Medical Writer

Table of Contents

WHAT ARE YOUR MAIN RESPONSIBILITIES?

The Medical Writer is responsible for authoring, reviewing and editing clinical trial-related documents (including regulatory documents) and scientific publications. He / she is responsible for presenting clinical data objectively in a clear, concise format and ensures timely delivery of these documents in accordance with all applicable quality and / or regulatory standards or requirements.

Main Responsibilities :

• Supports the development and writing of clinical and regulatory documents including clinical study protocols and reports, investigator’s brochures, informed consent forms, diverse study plans, annual reports, clinical evaluation reports in accordance with SOP’s of QbD Clinical and / or client and with applicable standards like ICH GCP, ISO 14155 and other regulatory requirements.
• Performs literature reviews for medical devices as part of clinical evaluation reports. Sets up a solid search strategy and conducts a comprehensive literature search using appropriate literature databases. Analyses, appraises and summarizes clinical data (including state-of-the-art reports) and writes literature review plans and reports according to MDR requirements and related guidelines.
• Writes abstracts and publications according to the formatting requirements of the respective journal for publication
• Contributes to the design and maintenance of templates, standards for protocols, marketing materials
• Collaborates and closely interacts with project managers to ensure efficient writing, editing and publishing of clinical study documents and dossiers
• Develops expertise in new areas as needed for the writing activities
• Ensures a consistent style of presentation of documents to maintain quality and ease of review
• Performs quality control review of clinical trial-related documents
• Keeps stakeholders informed on document progress and other project-related information

WHAT DO YOU HAVE TO OFFER?

• Master’s degree in biological or (para-) medical sciences or equivalent by experience.
• Certification as medical writer by acknowledged European (EMWA) or other ( United States) professional organization is considered an additional advantage.
• Minimum of 5 years’ experience in clinical research or equivalent by education or relevant experience if PhD. Otherwise minimum of 10 years’ experience.
• Minimum of 2 years’ experience with systematic literature research
• Knowledge of Medical Devices Regulations and understanding of Clinical Evaluations is a must.
• Minimum of 3 years’ experience in writing study documents, regulatory documents and / or scientific publications
• Strong experience using Microsoft applications (Excel, Word, PowerPoint, Outlook) and advanced features.
• Excellent verbal and written communication skills
• Experience with Medical Devices is a big asset
• Excellent interpersonal skills
• Demonstrates ability to interpret clinical data and communicates scientific or medical information in a clear and concise manner
• Demonstrates ability to understand diverse scientific topics and to address complex issues with a structured approach without loosing oversight of the larger scope
• Demonstrates ability to work independently
• Knowledge of ICH and EU and US regulatory requirements, including requirements for preparation of key clinical and regulatory documents
• Analytical and critical mindset
• Team player with customer-oriented approach and strong sense of urgency
• Demonstrates ability to identify and adapt to shifting priorities and competing demands
• Sensitive to cultural differences
• Fluent in English. Other languages are a plus.

WHAT DOES QbD Clinical, part of the QbD group, OFFER YOU?

We are a healthy company with a strong growth and international ambitions. In addition to an attractive salary package, we can offer you the following advantages :

• We’ve got your back, giving you the opportunity to shape your career.
• Thanks to our flat organization, we have short communication lines and you can always come to us.
• Standing still means going backwards. With our extensive training package and our periodic knowledge-sharing moments, we offer you many opportunities to continuously learn, to expand or specialize your knowledge and skills and to gain new expertise.
• Get to know your colleagues outside the work environment! Teambuilding and fun activities are planned on a regular basis. A comedy night or quiz night? Nothing is too crazy for us!
• In short… We stand for JPEG : Joy in Partnership, going for the Extra mile to Get things done!

Interested? Send us your CV and motivation letter (both in English) and who knows, we might welcome you soon in our QbD group!