Regulatory/Clinical Development Specialist. Zürich
Trabajos en Zürich (Suiza) de Farmacéuticos
Clasificación del trabajo:Profesionales científicos e intelectuales : Profesionales de la salud : Otros profesionales de la salud : Farmacéuticos. Akademische Berufe : Akademische und verwandte Gesundheitsberufe : Sonstige akademische und verwandte Gesundheitsberufe : Apotheker.
Descripción de la oferta de trabajo:
We are looking for a full-time regulatory/clinical specialist with experience in defining clinical development strategies as well as hands-on management of all technical and operational aspects related to the regulatory filings prescribed by the European agencies. ssential duties and responsibilities • Work closely with the senior executive team in a collaborative and welcoming environment. • Be actively involved in CRO selection and management. • Design clinical development plans and individual clinical trials (single and multi-centered). • Author, assemble, and/or review study documents (e.g., clinical trial protocols, Investigator Brochures, and clinical study reports), and regulatory submissions (e.g., Briefing Documents for advice meetings, orphan drug designation, IMPD, CTA, IND); maintain these applications as required. • Manage clinical trials from start up to close out: monitoring visits, recruitment and enrolment of patients, covering informed consent, eligibility and compliance with the protocol, study drug accountability, protocol deviations. • Support data management: queries generation and resolution, adverse events, track and follow-up on serious adverse events, eCRF review, eTMF, maintenance of Study Files... • Interact with FDA, EMA and other agencies (e.g., document preparation, coordination of meeting rehearsals and minutes…) and communicate with Ethics Committees. • Implement SOPs to assure quality of preclinical and clinical related activities. • Review all QC/QA relevant issues and support internal and external audits. Experience, knowhow, and desired characteristics • MS or higher degree in Life Sciences with at least 5 years of experience in regulatory affairs and clinical trial operations. • Hands-on experience in preparation, submission and lifecycle management of Briefing Packages, ODD, and CTA/IND and amendments. • In depth knowledge of ICH guidelines and GCP, GLP regulations. • Solution-driven person with strong initiative and drive. Must be an organized, rigorous self-starter who is able to anticipate the company’s needs. • Able to define its own workflow and execute it independently, while handling multiple priorities.
Servicio de empleo de origen:SECO, Servicios Públicos de Empleo, Suiza.