Clinical Affairs Scientist

A company is looking for a Clinical Affairs Scientist to support clinical evidence generation in the medical diagnostic field.

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 the submission process and ensure compliance with clinical affairs processes

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, or clinical science

Familiarity with clinical trial design, conduct, and oversight preferred

Ability to interpret regulatory standards and guidance

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