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Clinical Medical Writer

hace 1 mes

Barcelona, España Asphalion A tiempo completo

Asphalion is growing and we are looking for a Scientific Clinical Writer to join our team of development, strategy and scientific writing expert unit in the pharmaceutical industry Someone who loves to take new challenges, to work in an international environment and who wants to grow with us

**Main responsibilities**:
As a Medical Writer you will be in charge of the timely and correct execution of projects according to defined timelines:

- Being in charge of the roadmap design of clinical plans and leading its correct planning, execution of tasks, timelines and project reporting.
- Writing of the eCTD Dossier clinical documents.
- Writing regulatory documents to support drug development (SA, PIP, ODD, IMPD ,IB)
- Creation of the regulatory strategy for MAA
- Direct interaction negotiating with Regulatory Authorities (EMA, FDA, TGA)
- Direct contact with clients and interaction with multidisciplinary teams across the company, optimizing projects and development programs.

**Requirements**:

- Scientific biomedical background: phD, Post-Doctoral
- +7 years experience in pharma sector or biotech
- Project management skills and experience leading clinical development plans
- Experience leading & managing teams
- Proactive, Good communication, client oriented
- Fluent English & Spanish
- Advanced IT Level (MS Office)
- Experience in drug development.

**We Offer You**:

- A highly, dynamic & international working environment with employees from more than 15 nationalities.
- 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.
- Training and personal development program.
- Flexible working schedule - Compacted workday on Friday.
- Social Benefits: English lessons, wellbeing programme, flexible remuneration.
- Home Office - Hybrid or Remote Model **(You can be located anywhere in Spain)**:

- Permanent contract