Medical Writing/Health Technology Assessment (HTA) Manager

Reference Number: 895777-W
Type of placement: Permanent
Location: Germany

Introduction:

In this role you will act as a Medical Writing /Health Technology Assessment Manager within the core team and make an active contribution to dossiers for new pharmaceutical products of the company.

Main Responsibilities:

  • Preparation of HTA (AMNOG) Dossiers for early benefit assessment in the German health care system. Best possible preparation of presentation of clinical, regulatory and epidemiological data according legal and HTA framework (incl. advice requests)
  • Part of the dossier core team in integrated partner in developing best possible dossier strategy
  • Analysis of clinical data, -reports and publications
  • Intensive interaction with internal and external statisticians to request data analyses according IQWiG methodology and G-BA framework for early benefit assessment („Payer perspective“)
  • Develop knowledge about company’s Lifecycle  pipeline products and indications
  • Shaping dossier preparation based on developments in changing methodology and shared learning, experience. Transfer knowledge into team
  • Close cooperation with external agencies for dossier preparation

Qualifications and Experience:

  • Degree in science, medicine, health economy, pharmacy or equivalent
  • Minimum of 2 - 5 years working experience as Medical Writer
  • Expertise in medical writing of regulatory documents/clinical overview or equivalents or in HTA (AMNOG) dossier preparation
  • Excellent knowledge of drug development, clinical studies, study design, pharmacology, risk/benefit assessment
  • Excellent time and priority management; experience in project management appreciated
  • Conscientious and detailed work
  • Quick comprehension
  • Team player and solution-oriented with ability to represent own positions
  • Pleasure working self-responsible and with an eye-to-eye level (equal footing) working style
  • Ability to work under pressure
  • Very good computer skills - MS-Office
  • Confident handling in managing references via software program (e.g. Endnote) appreciated
  • Excellent written and verbal communication skills in German; Fluent in English

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