Sr. Scientist Clinical Science Cp

Vor 5 Tagen

Allschwil, Schweiz Johnson & Johnson Vollzeit

**Job Function**:
Discovery & Pre-Clinical/Clinical Development
**Job Sub Function**:
Clinical Development & Research - Non-MD
**Job Category**:
Scientific/Technology
**All Job Posting Locations**:
Allschwil, Basel-Country, Switzerland

**Principal responsibilities**
- Contributes to the development of the clinical study protocol and of other clinical study documents, e.g. Informed Consent Form, Case Report Form, etc.
- Monitors daily activities of clinical studies which require scientific input, e.g. contribution to answers to trial-related Health Authorities' (HA) questions, answer to Ethic Committees /Institutional Review Boards questions, etc.
- Performs medical monitoring/ reporting including evaluation of adverse events. Participates in the review, evaluation and reporting of clinical study results.
- As requested, assist in managing study-related committees, external medical experts etc.
- Ensures that all activities are in compliance with department, company and regulatory standards and procedures.
- As requested, participates on cross functional teams, e.g. improvement of processes, etc.

**Required qualifications and experience**
- PhD, PharmD, DVM, MSc (or equivalent) degree in Biological Sciences required.
- At least 3 years experience in Clinical Development, and hands on experience on conducting clinical trials.
- Knowledge of clinical development processes, clinical trial processes, and regulatory requirements/ ICH guidelines based on previous deliverables.
- Prior experience of working in a matrix organization including interactions with all relevant functions involved in a clinical trial and program (e.g. Biostatistics, Data Management, Operations, Regulatory, Drug Safety, external service providers, etc.) advantageous.
- Excellent computer systems and software skills.
- Excellent English, other languages advantageous.

**Competencies**
- Good organizational skills, good written and verbal communication skills, able to work as part of a team and independently
- Good independent time management skills advantageous
- Ability to work well in a dynamic environment and be able to prioritize and respond to changing needs of the business.
- Detail oriented.

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