QLS are recruiting for a Clinical Project Physician to join an important project with a Global Pharmaceutical Company at their site based in Basel on a contract basis for one year with possibility of an extension.
? Responsible for medical monitoring/reporting and company safety officer activities
? Works on clinical development plans, trial protocols and takes ownership of clinical study reports
? Evaluates adverse events (pre and post-marketing) for relationship to treatment
? Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting
? May act as a medical contact at the company for health authorities concerning clinical/medical issues
? Interprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions
? Close interactions with Project Scientists and Physicians across programs
Further responsibilities include:
? Assists Regulatory Affairs in the development of drug regulatory strategies
? Helps explore and evaluate new product ideas to assist in identifying new market opportunities
? Support general Clinical/Medical Affairs activities involving product evaluation, labelling and surveillance
? Participate on and may lead cross-functional teams for evaluation of new product ideas, implement franchise business strategies, etc.
? Reviews medical literature and related new technologies
? May be asked to assess medical publications emerging from the Team and its affiliates
? May be responsible, with appropriate colleagues, for review of Company advertising and promotional materials
? MD (or equivalent) in relevant area with appropriate post-doctoral training and certification
? Ideally previous experience in the Pulmonary Hypertension Therapeutic Area, otherwise Cardiovascular/Cardiopulmonary experience is appreciated.
? Experience in medical review.
? Submission experience a strong advantage.
? Fluent in written and spoken English
? Working knowledge of the use of Microsoft suite of software products including Excel and Word
? Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
Please could you send any correspondence in English. Please quote reference 51740 in all correspondence.
You must have the right to work in Switzerland.
- Agency: CK Group
- Contact: Adrien Guimard
- Phone: 01438 723 500
- Reference: 51740
Website: CK Group
- Posted: 24th September 2021
- Expires: 22nd October 2021