Regulatory and Start Up Specialist

🔥 13 hours ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 Ghost score 21%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 and high-quality site activation readiness for assigned countries and sites while identifying and mitigating risks • Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, and other applicable local bodies • Interact with Competent Authorities and Ethics Committees and handle responses • Provide regular submission updates to Start Up Leads, Regulatory Leads, Project Managers, and project teams • Maintain project plans, project trackers, and regulatory intelligence tools • Support development of study-specific start-up plans, IMP release requirements, and essential document review criteria • Partner with assigned site CRAs to align communication and secure site activation • Review and manage essential documents required for site activation and IMP release • Customize country/site-specific Patient Information Sheets and Informed Consent Forms • Coordinate document translations • Communicate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts Management teams regarding status and deliverables • Maintain site-level critical path data for Competent Authority, IRB/Ethics Committee timelines, site contracts, budget negotiations, and other reviews • Support study budget negotiations and investigator contract execution • Support feasibility activities and site outreach • Maintain knowledge of local clinical trial laws and regulations and share 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 • At least 2 years of relevant experience • Previous experience as a Regulatory and Start Up Specialist or Site Contracts Specialist in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies • Experience with regulatory submissions • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail • Fluency in English • Relevant regulatory and site start-up experience, including feasibility, contract negotiations, and CA/EC/IRB submissions • Experience in site contract and budget negotiation would be a strong plus • Experience using milestone tracking tools/systems • Advanced degree in medical or life sciences, RAC certification, or Master’s in Regulatory Science are preferred • Must be legally authorized to work in the country of employment without employer sponsorship

🏖️ Benefits

• Regular full-time employment • Remote work arrangement • Equal Opportunity Employer • Reasonable accommodation available during the application process