BioNTech SE
Director Scientific / Medical Writing(m/w/x)
Vollzeit
Senior
Keine Angabe
Mainz
AB
AbbVie11 Tage
Strategic Medical Writer(m/w/x)
Vollzeit
Berufserfahren
Keine Angabe
Wiesbaden
Nejo KI-Zusammenfassung
In this role, you will support the JCA core team by preparing high-quality EUHTA documents and ensuring compliance with regulations. Your daily responsibilities will include writing, coordinating reviews, and resolving issues to meet project timelines.
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Anforderungen
- •Minimum of 3 years of bio-pharmaceutical industry experience
- •Extensive experience in writing HTA dossiers
- •Bachelor's Degree or higher in a scientific discipline
- •Outstanding written and oral communication skills
- •Proficiency in assimilating and analyzing complex data
- •Advanced understanding of HTA dossiers and requirements
- •Excellent English writing skills
- •Ability to collaborate with cross-functional teams
- •Strong organizational, time management, and problem-solving skills
Bachelor-Abschluss
Berufserfahrung
3 Jahre
Deine Aufgaben
- •Provide clinical EUHTA document support to the JCA core team
- •Prepare high-quality submission-ready documents
- •Implement the clinical writing process effectively
- •Write less complex document types with minimal supervision
- •Seek close supervision for more complex document types
- •Communicate document deliverables, writing process, and timelines to team members
- •Hold team members accountable for project deadlines
- •Identify and propose solutions to issues during the writing process
- •Elevate issues as appropriate
- •Comply with conventions, grammar usage, and format requirements per EU HTA regulations
- •Arrange and conduct review meetings with the team
- •Act as an interface to resolve writing process issues
- •Collaborate with the manager during the document audit process
- •Draft responses with the JCA Core team and manager
- •Focus on quality and compliance while ensuring timely delivery
- •Maintain familiarity with HTA dossier regulations and guidance
Sprachen
Englisch – verhandlungssicher
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