Offre: clinical project physician:Randstad.ch
. 26. septembre 2021
. basel, bâle-ville
. life sciences
. audrey bisch, bâle professionals health care & life sciences
. 058 201 55 50
description du poste
Do you want to work in a big pharmaceutical company? Do you have experience in GCP and Pulmonary Hypertension Therapeutic Area or Cardiovascular/Cardiopulmonary? You should then read the following lines!
Our client, based in Basel area, is looking for a Clinical Project Physician for a one year contract.
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. The Project Physician provides active medical and scientific contribution to a cross-functional clinical team. The Project Physician provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and takes ownership for the content of clinical study reports and relevant documents for regulatory filings.
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. The Project Physician may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area
. 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
Other Responsibilities :
. 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, labeling 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
. 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.
. Ideally previous experience in the Pulmonary Hypertension Therapeutic Area, otherwise Cardiovascular/Cardiopulmonary experience is appreciated.
. English Fluent
Do not waste any minutes, apply now! We are looking forward to receiving your application.
Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.