Senior Analyst leading medical communications projects for Costello Medical, managing client deliverables and project teams effectively while ensuring high - quality work standards.
About the role
- Medical Writer preparing clinical evaluation documents and conducting information analysis. Working within Polish-Danish culture and contributing to international collaboration.
Responsibilities
- 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 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.
Requirements
- 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 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.
Benefits
- A temporary replacement agreement or contract of mandate;
- 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;
- Flexible working hours and hybrid or workplace;
- Possibility to improve English in daily basis;
- Close cooperation with your team and manager - Laura Bednarz
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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