Senior Medical Writer (gn)

Stellenbeschreibung

MorphoSys's mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines. We all are driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the MorphoSys team is given the opportunity to develop and flourish within this exciting and inspiring environment. Join us in Planegg near Munich!

As a Senior Medical Writer (gn) you are responsible for the planning and generation of clinical and regulatory documents and related tasks for MorphoSys. You will work within Clinical Development Organization (CDO) to develop clinical and regulatory documents that are compulsory to fulfill regulatory requirements. In this position, you will make a decisive contribution that MorphoSys will become a fully integrated pharma company.

Your Responsibilities:

  • Developing documents for regulatory purposes such as IND, Investigator's Brochure, DSUR, PSUR, Briefing Books for health Authority interactions
  • Developing clinical documents such as Clinical Study Reports (CSRs)
  • Coordinating the team contributing to the above mentioned documents, schedule and lead initiation and adjudication meetings
  • Gathering, evaluating, organizing, managing and collating information in a variety of formats
  • Ensuring compliance with regulations set by the regulatory authorities (primarily FDA and EMA as well as European National Agencies)
  • Keeping up to date with changes in regulatory legislation and guidelines
  • Analysing complicated information, including trial data
  • Providing advice about regulations to manufacturers / scientists
  • Ensuring that quality standards are met and submissions meet strict deadlines
  • Preparing documentation

Your Requirements:

  • Relevant degree, such as life science, medicine, biology, chemistry, physics, biochemistry, biotechnology, pharmacy, medicinal chemistry
  • Previous employment in life sciences in a position as Regulatory or Medical Writer (gn) (3-5 years)
  • Relevant postgraduate qualification (PhD or research-based MSc) would be advantageous
  • Excellent writing and speaking skills in English are compulsatory, native English speaker preferred
  • Knowledge about requirements of document content and formatting
  • Good and fast understanding of biological and clinical complex situations
  • Ideally health authority and pharma experience
  • Understanding of complex, policy - driven health care topics
  • Certification from a Writer's association
  • Keen attention to detail and strong organization skills
  • Leadership skills to drive teams forward

We offer:

  • Creative working in X-functional teams
  • Open and appreciative corporate culture
  • Multicultural environment
  • Working in an attractive, high-quality equipped building with restaurant
  • Free sports and language courses
Thank you for your interest! We are looking forward to receiving your pertinent application documents. For your application please use exclusively our career portal. We offer not only excellent career prospects, but also support you from the very beginning - even helping you move if neccessary.

MorphoSys AG, Semmelweisstraße 7, 82152 Planegg
Direkt zur Stelle