MEDICAL WRITER & CLINICAL DEVELOPMENT MANAGER (M/F/D)
PHARMA

Our client is a European pioneer in the development, marketing and distribution of medicines for people with rare and complex diseases. To enhance the Clinical Development team at the Vienna headquarters our client is looking for a Medical Writer & Clinical Development Manager (m/f/d).


Responsibilities

  • Developing the design, synopsis, protocol, amendments and final reports for clinical studies
  • Supporting regulatory interactions addressing questions and responses
  • Preparing and contributing to scientific documents (e.g., safety annual reports, clinical trials, and submission documents)
  • Involvement in the identification of potential investigational sites and providing support during trial conduct
  • Presenting clinical data internally and externally (incl. publications)
  • Maintaining awareness of new developments within the company´s core therapeutic areas building upon own expertise through attendance at congresses, seminars, and meetings
  • Offering medical/scientific advice and training to company’s personnel as needed
  • Working closely with stakeholders including Department Heads, CSO and CMO
  • Participating in multidisciplinary project teams and working with other functions in the assessment of new in-licensing opportunities


Professional Skills

  • Natural science/scientific background (FH, university)
  • Experienced in medical writing of clinical documents (clinical study protocols, clinical study reports, publications, clinical sections of dossiers, and regulatory documents)
  • Experienced in clinical development, ideally in designing clinical studies, biostatistics, interpretation of clinical data
  • GCP knowledge
  • Strong communication and presentation skills in English and German
  • IT skills (Office 365, Adobe Acrobat, alternatively MS-Project)
  • Enjoying to work in a growing international company introducing solutions for rare diseases to new markets
  • Preferring a high degree of independence and responsibility for assigned projects
  • Being able to manage multiple projects, to prioritize and self-manage


The gross yearly salary provided for this function is a minimum of EUR 75,000 (excluding bonus) based on a full-time employment. Any potential overpayment depends on professional experience and qualifications.


We are looking forward to receiving your application addressed to Katrin Spögler, BA, MA quoting reference number E1131 to jobs2@eblinger.at