Clinical Trial Disclosure Lead
16 hours ago
This position plays a critical role in executing global and national clinical trial disclosure requirements across Genmab's entire portfolio.
Key Responsibilities:- Manage Public Disclosure: Oversee the public disclosure of clinical trial protocols, results, and document redaction.
- Develop Timelines: Create and maintain timelines for protocol registration and results disclosure on platforms like ClinicalTrials.gov and EU CTIS.
- Author Plain Language Summaries: Develop or oversee the creation of plain language results summaries.
- SOP Development: Develop and update Standard Operating Procedures (SOPs), templates, and oversee applicable system implementations to ensure efficiency and compliance.
- Training and Compliance: Train internal staff and vendors on disclosure processes to ensure regulatory compliance.
- Landscape Monitoring: Monitor the external landscape to ensure Genmab's adherence to relevant industry guidelines.
- Experience: Previous experience with clinical trial disclosure is essential.
- Educational Background: A Bachelor's degree is the minimum requirement.
- Industry Knowledge: 1-3+ years of pharmaceutical industry experience with a good understanding of clinical development.
- Communication Skills: Excellent written and verbal communication skills are required.
- Passion: You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.
- Rigor and Excellence: You bring rigor and excellence to all that you do, believing in our rooted-in-science approach to problem-solving.
- Collaboration: You are a generous collaborator who can work in teams with diverse backgrounds.
- Innovation: You are not afraid to grapple with the unknown and be innovative.
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Data Disclosure Specialist
16 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob DescriptionWe are seeking an experienced Data Disclosure Specialist to join our Clinical Trial Disclosure & Transparency team at Genmab. As a key member of this team, you will be responsible for ensuring the accurate and timely disclosure of clinical trial information in accordance with global and national regulations.About UsGenmab is a biotechnology...
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Clinical Trials Coordinator
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Clinical Development Strategist
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Regulatory Affairs Project Lead
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Regulatory Expert
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Copenhagen, Copenhagen, Denmark Københavns Universitet Full timeAbout UsKøbenhavns Universitet is a leading research institution in the field of veterinary clinical pathology. Our department is recognized for its strong and internationally renowned research areas, covering a broad spectrum of topics within animal health and disease.We are committed to advancing knowledge and innovation through cross-disciplinary...
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Global Regulatory Affairs Project Manager
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Transformational Process Development Lead
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Lead Regulatory Affairs Strategist
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Senior Medical Director for Nordic Countries
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Lead Quality Systems Specialist
1 day ago
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Senior Technical Development Manager
16 hours ago
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Copenhagen, Copenhagen, Denmark Rigshospitalet Full timeArbejdspladsenNordisk Selskab for Gynækologisk Onkologi - Clinical Trial Unit (NSGO-CTU) søger en engageret projektmedarbejder til vores fantastiske team af kollegaer på CTU-kontoret. Stillingen er til besættelse snarest muligt, og gerne 1. oktober eller 1. november.FunktionssammenhængProjektmedarbejder vil være ansvarlig for koordinering af...
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Copenhagen, Copenhagen, Denmark Genmab AS Full timeAt Genmab, we're dedicated to pioneering transformative technologies that empower patient care. Our innovative approach involves developing cutting-edge solutions that optimize GxP workflows across our extensive portfolio of research and clinical development platforms.About the RoleWe seek a skilled Senior Quality Engineering Architect to drive the...