- Develop a thorough understanding of scientific and medical aspects to prepare key documents (e.g., Investigator Brochures, regulatory submission documents, presentations).
- Write, review, amend, and facilitate cross-functional processes for protocol preparation.
- Provide insights, review cross-functional trial materials, and oversee data review and medical oversight.
- Oversee study planning adequacy and direct clinical program implementation.
- Manage project budgets, prioritize timelines, and ensure adequate staffing.
- Participate in ongoing data review processes and present at investigator meetings.
- Engage in ad hoc discussions, contribute to document standardization and procedural refinement.
- Participate in corporate committees and assist in special projects as needed.
- Contribute to cross-functional and clinical development initiatives and processes as required.
- PhD, Pharm D, MSc, or equivalent degree in life or health sciences.
- Minimum of 2 years' experience in medical or technical writing.
- Immunology experience is highly valuable.
- Clinical monitoring experience is preferred.
- Strong medical/scientific and clinical research knowledge.
- Familiarity with clinical trial design, basic statistics, pharmacodynamics, and pharmacokinetics.
- Proficient in data interpretation.
- Experience in protocol development, study report preparation, Investigator Brochure preparation, and regulatory submissions.
- Comprehensive understanding of the drug development process.
- Knowledge of GCP and ICH Guidelines.
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Clinical Scientist - Basel, Schweiz - headcount AG
Beschreibung
Clinical ScientistLocation: Basel (hybrid).
Start: ASAP
Duration: 6 months
Workload: 100%
Our client, a Swiss Pharmaceutical company specializing in innovative medicines for rare diseases, is in the process of launching their first commercial product. They are seeking a Clinical Scientist to provide scientific and medical expertise to various products across various stages of clinical development to facilitate regulatory submissions.
Your tasks:
**Please only apply if you are eligible to work in Switzerland and the EU**
headcount AG
Nutzer der Berufsbezeichnung Clinical Scientist in Basel
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Mac H. Ramos F.
Senior Medical Advisor
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Sebastian Baumann
Regulatory Affairs
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Susanne Globig
Expert in regulated Bioanalysis