(Senior) Medical Writer and Searcher

The exciting journey begins today due to expansion of our team! Currently, we are looking for three candidates to join us in the captivating role of Medical Writer and Searcher. Our team's adaptability is the key – allowing us to customize the experience and knowledge requirements based on the unique skills of our candidates. This position serves as the perfect opportunity for both aspiring specialists, eager to kickstart their careers, and seasoned senior professionals hungry for fresh challenges. If you possess a deep passion for conducting thorough information management and research methodology and efficiently retrieve relevant information, if you are enthusiastic about crafting diverse documents, and if you enjoy collaborative work with interdisciplinary teams, we warmly encourage you to submit your application.

Working with us you will receive:

• a chance to develop yourself in a Polish-Danish culture based on openness and trust;
• the opportunity to exchange experiences and develop skills in an international environment;
• a full introductory training;
• full-time work agreement in the international developing organization;
• flexible working hours and hybrid workplace;
• possibility to improve English in daily basis;
• close cooperation with your team and manager - Laura Bednarz

What tasks are waiting for you:

• Prepare Clinical Evaluation documents (clinical evaluation plans, clinical evaluation reports, post-market clinical follow-up reports) according to the applicable regulations (including MDR (EU) 2017/745) and internal procedures.
• Prepare post-market surveillance documents).
• Work with stakeholders to gather relevant information.
• Perform information searches in for example scientific databases like PubMed, Cochrane etc.
• Appraisal and analysis of clinical data from the literature.
• Maintain current clinical evaluation plans and reports as well as post-market surveillance reports.
• Develop and maintain processes for clinical/regulatory writing.
• Monitor, evaluate and implement regulatory requirements relating to the areas of responsibility within Clinical Affairs; Clinical Evaluation and Post Market Clinical Follow-up.
• Secure the level of evidence required to achieve regulatory compliance for areas of responsibility within Clinical Affairs.

It would be great if you have: 

• A bachelor’s or master’s degree in audiology, health care, life science, engineering or other relevant technical or scientific degree;
• Experience in preparing clinical evaluation plans and reports for EU MDR class I and IIa (active) medical devices;
• Knowledge of clinical research methodology and regulatory requirements;
• Experience in information management, data analysis, literature search and review;
• Demonstrated technical and medical writing competence;
• Proficient in English – written and spoken;
• Excellent written and verbal communications skills;
• Strong organizational skills, attention to detail and proofreading skills;
• Experience in project management.

If you have more questions, please contact our recruiter Kasia (kmas@dgs-diagnostics.com)

Please send us your CV in English.

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