Pharma | Biotech
Alle Fachbereiche auf einen Blick: Pharma & Biotech
Für Pharmazeuten, Naturwissenschaftler und Ingenieure für den kompletten Lebenszyklus der Arzneimittel von R&D über Quality, Produktion & Technik, Medical Marketing hin zu Market Access und Pricing & Reimbursement unserer Kunden.
RESEARCH & DEVELOPMENT
• R&D Scientist
• Drug Discovery & Preclinical PK / PD Modeling
• Toxicology & Pharmacology Formulation
• Development & Galenic
• Analytical Development
REGULATORY AFFAIRS
• Global Regulatory Consulting (IND, IMPD, BLA, DMF)
• Regulatory Writing Modul 1-5
• Life Cycle Management / Maintenance
• CMC Writing
• Art Work / Labeling
• MAH Transfer
• Information Officer § 74a AMG
• Regulatory Operations
• Global Regulatory Submission
• eCTD Management
CROSS-FUNCTIONAL ROLES
• Human Resources
• Procurement
• Project Management
• Supply Chain Management
• DSGVO / GDPR
CLINICAL RESEARCH
• Clinical Development
• Clinical Project Management
• Clinical Research
• CRO Management
• Clinical Operations
• Biostatistics
• SAS Programming
• Clinical Data Management
MEDICAL MARKETING
• Brand Management
• Medical Marketing
• Promotional Material
• Product Management
• Multi Channel Marketing
• PR Management
BUSINESS DEVELOPMENT
• Business Development
• Business Unit Director
• In- & Out-Licensing
• Portfolio Management
• Sales Force Effectiveness
DRUG SAFETY / PHARMACOVIGALANCE
• Drug Safety Management
• (EU-) QPPV / Stufenplanbeauftragter
• PV System Management (E2B R3)
• Risk Management Plan
• Signal Detection
• PSUR / DSUR Writing
• Case Management
• PV Training
MANUFACTURING / PRODUCTION
• CMO Management
• Manufacturing
• Management
• Process Management
• Packaging
• Production Management
• Technology Transfer
MEDICAL AFFAIRS
• KOL Management
• Medical Advisor
• Medical Director
• Medical Information
• Medical & Scientific Writing
• MSL
• Medical Education
QUALITY
• Quality Management System
• Quality Assurance
• Quality Control
• Qualified Person
• CAPA Management
• Deviation Management
• Analytic
• Global GxP Audits
• CSV
• IT-Validation
• Data Integrity
• Validation & Qualification (Cleaning, Equipment, Processes, Methods)
• Laboratory Management
• Supplier Management
MARKET ACCESS
• HEOR / HTA
• AMNOG
• Market Access
• Pricing & Reimbursement
• Value Dossier Writing
• Tender Management