International Project Manager Science Medical Affairs
Stratpharma, Switzerland
Job Description
A fast growing and innovative Medical Device company based in the centre of Basel have created a totally new role for a Scientific Project Manager to join them in their continued growth and development. This is a highly successful company with significant year on year growth who are expanding globally.
This role will see the successful candidate take on a challenging and broad role that will be heavily involved in the company’s development.
Tasks
- QA Support :
- Environmental scanning. Following internal and ISO SOPs to maintain the PMS obligations of the company
- Assisting in the preparation of Clinical evaluation reports
- Assisting in the preparation of NPD documental process and record keeping
- Regulatory Support
- Product dossier inputs from Clinical results
- Document preparation and assistance
- Stratpharma QMS system support (review, process management analysis and assistance for QARA team)
- Clinical Plan responsibilities:
- Development of clinical documentation (protocol, case report forms, reports)
- Preparing manuscripts
- Marketing cooperation (NPD and existing products):
- Literature review
- Indication analysis, competitive overview, segmentation
- Pricing analysis, reimbursement landscape
- Market Access responsibilities:
- Preparing submission dossiers
- Compiling clinical and scientific information
Requirements
- Minimum of 2 years’ experience in the areas of clinical research preferably in the medical device industry.
- New product development experience desirable
- Clinical trial management experience desirable
- Statistical Analysis experience desirable
- Medical Writing/Scientific Writing experience desirable
- Fluent English essential
Benefits
This is a rare opportunity to get in at the ground floor of an exciting company with continued expansion. The successful candidate shall be able to make the role their own and build their position with the company. This is a small to medium sized company with an excellent culture and a family environment feel. The client is offering a leading salary with high bonus and benefits.