Requirements: English
Company: ASPHALION
Region: Pamplona , Navarre
We are looking for a
Medical Writer Regulatory Affairs Senior officer
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:Educational Background: Scientific/biomedical backgroundExperience: Minimum of 3 years in a similar role working in regulatory writing in pharma sector, or spin-off /start upSkills 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.
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.A professional, inclusive and high-performance work environment to develop your skills and grow your career. A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship.A highly & dynamic working environment with employees from more than 15 nationalities.Our people and their well-being are our priority: Physical, psychological and emotional well-being programme.Internal activities & RSC Activities Equal Opportunity Employer