Parexel
10,000+ employees
Founded 1983
💼 Consulting
🏥 Healthcare
📦 Logistics
💰 Venture Round on 1990-01
Consulting • Healthcare • Logistics
Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.
Regulatory Affairs Consultant – Core Team
🕒 August 7
Where this job comes from
Posted on Parexel's careers page, not through a job board
First seen by Remote Rocketship August 7
Still open on Parexel's site. Checked 3 days ago.
Parexel
10,000+ employees
Founded 1983
💼 Consulting
🏥 Healthcare
📦 Logistics
💰 Venture Round on 1990-01
Consulting • Healthcare • Logistics
Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.
📋 Description
• Work within a team environment or independently to deliver services within the technical area of expertise • Prioritize work and define steps needed to achieve specified project outcomes • Produce quality work meeting project team lead and client expectations • Serve as Project Lead for small-scale projects or Work Stream Lead on larger projects when assigned • Plan and set up projects; control project forecasting, financial entries, invoicing, and related activities • Act as the main client contact and ensure accurate project reporting • Ensure project teams meet client expectations for quality and timeliness • Identify risks, escalate issues, maintain training compliance, and manage project financials • Ensure teams understand and work within contract scope • Identify change-in-scope and add-on business opportunities • Complete timely project close-out activities • Follow consulting models and methodologies and provide technical or business consulting services • Collaborate with colleagues and clients to resolve technical and process issues • Assess client needs and develop processes and solutions • Prepare or deliver presentations and training with support from senior colleagues • Mentor junior staff • Build industry relationships and communicate potential new business leads • Participate in project scoping calls and proposal preparation • Complete timesheets, expense reports, CV maintenance, training compliance, deliverable archiving, and internal initiatives • Maintain current industry knowledge and define self-development activities
🎯 Requirements
• Knowledge in Regulatory Affairs Activities, focusing on CTAs (Phase I-IV) for various Therapeutic Areas • Proficiency in Regulations, ideally with some knowledge in New Zealand • Several years of experience in an industry-related environment • Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline • Proficiency in local language and extensive working knowledge of the English language • Project management knowledge • Client-focused approach to work • Results orientation • Teamwork and collaboration skills • Consulting skills • Excellent interpersonal and intercultural communication skills, both written and verbal • Critical thinking and problem-solving skills • Preferred experience: Phase I or Early Phase studies; studies involving Medical Devices, GMOs, Radiopharmaceuticals, Biological Drugs, or labelling for Investigational Medicinal Products • Experience in Quality Documentation and CMC could be a plus • Advanced degree preferred
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