We are looking for a
Medical Writer – ATMPs Expert
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 related to ATMPs according to defined timelines:
- Writing regulatory documents to support drug development (SA, PIP, ODD, IMPD ,IB )
- Ad hoc regulatory consultancy or drug development
- Design of nonclinical development plans for biological/ATMP products
- Writing eCTD Dossier clinical/nonclinical documents
- Client and partner management: define milestones, planning and execution of tasks, manage timelines, project reporting
- Liaison with health authorities for drug development procedures
- Design of clinical trial protocols and literature reviews
- Consult on the regulation and documentation of trials with advanced therapy medicinal products

Requirements

Educational Background: Scientific/biomedical background (PhD or Post-Doctoral preferred).





Experience: Minimum of 3 years in a similar consultancy role, with proven expertise in regulatory writing, nonclinical and clinical development plans, or related areas in ATMPs and/or biologic development projects

Experience in the pharma or biotech sectors is a strong plus.

Skills and Competencies:

Strong knowledge of project management, regulatory affairs, and drug development processes.

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.

? Versátil 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

📌 Medical Writer (España)
🏢 Asphalion
📍 España