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Medical Writer Expert – Regulatory Affairs
ASPHALIONalmería, EspañaHace 13 días
Descripción del trabajoEducational Background : Scientific / biomedical background Experience : Minimum of 8-10 years in a similar role working in regulatory writing in pharma sector, or spin-off / start up Skills and Competencies : Strong knowledge of regulatory affairs. Excellent client-oriented communication skills and proactive mindset. Advanced proficiency in IT tools (MS Office Suite). Languages : Fluency in English (C1 or higher) is mandatory; Spanish is a significant advantage.
We are looking for a Medical Writer Expert– Regulatory Affairs for our team of development, strategy and scientific writing expert unit. Someone who loves Science and wants to use their experience in a new challenging professional step.
Main responsibilities :
The Medical Writer will be in charge of the timely and correct execution of projects according to defined timelines :
- Writing regulatory documents to support drug development (SA, PIP, ODD, IMPD ,IB )
- Writing eCTD Dossier clinical / nonclinical documents (M2)
- Design of regulatory roadmaps
- Regulatory strategy for MAA
- Client and partner management : define milestones, planning and execution of tasks, manage timelines, project reporting
- Liaison with health authorities for drug development procedures
- Submission and management of applications through portals (CTIS, IRIS, ...)
Requirements :
Why working at Asphalion?
Permanent contract.
Flexible working schedule - Friday until 15.30h.
Homeoffice & Hybrid or Remote Model (You can be located anywhere in Spain!)
Wide variety of projects, new challenges and experiences.
Training and personal development program.
English lessons.
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Medical Writer • almería, España