Regulatory and Start Up Specialist

🕒 August 11

🇷🇴 Romania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 38%

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, 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 applicable local bodies • Interact with Competent Authorities and Ethics Committees and handle responses • Provide submission updates to Start Up/Regulatory Leads and Project Managers/Project Teams • Maintain project plans, project 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 CRA to align communication and secure site review • Review and manage essential document collection for site activation and IMP release • 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, including authority and ethics timelines, site contracts and budget negotiation requirements • Support study budget negotiations and investigator contract execution when required • Support feasibility activities and site outreach when needed • Maintain current knowledge of local clinical trial laws and regulations and distribute knowledge within Precision for Medicine • Maintain audit/inspection readiness and file documents according to TMF and study-specific plans • 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 • Demonstrated experience as a Regulatory or Start Up specialist, or comparable role, in a CRO or pharmaceutical/biotech industry, 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 • Candidates must be legally authorized to work in the country of employment without employer sponsorship • Pharmacy qualification or pharmacist work experience highly beneficial • Relevant regulatory and site start-up experience preferred • Experience using milestone tracking tools/systems preferred • Advanced degree, RAC certification, or Master’s in Regulatory Science preferred

🏖️ Benefits

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