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Clinical Scientist - Ocrelizumab Clinical Science(m/w/x)
Supporting Ocrelizumab clinical science development, including protocol writing and CRF construction. Bachelor's degree in life sciences required, with 0-3 years clinical development experience. Cross-functional coordination and global trial regulations familiarity.
Requirements
- Bachelor’s Degree required (life sciences preferred)
- Advanced Clinical/Science Degree highly preferred (e.g. PhD, PharmD, MSN, MPH)
- 0 to 3 years clinical development experience
- High potential, strong motivation, and willingness to learn
- Familiarity with global clinical trial execution laws and regulations
- Knowledge of medical aspects of GCP, ICH, FDA, EMA guidelines
- Good understanding of drug development multidisciplinary functions
- Therapeutic area relevant clinical trial experience or potential
- Strong collaborative skills
- Ability to work effectively in distributed global team
Tasks
- Support clinical science information development
- Contribute to protocol and ICF writing or amendment
- Construct appropriate CRFs
- Coordinate cross-functionally
- Contribute to internal and external clinical presentations
- Communicate with investigators and study sites
- Prepare patient information and study newsletters
- Present at internal meetings
- Contribute to abstracts and posters
- Prepare content for scientific meetings
- Work with clinical leaders and cross-functional groups
- Execute the Medical Data Review Plan
- Interpret data and contribute to study reporting
- Contribute to CTA and EC written interactions
- Prepare briefing packs and responses to HA questions
- Provide clinical science data for HA interactions
- Contribute clinical data to regulatory submissions
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- GCP
- ICH
- FDA
- EMA
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Clinical Scientist - Ocrelizumab Clinical Science(m/w/x)
Supporting Ocrelizumab clinical science development, including protocol writing and CRF construction. Bachelor's degree in life sciences required, with 0-3 years clinical development experience. Cross-functional coordination and global trial regulations familiarity.
Requirements
- Bachelor’s Degree required (life sciences preferred)
- Advanced Clinical/Science Degree highly preferred (e.g. PhD, PharmD, MSN, MPH)
- 0 to 3 years clinical development experience
- High potential, strong motivation, and willingness to learn
- Familiarity with global clinical trial execution laws and regulations
- Knowledge of medical aspects of GCP, ICH, FDA, EMA guidelines
- Good understanding of drug development multidisciplinary functions
- Therapeutic area relevant clinical trial experience or potential
- Strong collaborative skills
- Ability to work effectively in distributed global team
Tasks
- Support clinical science information development
- Contribute to protocol and ICF writing or amendment
- Construct appropriate CRFs
- Coordinate cross-functionally
- Contribute to internal and external clinical presentations
- Communicate with investigators and study sites
- Prepare patient information and study newsletters
- Present at internal meetings
- Contribute to abstracts and posters
- Prepare content for scientific meetings
- Work with clinical leaders and cross-functional groups
- Execute the Medical Data Review Plan
- Interpret data and contribute to study reporting
- Contribute to CTA and EC written interactions
- Prepare briefing packs and responses to HA questions
- Provide clinical science data for HA interactions
- Contribute clinical data to regulatory submissions
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- GCP
- ICH
- FDA
- EMA
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Roche
Industry
Pharmaceuticals
Description
The company is dedicated to advancing science and ensuring access to healthcare for everyone.
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