Study Start Up and Regulatory Affairs Specialist

🕒 il y a 1 jour

🇪🇸 Espagne – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

🚔 Conformité

👻 Score fantôme 18%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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ERGOMED

Site WebLinkedInTous les Emplois

1001 - 5000 employés

Fondée en 1997

💼 Conseil

🏥 Santé

📦 Logistique

Consulting • Healthcare • Logistics

ERGOMED est un groupe international qui fournit des services spécialisés aux industries biotechnologique et pharmaceutique. Il opère à travers plusieurs lignes de services, notamment Ergomed Clinical Research, PrimeVigilance et ADAMAS Consulting, et se consacre à offrir des capacités complètes de CRO (Contract Research Organization). Axé sur l’oncologie, les maladies rares et les essais complexes, il propose également des services de pharmacovigilance et d’information médicale de bout en bout, ainsi que des audits GxP complets. Ergomed s’engage à accompagner le développement de médicaments, avec une présence mondiale dans une centaine de pays environ.

Description

• Lead and coordinate activities required to achieve site initiation readiness • Provide subject matter expertise on study start-up and regulatory affairs • Ensure regulatory compliance and liaise with internal teams, clients, and external stakeholders • Deliver assigned study start-up and regulatory milestones within defined scope • Make independent decisions regarding regulatory processes and documentation approaches • Handle medium-complexity regulatory environments, including multi-country requirements where applicable • Lead study start-up and regulatory activities for assigned countries or projects in line with timelines, quality standards, and regulatory requirements • Prepare, review, and quality-control regulatory and study start-up documentation, including submissions, essential documents, and translations • Draft, negotiate, finalize, and execute clinical site agreements, ancillary agreements, and amendments • Review labels, patient information sheets, diary cards, insurance documents, and other relevant documentation • Provide regulatory and study start-up strategic input to internal and external customers • Develop regulatory strategies, study start-up plans, joint operating procedures, and core documents • Identify and escalate risks that may jeopardize project deliverables and support corrective/preventive actions • Perform other work-related duties as assigned

🎯 Exigences

• Graduate degree in Chemistry or Life Sciences, Nursing, or equivalent combination of education and experience • Previous experience within the pharmaceutical or CRO industry or a regulatory body • Good knowledge of ICH GCP and national regulations for territories of competency • Good understanding of country-specific requirements for study start-up and regulatory delivery in multiple countries within Europe and/or the Americas • Ability to lead study start-up and regulatory activities for countries or projects of medium complexity • Ability to prepare, review, and quality-control regulatory and study start-up documentation • Ability to draft, negotiate, finalize, and execute clinical site agreements, ancillary agreements, and amendments • Knowledge of regulatory and clinical documentation, including labels, patient information sheets, diary cards, and insurance documentation • Ability to contribute to complex technical, scientific, and legal documentation • Ability to arrange and/or review translations of essential documents • Ability to develop regulatory strategies, study start-up plans, joint operating procedures, and core documents • Ability to identify and escalate project risks and support corrective/preventive actions

🏖️ Avantages

• Remote work option • Work-life balance • Collaborative international team • Career growth opportunities • Ownership and autonomy early in career • Opportunity to work on meaningful clinical research supporting safe and effective pharmaceutical treatments • Collaborative and supportive work environment