Senior Medical Writer (m/f/d)

Senior Medical Writer (m/f/d)

Senior Medical Writer (m/f/d)

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HealthCorp Partners GmbH

Ludwigstraße 8 (Ludwigpalais)

80539 München


Ihre Ansprechpartnerin:

Karin Nissen

+49 89 8906340-27

karin.nissen@healthcorppartners.com

Senior Medical Writer (m/f/d)

Pharma ∙  Southern Germany  ∙  Referenz-No. 19452

The Company

Our client is a biopharmaceutical company.

Essential Duties & 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

Candidate Profile

Education and Experience

  • 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
  • Knowledge about requirements of document content and formatting
  • Ideally health authority and pharma experience
  • Certification from a Writer’s association

 

Functional / Specific Competencies

  • Good and fast understanding of biological and clinical complex situations
  • Understanding of complex, policy – driven health care topics
  • Keen attention to detail and strong organization skills
  • Leadership skills to drive teams forward
  • Excellent writing and speaking skills in English, native English speaker preferred