Medical Writer Specialist

vor 5 Stunden

Böblingen, Baden-Württemberg, Deutschland Wörwag Pharma Vollzeit
Join Our Team as a Specialist Medical Writer

We are seeking a highly skilled Specialist Medical Writer to join our team at Wörwag Pharma. As a Specialist Medical Writer, you will be responsible for preparing parts of eCTD dossiers relevant for marketing authorizations in accordance with regulatory and internal specifications for European and global marketing authorization.

Key Responsibilities:
  • Collaborate with cross-functional teams to prepare high-quality medical writing content for regulatory submissions.
  • Review and evaluate the accuracy, consistency, and plausibility of externally produced clinical and non-clinical documents relevant for marketing authorization.
  • Develop and maintain a deep understanding of regulatory requirements and guidelines for medical writing.
  • Work closely with Regulatory Affairs and Global Pharmacovigilance teams to address medical/scientific issues.
  • Ensure compliance with internal deadlines and quality specifications for medical writing processes.
Requirements:
  • Successful completion of scientific studies or a comparable scientific education (e.g., Master, Pharmaceutical sciences, Medical sciences, Engineering level).
  • Several years of professional experience in Medical Affairs (Medical Writing) and/or Regulatory Affairs/Regulatory Medical Writing is a plus.
  • Pronounced ability to produce written documents of high quality and check the technical content of externally produced documents.
  • Excellent communication and assertiveness skills, with German as a native language or the equivalent of a C1 level, and a very good command of English.
What We Offer:
  • A dynamic, international environment with opportunities for professional growth and development.
  • Variety of challenges and exciting projects with a strong team spirit.
  • Competitive compensation and benefits package, including flexible working hours and mobile work options.
  • Opportunities for personal and professional development, including training and education programs.
  • A wide range of employee benefits, including health-promoting measures and regular employee events.

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