BioNTech SE
Director Manufacturing Sciences & Technology(m/w/x)
Vollzeit
Senior
Keine Angabe
Mainz
BI
BioNTech SE2 Monate
Director Scientific / Medical Writing(m/w/x)
Vollzeit
Senior
Keine Angabe
Mainz
Nejo KI-Zusammenfassung
In this role, you will lead the creation of high-quality scientific documents while managing a dynamic team. Your day-to-day responsibilities will include writing, coordinating, and ensuring compliance with regulatory standards, all while fostering a collaborative environment that adds value to the organization.
Lass KI die perfekten Jobs für dich finden!
Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.
Anforderungen
- •Relevant life science university degree, ideally M.D., Pharm. D, or Ph.D.
- •>10 years hands-on experience in drug development in a therapeutically relevant field, preferably in oncology and/or immunology
- •>10 years hands-on experience as a scientific or medical writer in the pharmaceutical/biotech industry
- •Prior experience drafting documents for multiple indications, preferably in BioNTech-relevant indications
- •Prior experience drafting new or updated CTPs and CSRs required for Phase I-III trials
- •Prior experience drafting high complexity variants of IBs, clinical CTD-CTA-IMPD/IND modules, clinical CTD-BLA/MAA modules
- •Prior experience as lead medical writer for BLA/MAA dossiers, ideally for BioNTech-relevant indications
- •Prior experience managing small teams of writers supporting the drafting of BLAs/MAAs dossiers
- •Prior experience drafting new or updated variants of DSURs/Annual Reports, RMPs, RFI Response documents, Diversity Plans, PIPs/PSPs, and other CTD Module 1 documents
- •Prior experience editing/reviewing R&D reports
- •Prior experience drafting low to high complexity variants of R&D reports
- •Prior experience as a line manager/with line management tasks
- •Knowledge of basic business acumen (planning, operations, finance, and strategy)
- •Knowledge of budget, resource, and project management
- •Can do attitude with ability to work according to tight timelines and prioritize workload
- •Advanced interpersonal skills
- •Advanced motivation, coordination, and conflict resolution skills
- •Expert MS Word skills
- •Good MS PowerPoint & Excel skills
- •Good Adobe Acrobat Pro skills
- •Good MS TEAMs / SharePoint skills
- •Advanced DMS author user skills
- •Advanced knowledge of relevant regulations/guidance on regulatory documents
- •Advanced knowledge of drug development process and needs of relevant stakeholders
- •Advanced knowledge of statistics, trial design, data reporting, and relevant experimental models
- •Advanced knowledge of outcome measures used in trials for immunotherapeutic agents
- •Good knowledge of good publication practices
Master-Abschluss
ODER
Doktor / Ph.D.
Berufserfahrung
10 Jahre
Deine Aufgaben
- •Write, edit, and format scientific documents of varying complexity
- •Coordinate document preparation, review, and approval
- •Check and revise documents for scientific content and compliance
- •Manage outsourced medical writing tasks and external writers
- •Coordinate teams preparing dossiers for marketing approval
- •Support and guide compliance with relevant processes and standards
- •Train and guide on good writing practices and document formatting
- •Ensure compliance with international pharmaceutical regulations
- •Stay updated on applicable guidelines and regulations
- •Implement role-relevant tools, guidelines, and training materials
- •Identify and drive process optimizations with internal partners
- •Create and implement standards and processes as needed
- •Interact with regulatory authorities for timely responses
- •Perform complex medical writing tasks independently
- •Serve as subject matter expert for assigned topics
- •Define strategies and standards for medical writing activities
- •Build and maintain a cohesive, innovative team
- •Recruit, supervise, and mentor team members
- •Set objectives and provide performance assessments
- •Ensure fair task assignments and timely training completion
- •Promote a positive and productive team attitude
- •Plan unit FTE and support department budget development
- •Act as deputy to the department head
Tools & Technologien
MS WordMS PowerPointMS ExcelAdobe Acrobat ProMS TEAMsSharePointDMS
Sprachen
Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BioNTech SE erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Ähnliche Jobs direkt in deine Inbox?
Noch nicht perfekt?