Lifelancer
51 - 200 employees
Founded 2020
🤖 Artificial Intelligence
🧬 Biotechnology
💊 Pharmaceuticals
💰 Pre Seed Round on 2022-03
Artificial Intelligence • Biotechnology • Pharmaceuticals
Lifelancer is an AI-powered talent hiring platform that connects employers with skilled professionals in the Life Sciences, Pharmaceutical, and IT sectors. It enables individuals to create profiles showcasing their skills, get matched with high-paying international jobs or projects, and facilitates hiring and payroll for employers in multiple countries. The platform aims to streamline the hiring process with efficient AI sourcing and compliance support.
Regulatory & Site Activation Specialist
Job not on LinkedIn
🔥 0 minutes ago
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Lifelancer
51 - 200 employees
Founded 2020
🤖 Artificial Intelligence
🧬 Biotechnology
💊 Pharmaceuticals
💰 Pre Seed Round on 2022-03
Artificial Intelligence • Biotechnology • Pharmaceuticals
Lifelancer is an AI-powered talent hiring platform that connects employers with skilled professionals in the Life Sciences, Pharmaceutical, and IT sectors. It enables individuals to create profiles showcasing their skills, get matched with high-paying international jobs or projects, and facilitates hiring and payroll for employers in multiple countries. The platform aims to streamline the hiring process with efficient AI sourcing and compliance support.
📋 Description
• Liaise with SAR colleagues to drive plan, organize, compile, progress, track, and submit regulatory submissions on a timely basis and with a consistently high level of quality. • May act as a contact point for translation review of submission documents such as applications, synopses, ICFs, labels, etc. • Maintain country-specific patient information sheet and consent form customization text. • Maintain country-specific drug labeling information and Country Intelligence Pages. • Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country-specific requirements.
🎯 Requirements
• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related sciences • Minimum three years of experience in clinical research, preferably in site activation and/or regulatory-related function • Previous experience within the pharmaceutical/CRO industry. • Thorough knowledge of ICH GCP, EU Clinical Trials Directive, and other relevant guidance on conducting clinical research. • Experience in regulatory submissions in Australia • Multilingualism preferred; working knowledge of English.
🏖️ Benefits
• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options
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