Senior Regulatory and Start Up Specialist, Mexico

🔥 0 minutes ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🚔 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, high-quality site activation readiness for assigned Mexico sites 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/Regulatory Leads 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 • Partner with site CRAs to align communication and secure site collaboration • Prepare, 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 regarding status and deliverables • Act as subject matter expert for site activation critical-path data, timelines, contracts, budgets, and reviews • Support study budget negotiations and investigator contract execution when required • Maintain knowledge of local clinical trial laws and regulations and distribute regulatory knowledge internally • Maintain audit/inspection readiness and file documents in the relevant TMF • Support pre-study site visits, feasibility outreach, country start-up summaries, training, mentoring, client updates, and proposal activities as needed • Perform other duties assigned by management

🎯 Requirements

• Bachelor’s degree in life sciences or related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience • 3.5 years or more as a Regulatory or Site Start-Up specialist in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies • Professional-level English proficiency • Fluency in English and the local language of the country where the position is based • Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail • Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements • Excellent communication, organizational, presentation, interpersonal, and computer skills • Ability to prioritize workload, meet deadlines, work independently in a fast-paced environment, and interact effectively with project teams • Occasional travel may be required • Candidates must be legally authorized to work in the country of employment without employer sponsorship

🏖️ Benefits

• Remote work in Mexico • Regular full-time employment • Occasional travel may be required