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Senior Clinical Scientist

2 months ago

Rahway, New Jersey, United States Astrix Full time

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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