Main Duties:
Full support to Regulatory / Clinical Strategy, including:
-Writing and reviewing regulatory documents such as SOP, CER, validations etc
-Support product regulatory submission to FDA, cFDA and EMEA
-Preparation of clinical knowledge scientific documents
-Development and execution of Post-marketing clinical plan
Planning and execution of clinical trials and different clinical activities (MPT, IST, LME) according to GCP and following company SOPs including:
-Contract negotiation, preparation of trial related documentation, IRB, study initiation visits, site monitoring and training, data collection, analysis and reporting, collaborating with physicians towards publication of study results,
Support Business Units activities from the scientific/medical point of view in strategic thinking, planning and execution including:
-Supporting the writing and review of marketing materials and white papers
-Contact person in any communication with leading physicians, KOLs and consultants
-Literature search and providing clinical publication supporting materials
-Active participation in scientific meetings / lectures / congresses.
Support of R&D process of medical devices, including:
-Planning and execution of ex-vivo, in-vivo and clinical trials
-Clinical application requirements
-Risk management process
Support in training according to internal and external needs
Active participation in scientific meetings / lectures / congresses
Support complaints investigations and vigilance report review
Ability and willingness to travel abroad (10%-20%)
REQUIREMENTS
PhD (preferable) or Master’s degree in life sciences
Experience of at least 1-2 years in clinical research in and outside of Israel (Must)
Regulatory/Clinical documents writing
Ability to independently lead clinical research
High interpersonal skills
Fluent in English
Excellent teamwork skills
Strategic thinking
Presentations skills
Leadership skills
