Medical Writer - Immediate Start - Munich, Germany

Munich  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Description

Medical Writer - Immediate Start - Munich, Germany

As a Senior Medical Writer (gn) you are responsible for the planning and generation of clinical and regulatory documents and related tasks. 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 will become a fully integrated pharma company.

Ihre Verantwortungsbereiche:
  • 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


Sie bringen idealerweise folgende Voraussetzungen mit:
  • 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 (3-5 years)
  • Relevant postgraduate qualification (PhD or research-based MSc) would be advantageous
  • Excellent writing and speaking skills in English, 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
Start date
10/2019
Duration
12 Months
From
Optimus Search GmbH
Published at
02.10.2019
Project ID:
1830471
Contract type
Freelance
To apply to this project you must log in.
Register