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:
- Educational 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.
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