Roche
Healthcare
ClinicalScientistOcrelizumabClinicalScience
“Clinical Scientist - Ocrelizumab Clinical Science at Roche. Skills: Clinical Science, Clinical Development, Regulatory Guidelines. Provide support in developing clinical science information. Contribute to protocol/ICF writing or amendment”
What You'll Achieve.
improving patient experience; expanding access; addressing unmet needs in the MS community; serving younger patient populations
Industry & Context.
What They're Looking For.
Must Have
Bachelor’s Degree required (life sciences preferred), Familiarity with governing laws, regulations, guidelines on global clinical trial execution is required, some knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA and other relevant guidelines and regulation, Good understanding of the multidisciplinary functions involved in drug development
Nice to Have
Advanced Clinical/Science Degree is highly preferred (e.g. PhD, PharmD, MSN, MPH, etc.), prior experience is a plus, Some therapeutic area relevant clinical trial experience or clear potential to assimilate with some support
What You'll Do.
Provide support in developing clinical science information
Contribute to protocol/ICF writing or amendment
Construct appropriate CRFs
Coordinate cross-functionally
Contribute to internal/external clinical presentations
Contribute to study site interactions
Present at internal meetings
Contribute to abstracts
Execute the Medical Data Review Plan
Contribute to study reporting
Contribute to Clinical Trial Application (CTA)/Ethics Committee (EC) written interactions
Contribute to briefing packs
Contribute to written responses to Health Authority (HA) questions
Contribute to clinical science data/preparations for HA interactions
Contribute clinical data input to regulatory submissions
How You'll Work.
Team & Collaboration
coordinate cross-functionally; Work with Lead/senior Clinical Scientists/Medical Directors/Clinical Directors and cross-functional groups; collaborative skills with the ability to work effectively within a geographically distributed global team
Communication Scope
internal/external clinical presentations and communications; investigator meetings; study site interactions; patient information; study newsletters; Study Leadership Team presentations; scientific meetings
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