Regulatory and Start-Up Specialist

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Deliver timely, high-quality site activation readiness for assigned countries/sites and foresee and mitigate risks • Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies • Interact with Competent Authorities and Ethics Committees and handle responses • Provide submission updates to Start Up and Regulatory Leads, Project Managers, and project teams • Maintain project plans, trackers, and regulatory intelligence tools • Prepare or support study-specific start-up plans, IMP release requirements, and essential document review criteria • Partner with assigned site CRAs to align communication and secure site review and collection of essential documents • Customize country/site-specific Patient Information Sheets and Informed Consent Forms • Facilitate document translations and coordinate translation activities • Communicate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams regarding status and deliverables • Act as subject matter expert for site-level critical-path data supporting site activation • Support study budget negotiations and investigator contract execution when required • Support feasibility activities and investigator site outreach when needed • Maintain knowledge of local clinical trial laws and regulations and distribute regulatory knowledge within Precision for Medicine • Maintain audit and inspection readiness and file documents according to TMF and study-specific plans • Support clinical teams performing Pre-Study Site Visits

🎯 Requirements

• Bachelor’s degree in life sciences or related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience • Demonstrated experience as a Regulatory or Start Up Specialist, or in a comparable CRO, pharmaceutical, or biotechnology role, or equivalent relevant experience and/or demonstrated competencies • If applying from Romania, speak Romanian, Hungarian, and English • Strong communication and organizational skills • Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail • Fluency in English • A qualification in Pharmacy or work experience as a Pharmacist would be highly beneficial • Preferred experience with regulatory and site start-up activities, milestone tracking tools/systems, and workload prioritization • Advanced degree in medical or life sciences, RAC certification, or Master’s in Regulatory Science preferred