ZEISS sucht in eine/n Senior Expert Regulatory Affairs (m/f/x) (ID-Nummer: 13400051)
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INCI-Listen und Auslobungen Bearbeitung unerwünschter Wirkungen (Kosmetovigilanz) in Zusammenarbeit mit medizinisch-wissenschaftlichen Funktionen Vervollständigung und Pflege von Rohstoff- und Verpackungsdokumentationen Schnittstellenarbeit mit internen Abteilungen, externen Experten und Behörden Bewertung von Rohstoffen anhand bereitgestellter Dokumente Bearbeitung von Kundenanfragen, z.B. zu Allergenen Abgeschlossenes Studium der Pharmazie, Lebensmittelwissenschaften, Biologie oder vergleichbare Qualifikation Fundierte Kenntnisse der kosmetischen Regularien (EU sowie internationale Anforderungen) Sehr gute Vertrautheit mit Rohstoffen, INCI-Deklarationen und Sicherheitsbewertungen Erfahrung im Qualitätsmanagement und in der Dokumentation (z.B.
Key Responsibilities: Leadership: Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company Represent sponsors at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee Participate in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication Participate as high level lead biostatistician on major projects, including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries and/or NDA sections Leading studies at an operational level Provide expert review and initiate methodology development work with regards to statistical standards and validation procedures Consult on operational/statistical/therapeutic area topics Knowledge Sharing: Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact on analyses Performs as subject matter expert (SME) Risk Management: Identifies risks to project delivery and/or quality, leads in a way to minimize risks Anticipates risks to avert need for study level escalations, supports lead in implementing risk mitigation actions Lock and Unblinding Process: Leads the database lock and unblinding process for the statistical team Participate on the biostatistics randomization team (drafts randomization specifications and/or perform quality control (QC) review of randomization schedules) Statistical Expertise: Provide expert statistical input into review of statistical deliverables (i.e. statistical section of a protocol, statistical analysis plans, table shells, programming and table specifications, data review, tables, listings, figures, and statistical sections for complex and/or integrated reports) Provide expert input into data management deliverables (i.e. database design, CRF design, validation checks and critical data) Provide expert review of ADaM reviewers guide (ADRG) and metadata Perform senior biostatistical review (SBR) Produce or perform quality control review of sample size calculations for complex studies Requirements: Masters or PhD degree in Biostatistics or a related field with relevant experience within the life-science industry Expert in a broad range of complex statistical methods that apply to Phase 2-3 clinical trials Expert in strategically collaborating with clinical and drug development expertsExperience in serving as statistical lead for regulatory submissions, including preparation of submission datasets, eCTD support, meeting with regulatory teams, and responding to regulatory queries In-depth knowledge of applicable clinical research regulatory requirements, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Strong working knowledge of SAS or RExcellent knowledge of CDISC Data Standards Superb communication and collaboration skills Independent and pro-active problem solving skills IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
deine aufgaben: Networking ist alles! Du baust belastbare Beziehungen zu Experten, Entscheidern und Verbänden im medizinisch-wissenschaftlichen Bereich aus. Sei ganz vorne mit dabei! Zu deinen Kernaufgaben gehören die Entwicklung und Umsetzung regionaler Kundenstrategien in Zusammenarbeit mit dem Vertrieb, Marketing und Market Acces.
deine aufgaben: Networking ist alles! Du baust belastbare Beziehungen zu Experten, Entscheidern und Verbänden im medizinisch-wissenschaftlichen Bereich aus. Sei ganz vorne mit dabei! Zu deinen Kernaufgaben gehören die Entwicklung und Umsetzung regionaler Kundenstrategien in Zusammenarbeit mit dem Vertrieb, Marketing und Market Acces.
True financial experts are rare, in great demand and therefore have a high market value. Whether it's in Accounting, Controlling, Corporate Banking, Interim Management, Treasury or Risk Management – Hays will open doors for you and advise you completely free of charge regarding your next career move.
True financial experts are rare, in great demand and therefore have a high market value. Whether it's in Accounting, Controlling, Corporate Banking, Interim Management, Treasury or Risk Management – Hays will open doors for you and advise you completely free of charge regarding your next career move.
POSITION Reporting to the Director of Global Portfolio in the Human Health Division you will be part of the global portfolio management team and commercial development department. Your main task will be to act as expert within your category enabling profitable category sales growth through clear go-to-market strategy. Key responsibilities: Be category expert mastering key drivers for growth; consumer and customer insights coupled with understanding of the regulatory landscape and the competitive situation.
POSITION Reporting to the Director of Global Portfolio in the Human Health Division you will be part of the global portfolio management team and commercial development department. Your main task will be to act as expert within your category enabling profitable category sales growth through clear go-to-market strategy. Key responsibilities: Be category expert mastering key drivers for growth; consumer and customer insights coupled with understanding of the regulatory landscape and the competitive situation.
Key Responsibilities Medical science expertise: Act as trusted scientific expert, delivering accurate and compliant scientific and clinical education to external stakeholders. Present complex data in a clear and compelling manner, in oral and written form.