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Senior Clinical Scientist
2 months ago
Experience with COA and PRO endpoint is a MUST
Responsibilities:
- Coordinate global strategic plans for COA/PRO in support of different teams to ensure alignment with product franchise goals
- Assist in selecting and developing COA/PRO instruments for studies
- Provide guidance on implementing COA/PRO instruments following company processes
- Align selection of endpoint measures to meet regulatory and reimbursement requirements
- Prepare COA/PRO sections of evidence packages for regulatory and reimbursement submissions
- Develop, validate, and utilize instruments for measuring COA/PROs in trials and studies
- Conduct literature searches to support COA/PRO strategies
- Produce scientific communications such as abstracts, presentations, and manuscripts
- Stay updated on COA/PRO methodologies and guidelines and share knowledge with study teams
Qualifications:
- PhD (+3 yrs), MS (+5 yrs), or BS (+10 yrs) in relevant field with industry experience in COA
- Familiar with requirements of regulatory and reimbursement agencies for COA/PRO
- Knowledgeable about methodological approaches and technical aspects of COA/PRO
- Ability to interact with different customers
- Strong in project management and communication
- Experience in COA/PRO-related presentations and publications
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