Clinical Development Specialist (BB-49351)
Gefunden in: Neuvoo CH
Established in 1921 in Switzerland, Sintetica is now in its first century of activity and growth. Leader in its field in Switzerland, Sintetica is a pharmaceutical company delivering injectable anesthetics and analgesics to patients worldwide through innovative solutions with excellence in development, production and marketing.
People are our most valuable asset and our values put the patient and the quality of our products at the heart of our business. That is why we believe in the Great Place to Work culture that promotes creativity and informed risk-taking in an exciting and comfortable work environment.
To strengthen our Clinical Development Department at our headquarter in Mendrisio (Switzerland), we are currently looking for a Clinical Development Specialist (fulltime position).
The Clinical Development Specialist will manage and support the clinical development of the global company portfolio (a mix of established products and innovative therapies), following all the phases of clinical projects, starting from the clinical trial design until the submission of the registration dossier.
She/He will operate under the direct coordination of the Clinical Development Corporate Manager and in collaboration with the Clinical Development Team and the Scientific Affairs Department. She/He will be the projects' scientific reference point for all the relevant internal and external stakeholders.
Essential tasks and responsibilities
- Responsible for clinical research and development projects.
- Coordination and support of the strategic activities related to the assigned project.
- Provides scientific expertise to functional areas such as marketing, non-clinical development, pharmacovigilance and regulatory affairs in accordance with the company's strategy.
- Overview of clinical study protocols and other critical documents.
- Support to clinical operations and scientific supervision during clinical trials.
- Preparation of scientific advices with EU and US authorities.
- Medical writing: contribution to the preparation of pre-clinical and clinical (CTD modules 2, 4 and 5) sections for FDA and EMA dossiers, preparation of EU Pediatric Investigation Plans (PIP), US Pediatric Study Plan (PSP), Investigator Brochures, Briefing Documents, answers to objections, etc.
- Support during European Authorities and FDA GCP inspections.
Required skills and core competences
- Master's Degree in health-related subjects (e.g., pharmacy, biotechnology, biology, or similar disciplines).
- Previous experience in the pharmaceutical industry of 3-5 years.
- Fluent in written and spoken English.
- Excellent communication skills, proactivity, autonomy, precision, teamwork aptitude.
- Management and organizational skills, flexibility, learning agility and strategic thinking.
- Commitment to continuous improvement.
- Adaptability to a multicultural environment.
Fulltime permanent employment in a young work environment and positive culture.
Sintetica promotes diversity and gender equality.
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