Clinical Affairs Scientist

A company is looking for a Clinical Affairs Scientist.

Key Responsibilities

Provide thought leadership on clinical topics to support strategy development and execution

Generate content for external validation studies, including study design and authoring protocols and reports

Collaborate with regulatory and development teams during submission processes and author clinical performance documentation

Required Qualifications

Master's degree or advanced degree in pharmaceutical, medical, or relevant biomedical science fields

4+ years of experience in IVD product development, clinical research, medical writing, or clinical science

Familiarity with clinical trial design, conduct, oversight, and Good Clinical Practice

Experience working with external partners and / or regulatory bodies, including the FDA

Knowledge in oncology, immunology, and / or pathology preferred