with relevant requirements: these documents will all be related to clinical studies (e.g. protocols, reports, investigator's brochures, ICFs, etc…)
• Contribute to the preparation of regulatory dossiers for submission to regulatory authorities, including writing, reviewing, formatting and editing the appropriate sections
• Ensure that scientific/clinical documents for external presentations (abstracts, posters) or for publication in peer-reviewed journals comply with the appropriate requirements (including reference styles and consistency)
• Ensure that clinical studies are registered on ClinicalTrials.gov and that the results of the terminated studies are disclosed
• Implement, maintain and improve the quality system: apply, review, update and create (if applicable) work instructions, standard operating procedures and document templates

• Advanced degree (or clinically relevant degree) in life sciences/healthcare
• Fluency in English (written)
• Excellent scientific/medical writing skills
• Excellent proficiency in Word, Reference Manager, Excel and Powerpoint softwares
• Capability to interpret, discuss and represent study- or program-related data
• Interpret and report results effectively
• Profound technical and operational experience in medical writing, preferably in the field of clinical research
• Strong interpersonal skills and good team player
• Ability to deliver in tight and changing timelines
• Good understanding of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process would be a plus