Medical Writer (m/f/n) – Freelance – on hold

  • Position zu besetzen ab 3. Oktober 2021
  • Permanent-ID OCR-FL-1455
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 6x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

Description
• Processing of safety-related documents (e.g., DSURs, PBRERs, Risk Management Plans, Signal Evaluation Reports, Benefit-Risk Strategy Documents)
• Processing of the safety strategy related to these documents and to regulatory submissions

Qualifications:
• >5 years experience as Medical Writer with knowledge in safety related documents (e.g. DSURs, PBRERs, Risk Management Plans, Signal Evaluation Reports, Benefit-Risk Strategy Documents)
• Thorough understanding of the safety strategy related to these documents and to regulatory submissions
• Ability to coordinate vendor resources and to track timelines and priorities of documents together with safety project management
• Strong communication skills with the ability to interpret and summarize complex data
• Technical expertise in Microsoft Office suite, MW Word templates, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management
• Ability to maintain familiarity with current industry practices, regulatory requirements, and guidelines that affect Medical Writing.
• Strong organizational skills
• Strong presentation skills and adapting to a variety of audiences
• Fluent in English (oral and written)

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