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Reg Affairs Officer 2

Aplica ya
Mapa de ubicación: Minato-ku, Tokyo, Japan Full time R1215139

Descripción del trabajo

PURPOSE
Under minimal supervision, manage Investigational Product (IP) to be used in clinical trials according to applicable regulations, guidelines and standard operating procedures (SOPs). Provide input on pharmaceutical aspects of studies.
RESPONSIBILITES
・ Act as IP Management Lead on more complex projects.
・ Ensure that IP activities such as shipment, storage, return and destruction is properly performed through subcontractors.
・ Assist in overseeing compliance and documentation related to IP accountability.
・ During project, liaise closely with sponsor, Clinical Project Manager /Clinical Team Lead and other project team members regarding pharmaceutical matters. Work closely with subcontractors needed for supply and preparation of IP.
・ Ensure that regulatory requirements for import and export of IP and other clinical trial supplies are fulfilled.
・ Assist QA in the preparation of external sponsor audits and regulatory inspections. Respond to internal and external audit/inspection findings in relation to IP.
・ Contribute to the development, review and implementation of SOPs.
・ Provide direction and mentoring to junior colleagues.
・ Ensure that study drug-related documentation is complete and available for archiving on completion of the study
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
・ In-depth knowledge of applicable guidelines such as J-GCP, ICH-GCP and IP-GMP.
・ In-depth knowledge of applicable regulations
・ In-depth knowledge of applicable study SOPs
・ Working knowledge of drug development process
・ Good organizational skills
・ Good oral and written communication skills
・ Good problem-solving skills
・ Effective skill in using MS Office applications, i.e. Outlook, Word, Excel
・ Ability to focus on detail
・ Ability to establish and maintain effective working relationships with co-workers, managers and sponsors
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
・ Degree in life science-related discipline or professional equivalent plus at least 3 years relevant experience* or high school diploma plus at least 7-9 years experience* (*or combination of education, training and experience)
PHYSICAL REQUIREMENTS
・ Extensive use of telephone and face-to-face communication requiring accurate perception of speech
・ Extensive use of keyboard requiring repetitive motion of fingers
・ Regular sitting for extended periods of time
・ Travel will be required

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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