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IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics, and human ingenuity to drive healthcare forward.

To our Real World Evidence unit we are currently seeking RWE Regulatory Champion - an individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline.

Main responsibilities:

• Acts as a Regulatory Team Leader on more complex projects, which may include technical writing;
• Prepares and reviews regulatory documentation,
• Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments;
• Acts as an SME in Regulatory knowledge in Chemistry, Manufacturing and Controls, Lifecycle Maintenance, Marketing Authorization Transfers, Labeling, Publishing;
• May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development;
• May present to clients on complex regulatory processes at large full service kick off meetings by phone or in person;
• May act as reviewer for regulatory standard operating procedures,
• May prepare and deliver regulatory training to IQVIA small groups or individuals.

Qualifications

• Bachelor's or Master's Degree Degree in Life Science or related discipline;
• At least 3-4 years relevant regulatory experience;
• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines;
• Good, solid interpersonal communication (oral and written) and organization skills;
• Ability to establish and maintain effective working relationships with coworkers, managers and clients;
• Strong software and computer skills, including Microsoft Office , publishing applications and tools, as applicable;
• Demonstrates self-motivation and enthusiasm;
• Ability to work on several projects, with direction from senior staff as appropriate;
• Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements;
• Ability to make decisions on discrete tasks under senior supervision;
• Ability to adapt quickly to a rapidly changing environment;
• Applicable certifications and licenses as required by country, state, or other regulatory bodies

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com