Medical Writer
hace 1 semana
**Purpose of the role**:
We are looking for a Medical Writer - Drug development specialist for our team of scientific writing expert unit. Someone who loves ATMPs & Science and wants to use their experience in a new challenging professional step.
**Tasks & Responsibilities**:
The Medical Writer will be in charge of the timely and correct execution of ATMPs projects according to defined timelines:
- Design of roadmaps ATMPs Projects
- Design a path of tasks to achieve milestones and objectives
- Manage of client and partner ATMPs projects: partnership agreements, locate clients, plan tasks of clients, manage timelines, clinical trials, etc
- Writing regulatory documents (SA, PIP, eCTD Dossier) of ATMPs projects.
- Writing founding memories requests. Write proposals for European projects (HZ)
- Negotiation with CROs, contracts, etc
- Liaison with health authorities for drug development procedures.
- Management of funding meetings with investment groups
According the project all activities can be done for gene therapies, cell therapies..., ATMPs products and medical devices.
**Requirements**:
- +2 year experience working in pharma sector, biotech or spin-off /start u
- +1 year experience in Project Managemen
- Regulatory Affairs Knowledg
- Scientific background : PhD, Post-Doctora
- Proactive, good communication, accurate, detail orientated
- Fluent in English & Spanis
- Advanced IT level - (MS Office)
**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.
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