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Erfahren Sie mehr über:

Pharma &
Biotech

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Erfahren Sie mehr über:

Medizintechnik &
Diagnostik

Zum Gesamtüberblick

Erfahren Sie mehr über:

Engineering &
Construction

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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.

Einzelübersicht der Fachbereiche: Pharma & Biotech

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

Medizintechnik & Diagnostik

für Ingenieure und Naturwissenschaftler für den kompletten Produktlebenszyklus der Medical Device & Diagnostic Produkten von R&D über Quality, Produktion & Technik, Vigilance, Regulatory Affairs hin zu Sales & Marketing unserer Kunden.

Einzelübersicht der Fachbereiche: Medizintechnik & Diagnostik

Research & Development

• Design Control (DHF)

• Project Engineering

• Project Management

• Risk Management

• Validation & Verification

• Testing

• Test Method Validation

• Biocompatibility

• Technical Documentation

• Document Review / Remediation

Medical & Clinical Affairs

• Clinical Project Management

• Clinical Research

• Associate (CRA)

• Clinical Safety

• Medical Advisor

• Medical & Scientific Writing

• Clinical Evaluation Reports

• Post Market Surveillance (PMS)

Manufacturing / Production

• Clean Room

• Packaging / Labelling

• ProcessPlanning & Optimization

• Risk Management

• Site Planning

• Technology / Production Transfer

• Process Qualification

• Process Validation (DQ / IQ / OQ / PQ)

• Supply Chain Management (SCM)

Regulatory Affairs

• International Approvals

• UDI / Labelling

• Conformity

• Assessments / MDR

• Notified Bodies

• Document Review / Remediation

Quality Management

• Auditing (Internal, Third Party)

• Risk Management

• NC, CAPA, Complaint

• CSV

• QMS

• QMB

• Quality Assurance (QA)

• Quality Control (QC)

• Supplier Management (SQA)

• Document Review / Remediation

• Life Cycle Management

Cross-Functional Roles

• Controlling & Accounting

• Human Resources

• Procurement

• Project Management

• Change Management

Engineering & Construction

für Naturwissenschaftler und Ingenieure für den kompletten Lebenszyklus der Produkte und Anlagen von R&D über Quality, Produktion & Technik hin zu Sales und Marketing unserer Kunden.