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 clinical research, medical writing, or clinical science in the medical device or pharmaceutical industry Familiarity with clinical trial design, biostatistics, and Good Clinical Practice Ability to interpret regulatory standards and guidance Experience working with external partners and/or regulatory bodies, including the FDA

Mar 22, 2025 - 05:50

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 clinical research, medical writing, or clinical science in the medical device or pharmaceutical industry Familiarity with clinical trial design, biostatistics, and Good Clinical Practice Ability to interpret regulatory standards and guidance Experience working with external partners and/or regulatory bodies, including the FDA