Sobi - Swedish Orphan Biovitrum AB (publ)
rare strength
orphan drugs • hereditary metabolic disorders • haemophilia • biopharmaceuticals • patient access
1001 - 5000
Principal Medical Writer
September 23
🇺🇸 United States – Remote
⏰ Full Time
🔴 Expert
✏️ Content Writer
Sobi - Swedish Orphan Biovitrum AB (publ)
rare strength
orphan drugs • hereditary metabolic disorders • haemophilia • biopharmaceuticals • patient access
1001 - 5000
Description
• Provide expert leadership, strategic thinking and communication skills • Prepare clinical regulatory documents throughout drug development, post-marketing, and life-cycle management • Lead authoring of clinical components of regulatory submissions • Liaise with senior project staff • Assume a Product Medical Writer responsibility • Coach and develop less experienced Medical Writers • Oversee and coordinate all Medical Writers
Requirements
• Life Science Master’s degree or PhD • Minimum 8-10 years' regulatory medical writing experience • In-depth knowledge of regulatory medical writing processes • Experience in leading complex global regulatory and clinical writing projects • Clear understanding of clinical development • Advanced knowledge of global regulatory environment and processes • Excellent written and spoken English skills • Strong analytical and strategic thinking • Strong interpersonal, communication, and influencing skills • Ability to manage multiple parallel tasks • Highly developed respect for timelines • Attention to detail
Benefits
• Competitive benefits package • Opportunity to work at an international pharmaceutical company
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