Specialist/Snr Specialist Study Start Up and Regulatory Affairs

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ph3Specialist/Snr Specialist Study Start Up and Regulatory Affairs /h3ulliFull-time /liliDepartment: Study Start up and Regulatory Unit /li /ulpMedicine moves forward here. So willyou. /ppErgomedis a specialist clinical research organization focused on rarediseaseand select oncology indications. We focus on the most complextrials,the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner. /ppWe choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, dataqualityand the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait. /ppThat is why culture matters to us as many as capability. We have built a collaborative, international team where people share ideas, grow theircareersand are trusted to take ownership early. With colleagues across North America, South America, Europe,Asiaand Australia, we value teamwork,flexibilityand a real commitment to work-life balance, because good science comes from people who feel supported. /ppIf you wantworkwith purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you. /ppThe Senior Specialist, Study Start Up and Regulatory Affairs leads and coordinates all activities relatedbr/to achieving site initiation readiness. The role provides subject matter expertise, ensures regulatorybr/compliance, and serves as a key liaison between internal teams, clients,



and external stakeholders /pulliAccountable for delivery of assigned study start-up and regulatory milestones within definedscope. /liliMake independent decisions within assigned scope regarding regulatory processes anddocumentation approaches. /liliHandles medium-complexity regulatory environments, including multi-country requirementswhere applicable. /liliLeads study start-up and regulatory activities for assigned countries or projects of mediumcomplexity, ensuring delivery in line with timelines, quality standards, and regulatoryrequirements. /liliLeads preparation, review, and quality control of regulatory and study start-updocumentation (including submissions, essential documents, and translations) to ensurecompleteness, accuracy, and compliance with ICH-GCP and country-specific requirements. /liliResponsible for drafting, negotiating, finalizing, and executing clinical site agreements,ancillary agreements as well as amendments at country or regional level, in accordance withproject requirements and country regulations and within the projected delivery timelines /liliReview all relevant documentation e.g. labels, patient information sheets, diary cards,insurance etc, to ensure compliance with ICH GCP country specific requirements. /liliContribute towards the preparation and/or review of complex technical/scientific/legaldocumentation.



/liliArrange for and/or review translation of essential documents as required /liliProvide regulatory/SSU strategic input to internal and external customers. Develop theregulatory strategy and the SSU Plan, joint operating procedures and core documents /liliPromptly identify and escape potential risk to the project team which may jeopardisedeliverables; support corrective/preventive actions /liliPerforms other work-related duties as assigned. /li /ululliGraduate degree in Chemistry or Life Sciences, Nursing or equivalent combination of education and experience /liliMinimum 4 years within pharmaceutical or CRO industry orRegulatory body /liliGood knowledge of ICH GCP and national regulations for territories of competency /liliGood understanding of specific country requirementspertaining to SSU/Regulatory delivery in multiple countrieswithin Europe and/or the Americas /li /ulpWhen you joinErgomedGroup, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world.You’lljoin a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting. /ppWe are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here. /pulliQuality:we hold ourselves to the standard patients deserve. /liliIntegrity and trust:we do the right thing, especially when it is hard. /liliDrive and passion:we care about theoutcome, becausesomeone is waitingonit. /liliAgility and responsiveness:we movequickly, becausepatients cannot wait. /liliBelonging:everyone is welcome, and every voice counts. /liliCollaborative partnerships:we go further by going together. /li /ulpWe look forward to welcoming your application. /p /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7kqrno