Senior Medical Writer

Région
Liège (Ville) (BE)
Publication
mercredi 9 août 2017
Date limite
samedi 9 septembre 2017
Niveau d'expérience
5 à 10 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein

ASIT biotech is a Belgian clinical stage biopharmaceutical company focused on the development and future commercialisation of a range of breakthrough immunotherapy products for the treatment of allergies. Thanks to its innovative ASIT+TM technology platform, ASIT biotech is currently the only developer of AIT product candidates consisting of a unique mixture of highly purified natural allergen fragments in an optimal size selection. This innovation results in a short treatment, expected to improve patient compliance and real-life effectiveness. ASIT biotech’s product pipeline entails two novel ASIT+™ product candidates targeting respiratory allergy with the highest prevalence (i.e. grass pollen: gp-ASIT+TM and house dust mite: hdm-ASIT+TM), that could significantly expand the current immunotherapy market. The Company believes that its innovative ASIT+™ platform is flexible and would be applicable across a range of allergies.

ASIT biotech has a headcount of 25 staff members, located at its headquarters in Brussels and laboratory in Liège, Belgium.  

Job Purpose

The Senior Medical Writer is responsible for the preparation and coordination of a wide range of clinical and regulatory documents, including Investigator Brochures, Clinical Study Reports, Clinical Trial Protocols, Clinical Summaries of Efficacy and Safety and Clinical Overviews. The documents must be of high quality in terms of scientific content, organization, clarity, accuracy, format and consistency, and must adhere to regulatory guidelines and company styles and processes.

Reports directly to the Head of Medical & Scientific Affairs.

Key Responsibilities

  • Coordinating, in the first place, our CRO partners with respect to their writing activities;
  • Being the first point of contact for internal parties who seek to staff their requirements for writing activities;
  • Defining and fine-tuning internal processes and standards;
  • Writing press releases;
  • Keep website up to date;
  • Introduction and follow-up of subsidized projects;
  • Participation in project-and study-teams and providing support when it’s requested.

 Qualifications

  • Master's degree in a scientific discipline (biological or medical sciences);
  • Strong scientific/medical writing skills including the ability to interpret and organize scientific data;
  • Escellent written and verbal language skills in English & French;
  • Experience in medical writing or relevant pharmaceutical/CRO related experience with working knowledge of clinical research and biostatistics;
  • Committed to delivering excellence, pro-active, a strong team focus;
  • Proficiency in computer word processing programs;
  • Stong interpersonal and communication skills as the individual must be able to work in a team environment and coordinate with the team to move documents forward to completion

We offer

  • To join a company with a very high growth potential,
  • To integrate a very competent and motivated team,
  • To collaborate to the development of innovative products in a very dynamic environment,
  • Attractive salary and benefit package.