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Clinical Review Specialist
2 months ago
Position Overview
Lilly is seeking a highly skilled Clinical Review Specialist to join our Medical Affairs team.
As a Clinical Review Specialist, you will play a critical role in reviewing and approving medical content to ensure it meets the highest standards of accuracy, quality, and regulatory compliance.
You will collaborate closely with cross-functional teams, including Marketing, Medical, and Regulatory, to ensure that all content is scientifically accurate, compliant with regulatory requirements, and aligned with Lilly's brand strategy.
Key Responsibilities
Review and approve medical content, including promotional materials, clinical trial documents, and scientific publications, to ensure they meet regulatory requirements and Lilly's quality standards.
Collaborate with cross-functional teams to develop and implement content strategies that support business objectives and regulatory requirements.
Participate in content review meetings and provide scientific and clinical input to ensure content is accurate, compliant, and aligned with Lilly's brand strategy.
Develop and maintain knowledge of regulatory requirements, industry trends, and Lilly's policies and procedures.
Identify and escalate potential quality issues or compliance risks to management.
Requirements
Bachelor's degree in a scientific or health-related field, or equivalent experience.
2-4 years of experience in a related field, preferably in a pharmaceutical or medical device company.
Strong understanding of regulatory requirements, including FDA regulations and ICH guidelines.
Excellent scientific and clinical knowledge, with the ability to apply this knowledge to review and approve medical content.
Strong communication and collaboration skills, with the ability to work effectively with cross-functional teams.
Preferred Qualifications
Master's degree in a scientific or health-related field, or equivalent experience.
Experience in a related field, preferably in a pharmaceutical or medical device company.
Knowledge of Lilly's policies and procedures, as well as regulatory requirements.
Experience with content management systems and regulatory compliance tools.
