Medical Writer R&D Pharma industry

Asphalion
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Descripción

Asphalion is an International Scientific and Regulatory Affairs consultancy, with offices in Barcelona, Madrid Londres and Munich.

We offer comprehensive services for Drug Development and Regulatory Affairs to Pharma, Biotech and Medical Devices companies. Since 2000, we have consistently grown and now have over 110 professional consultants with backgrounds in Life sciences (Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, Medicine and Veterinary Medicine). Our consultants are experts in their field and are in direct contact with EU agencies (EMA and NCAs) for the development and implementation of new regulatory standards.

Asphalion provides a global range of services, for global clients. Our services range from early development, throughout the registration, until marketing and post-commercialization phases

of your product. Through our network of regulatory consultants, Asphalion is in a position to support your worldwide scientific & regulatory activities. We make use of a dedicated US agent in the fields of Pharma/Biotech, Medical Devices and In Vitro Diagnostics.

Purpose of the role

We are looking for a Medical Writer 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.

Functions/Key Activities

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.

Profile:

  • +1 year experience working in pharma sector, biotech or spin-off /start up
  • +1 year experience in Project ManagementScientific background : PhD, Post-Doctoral
  • Proactive, good communication, accurate, detail orientated.
  • Fluent in English & Spanish
  • Advanced IT level – (MS Office)

We offer you: 

  • A highly professional, dynamic, ambitious & international 
  • working environment
  • An organization with highly professional people to develop with More than 12 nationalities!
  • Training and personal development program
  • A great company culture built around Passion, Flexibility, 
  • Commitment, Quality & Companionship
  • Home Office / You can be located in BCN or Madrid.
  • Flexible working schedule. We enjoy Friday afternoon
  • Social Benefits: English lessons/ Flexible remuneration
  • Permanent contract