Solstice Pharmaceuticals is an innovative scale-up company dedicated to creating next generation ultrasound products. We develop, manufacture and commercialise monodisperse medical microbubbles and associated cartridge systems for a wide variety of diagnostic and therapeutic ultrasound applications. From patient-friendly diagnostics for young children to revolutionary drug delivery systems for neurological diseases.
In this phase of accelerated growth and development, we are searching for a Medical Affairs Specialist to contribute to our successful clinical transition and oversee our crucial clinical studies. The offices and cleanroom facilities of Solstice Pharmaceuticals are situated in Enschede, the Netherlands.
This position reports to the Managing Director. The Medical affairs specialist plays an important role within Solstice by preparing the clinical phase of our product development. This position is responsible for coordinating our various clinical studies. This position will ensure that the patient and positive health outcomes are always central to the development of Solstice. This role is for 24 to 40 hours per week.
- You have a BSc degree or higher of theoretical and practical study in pharmacy, medicine, biology or a similar science based study and have significant experience in pharmaceutical or medical device industry
- You have in-depth knowledge of European and USA clinical regulatory frameworks including Helsinki declaration, GCP and FDA guidelines
- Knowledge of the medicinal product regulatory framework and the medical device regulatory framework is desirable
- You are trained in SUSAR, ASR , DSUR and PSUR or similar reporting
- You are familiar in mathematics, data analysis, and statistical methods
- You work well in multidisciplinary and international teams
- You are familiar with Quality management systems and regulatory laws
- You are willing to travel
- You are comfortable in a dynamic environment of a small organisation and calm under pressure
- You are motivated and work in a structured and accurate manner
- You are willing to take initiative and responsibility when needed
- You strive for optimal quality in your own work and that of others
- You are curious and practical with a strong eye for detail
- You are communicative and a good listener with strong interpersonal skills
- You are able to communicate on a professional level in English both written and orally
- While Dutch is not required, it would be an asset
What you will do
- You will liaise with key opinion leaders, clinical research coordinators, medical ethics committees, regulatory authorities and other stakeholders
- You will gather and share within the organisation market intelligence including knowledge gained from clinical trials
- You will support and monitor clinical trial sites through evaluation, auditing and regular on-site visits
- You will develop and review clinical research protocols for new products or new indications
- You will supervise, clinical trials, trial sites and activities to ensure adherence to appropriate industry protocols and terms of the study
- You will collect, authenticate, maintain and review data collection in particular case report forms, consent forms, regulatory forms and administration records
- You will protect scientific integrity by documenting and reporting adverse effects observed during clinical trials
- You will compile and prepare final reports from individual clinical trials
- You will coordinate with ethics committees to safeguard the rights, safety and wellbeing of all research subjects and their personal information as well as safeguarding for the research activities
- You will develop and execute health economics and outcomes studies for long-term data and return on investment for new products including on variables such as medical costs and patient quality of life
- You will support and run education programmes for healthcare practitioners including training clinicians on trial procedures
- You will ensure compliance with clinical trial guidelines, Good Clinical Practice and FDA regulations
- You will ensure open working practice by registering and reporting clinical trials on appropriate open databases
What we offer
We offer you a challenging position in a fast-growing company in which you can truly make a difference. We offer a competitive salary with attractive employment conditions including a good work-life balance, flexibility in work hours and an attractive share package. Additionally, we are dedicated to offering personal growth and development possibilities within our organisation.
To apply for this position, please send your CV and motivation letter to: email@example.com
Solstice Pharmaceuticals B.V.
Josink Esweg 36
7545 PN Enschede
No recruitment agencies please.