Senior Start Up & Regulatory Specialist

🔥 0 minutes ago

🇹🇷 Turkey – 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.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 within assigned country/sites and foresee and mitigate risks • Drive country-level submissions and site activation processes • Prepare Clinical Trial Application forms and submission dossiers for authorities, ethics committees, and applicable local bodies • Interact with Competent Authorities and Ethics Committees and handle responses • Provide submission updates to Start Up/Regulatory Leads and Project Managers/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 assigned site CRA 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 required for submissions • Communicate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams regarding status and deliverables • Maintain site-level critical-path data for activation timelines, contracts, budgets, and required reviews • Support study budget negotiation and investigator contract execution when required • Maintain knowledge of local clinical-trial laws and regulations and distribute knowledge internally • Maintain audit/inspection readiness and file documents according to TMF or study-specific plans • Support Pre-Study Site Visits and feasibility site outreach when needed • Support country-specific start-up summaries, process flows, training sessions, and SME responses • Mentor staff on local regulations, submissions, procedures, guidance, and tools • Own departmental process improvements and initiatives • Provide clients with activation-readiness updates and support proposals, presentations, and KOMs • Act as Start Up Lead for smaller/single-country studies or regional Start Up Lead for larger global studies

🎯 Requirements

• Bachelors’ degree in life sciences or related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience • 5 years or more as a Regulatory or Start Up Specialist in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies • Excellent communication and organizational skills • Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail • Fluency in English and Turkish • Ability to prioritize workload to meet deadlines • Experience driving cross-functional activities, coordination, and oversight of a team • Relevant regulatory and site start-up experience for Turkey, including feasibility, contract negotiations, and CA/EC/IRB submissions • Experience using milestone tracking tools/systems • Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements • Excellent computer, communication, presentation, and interpersonal skills • Occasional travel may be required

🏖️ Benefits

• Employees are appreciated for their contributions • Employees’ input and ideas are valued and nurtured • Equal Opportunity Employer • Reasonable accommodation available during the application process