Clinical Project Physician MD (m/w/d)

Basel  ‐ Vor Ort
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Beschreibung

Clinical Project Physician (MD)

Location: Basel

Duration: 12 months

Tasks:

The Project Physician is a responsible member of a clinical team dedicated to the development and execution of medical strategies and the clinical and operational implementation of a complex compound program.
  • Provide active medical and scientific contribution to a cross-functional clinical team.
  • Provide input to the clinical development plan, work on the development of the clinical trial protocol, clinical trial materials, and take ownership for the content of clinical study reports and relevant documents for regulatory filings.
  • Responsible for medical monitoring/reporting and company safety officer activities
  • Evaluate adverse events (pre and post-marketing) for relationship to treatment
  • Assist Regulatory Affairs in determining requirements for any corrective actions or health authority reporting
  • Act as a medical contact at the company for health authorities concerning clinical/medical issues
  • Interpret, report and prepare oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions
  • Support general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance
  • Review medical literature and related new technologies
  • Team matrix interactions include project management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs, data management, medical writing, biostatistics, global medical affairs, clinical pharmacology, clinical operations, health economics, epidemiology and other scientific and business related disciplines.


Requirements:
  • 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 and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
  • Specific experience in phase II and III studies is a strong advantage.
  • Submission experience a strong advantage.
  • Experience in medical review
  • Fluent in written and spoken English


Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
Start
10/2021
Von
Real Staffing
Eingestellt
28.09.2021
Projekt-ID:
2214898
Vertragsart
Freiberuflich
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