Medical Writer & Clinical Study Manager

Job description

WHY WE NEED YOU:

At Nicolab, we believe connecting human and artificial intelligence will revolutionize emergency care. We develop end-to-end solutions to further empower physicians in emergency care. We are growing globally and therefore looking for a Medical Writer & Clinical Study Manager who will expand market reach by getting regulatory approval for its expanding groundbreaking product portfolio of AI-powered software solutions for stroke diagnosis. We want you to join our growing team of regulatory and clinical experts to lead our efforts of providing clinical evidence for getting clearance of our products in international markets by developing, planning, managing and reporting clinical evaluation efforts according to specific regulatory requirements.


WHAT YOU'LL DO:

  • Assemble technical files for our products according to regulatory requirements

  • Train our customers and partners to gain the maximum value from our clinical solutions

  • Developing, managing, and conducting clinical evaluations and clinical investigation studies in accordance with regulatory requirements (FDA, MDR, etc.)

  • Documentation of clinical evaluations and clinical investigation studies

  • Conduct systematic literature reviews and state-of-the-art evaluations

  • Prepare and review clinical study documentation in accordance with ISO 14155

  • Plan, manage & report Post Market Surveillance activities

Job requirements

WHAT YOU’LL BRING

You have experience as a medical writer and clinical study manager in a small or medium-sized medical device company, university, or research institution. You have worked with AI-powered software as a medical device. You have the practical experience and theoretical knowledge in developing, managing, conducting, (statistical) analyzing and reporting of clinical research. You have scientific research experience.

WHAT WE'RE LOOKING FOR

  • Experience as a medical writer and/or clinical study manager

  • Master, MD or preferably PhD in Science, Engineering, Medicine or similar (or comparable experience in research)

  • Understanding of international (ISO 14155) and market-specific (MDR, etc.) clinical study requirements in Europe and/or USA and preferably other markets.

  • Excellent writing & reading skills in English

  • Editorial/proofreading skills

  • Excellent attention to detail and quality

  • Experience in technical set-up of reader studies and processing of data


WHAT WE OFFER:

  • Chance to make a real difference to patient’s lives

  • A fun and ambitious work environment

  • Pension contribution

  • Additional 8% holiday pay

  • Flexible working hours

  • Travel expenses by car, train or bike

  • Work laptop (Apple or other)

  • Stimulating environment with a fun motivated team


WHO WE ARE:

We believe the combination of artificial and human intelligence will revolutionize emergency care and we work each day to make that happen. Founded in 2015 as a spin-off from the Amsterdam University Medical Center, our research background continues to drive our way of thinking.

We have a diverse team from all corners of the world, composed of researchers, developers and experienced medical specialists who ensure our product and services match our clients' needs. We're first tackling the major issue of stroke, the leading cause of life-long disability, where we will ensure every patient gets the right treatment in time.