Regulatory Maintenance Associate (Clinical Trials) - Bloemfontein at IQVIA

Job Description

• Prepares and/or reviews regulatory documents to support clinical trial submissions. With guidance from senior staff, provides regulatory support for more complex projects.
• Acts as a Clinical Trial Regulatory Manager (CTRM) on straightforward projects independently and complex regulatory projects under the guidance of senior staff.
• Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers.
• Prepares and maintains core clinical trial submission dossiers in accordance with applicable regulatory requirements.
• Interacts with internal and external clients to provide regulatory guidance and strategic input for clinical trials.
• May strategically plan and perform/support European centralized submissions and facilitate global submissions with minimal supervision.
• Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.
• Ensures high quality in all regulatory deliverables
• Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or IQVIA).
• Ability to participate in audits relating to Projects and Systems.
• May perform additional tasks as deemed appropriate by Line Manager

Required Qualifications

• Bachelor's Degree Degree in Lifescience or related discipline
• At least 1-2 years relevant experience with EU CTIS, Global core pack knowledge
• Experience in country oversight particularly for amendments
• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
• Strong software and computer skills, including Microsoft Office, CTMS, SA WF, SAFE, Wingspan, as applicable;
• Possesses a specific regulatory or technical expertise;
• Good, solid interpersonal communication (oral and written) and organisation skills;
• Ability to establish and maintain effective working relationships with coworkers, managers and clients;
• Demonstrates self-motivation and enthusiasm;
• Ability to work on several projects, with direction from senior staff as appropriate;
• Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements;
• Ability to make decisions on discrete tasks under senior supervision.