Senior Specialist, Study Start Up – Regulatory Affairs

🔥 50 minutes ago

🌐 New Zealand, Serbia – Remote

🇳🇿 New Zealand – Remote 🇷🇸 Serbia – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 16%

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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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Lead and coordinate activities required to achieve site initiation readiness • Deliver assigned study start-up and regulatory milestones within scope • Make independent decisions regarding regulatory processes and documentation approaches • Lead study start-up and regulatory activities for assigned countries or medium-complexity projects • Prepare, review and quality-control regulatory and study start-up documentation, submissions, essential documents and translations • Draft, negotiate, finalize and execute clinical site agreements, ancillary agreements and amendments • Collaborate with legal, finance, clinical operations, sponsors, monitors and other functional teams • Conduct site outreach and serve as point of contact for assigned sites • Coordinate document processing leading to investigational product release and site activation readiness • Review labels, patient information sheets, diary cards, insurance and related documentation for compliance • Provide regulatory and study start-up strategic input • Develop regulatory strategies, study start-up plans, joint operating procedures and core documents • Identify and escalate project risks and support corrective/preventive actions • Monitor project budgets and hours against budget, escalating out-of-scope work • Provide expert advice to clients on complex regulatory queries and liaise with authorities • Act as country or regional subject matter expert for regulatory and clinical study activity elements • Maintain country intelligence repositories and disseminate regulatory changes • Complete project trackers, correspondence logs, study portal/TMF filing and submission dossier quality control • Support business development proposals, budgets and meetings • Comply with SOPs, work instructions, training records and timesheet requirements • Support junior staff with audits and inspections • Contribute to SOPs, working practices and company initiatives • Train, coach and mentor junior staff • Perform other assigned duties

🎯 Requirements

• Graduate degree in Chemistry or Life Sciences, Pharmacy, MD, or equivalent combination of education and experience • Previous experience within the pharmaceutical/CRO industry • Good knowledge of ICH GCP and national regulations for territories of competency • Proficiency in English, both written and verbal • Good written and verbal communication skills • Excellent planning and organizational skills • Strong planning, strategizing, managing, monitoring, scheduling, problem-solving and critiquing skills • Ability to manage multiple tasks, set priorities, and adapt to changing work assignments • Ability to exercise sound judgment and make decisions independently • Remarkable attention to detail • Excellent self-motivation and motivation skills

🏖️ Benefits

• Work-life balance • Collaborative, international team environment • Career growth opportunities • Trusted to take ownership early • Passionate and collaborative team of experts • Training, coaching and mentoring opportunities