Regulatory and Start Up Specialist

🔥 26 minutes ago

🇩🇪 Germany – 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 • 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 Leads, Regulatory Leads, Project Managers, and project teams • Maintain project plans, trackers, and regulatory intelligence tools • Support study-specific start-up plans, IMP release requirements, and essential document review criteria • Coordinate with assigned site CRAs to align communication and secure sites • Review and manage essential documents 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 teams • Maintain site-level critical-path data for regulatory, ethics committee, contract, and budget requirements • Support study budget negotiations and investigator contract execution • Support feasibility 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 in the relevant TMF • Support Pre-Study Site Visits when required

🎯 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 or Start Up Specialist in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies • Strong communication and organizational skills • Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail • Fluency in English and German • Qualification in Pharmacy or work experience as a Pharmacist highly beneficial • Relevant regulatory and site start-up experience preferred • Experience in site contract and budget negotiation preferred • Experience using milestone tracking tools/systems preferred • Advanced degree in medical or life sciences, RAC certification, or Master’s in Regulatory Science preferred

🏖️ Benefits

• Regular full-time employment • Remote work arrangement • Equal opportunity employment • Reasonable accommodation support for applicants with disabilities