freiberufler Experienced Medical Affairs Physician/Consultant/Writer & Managing Director auf freelance.de

Experienced Medical Affairs Physician/Consultant/Writer & Managing Director

zuletzt online vor wenigen Tagen
  • auf Anfrage
  • 13465 Berlin
  • National
  • de  |  en  |  es
  • 17.04.2024

Kurzvorstellung

10+ year's Medical Doctor with pharmaceutical industry experience and deep cross-functional, economic and managing experience in the field of Oncology, Hematology, Dermatology & Vaccines.

Qualifikationen

  • Business-to-Consumer (B2C)
  • Content Management
  • Content Marketing
  • Digitalisierung
  • Humanmedizin
  • Klinische Studie
  • Management (allg.)
  • Medical Writing
  • Medizin
  • Microsoft Office 365
  • Pharmaforschung
  • Projektmanagement
  • Projektmanagement - Vorstudien / Machbarkeitsstudien
  • Regulatory Affairs Management
  • Strategisches Marketing

Projekt‐ & Berufserfahrung

Launch Lead & Senior Medical Affairs Hematooncology (Festanstellung)
Pfizer GmbH, Berlin
3/2023 – offen (1 Jahr, 3 Monate)
Chemieindustrie
Tätigkeitszeitraum

3/2023 – offen

Tätigkeitsbeschreibung

• Strategic Planning & Execution of Launch in close collaboration with Marketing, Market Access, Health & Value, Payer, Regulatory
• Leverage of regional and global medical initiatives to meet local business needs
• Development and delivery of expert training programs to internal and external stakeholders
• Build and maintain a network of important key scientific/opinion leaders, KOL-interactions. Regulatory Bodies and KOL Mapping
• Preparation and approval of materials, product presentations, publication plan and implementation
• Engagement in external meetings, advisory boards and symposia
• Medical Evidence & Initiation of Investigator-initiated Clinical trials, NIS & Research Collaborations
• Use of Veeva Vault (cGCMA, mGCMA), Veeva Promomats, Veeva Link and CRM

Eingesetzte Qualifikationen

Business-to-Consumer (B2C), Content Management, Content Marketing, Management (allg.), Medical Writing, Microsoft Office 365

Senior Medical Affairs Physician Vaccines & Immuntherapies (Festanstellung)
AstraZeneca GmbH, Hamburg
12/2021 – 2/2023 (1 Jahr, 3 Monate)
Life Sciences
Tätigkeitszeitraum

12/2021 – 2/2023

Tätigkeitsbeschreibung

• Execution and delivery of regional Medical Affairs plans incl. budget responsibilities
• Build and maintain a network of important key scientific/opinion leaders, KOL-interactions
• Planning of effective medical education campaigns, scientific advisory boards, KOL engagements, webinars, symposia and presentations
• Cross-functional activities regarding launch of products incl. Market Access, Governmental Affairs, Legal and Communications
• Development and delivery of expert training programs to internal and external stakeholders
• Answer medical requests and level support of medical information
• Collaboration and cross functional interactivity with Global, DACH and EUCAN
• Medical-Scientific support in creating non-promotional and promotional material and communication and review via review systems
• Support of clinical studies and non-interventional studies

Eingesetzte Qualifikationen

Humanmedizin, Innere Medizin, Medical Writing, Medizin, Medizinforschung, Projektmanagement, Regulatory Affairs Management, Strategisches Marketing

Medical Advisor Prostate Cancer/Breast Cancer (Festanstellung)
Takeda Pharmaceuticals, Berlin
6/2020 – 12/2021 (1 Jahr, 7 Monate)
Chemieindustrie
Tätigkeitszeitraum

6/2020 – 12/2021

Tätigkeitsbeschreibung

• Medical responsibility for all Urology and Gynecology products
• Execution and delivery of regional Medical Affairs plans incl. budget responsibilities
• Build and maintain a network of important key scientific/opinion leaders, KOL-interactions
• Planning of effective medical education campaigns, scientific advisory boards, KOL engagements, webinars, symposia and presentations
• Speaker briefings of sponsored events
• Participation in outcomes research/health economics engagements with national payers, Health Technology Assessment or regulatory agencies, in coordination with Real-World Evidence, Market Access, Compliance and Commercial colleagues
• Medical-Scientific support in creating non-promotional and promotional material and communication and review via review systems
• Support of clinical studies and non-interventional studies
• Development and delivery of expert training programs to internal and external stakeholders
• Answer medical requests and level support of medical information
• Collaboration and cross functional interactivity with Global and EUCAN
• Lead and finalize digital projects
• Screening and development of medical science literature, i.e., write, edit and publish scientific articles and papers
• Use of Veeva Vault Promomats and Veeva MARV, Veeva CRM

Eingesetzte Qualifikationen

Content Management, Projektmanagement (IT), Projekt - Start-Up-Workshop

Drug Safety Physician (Festanstellung)
Takeda Pharmaceuticals, Berlin
6/2014 – 5/2020 (6 Jahre)
Chemieindustrie
Tätigkeitszeitraum

6/2014 – 5/2020

Tätigkeitsbeschreibung

• Monitoring the safety and benefit-risk profile of assigned portfolio in an ongoing fashion
• Identifying, prioritizing and analyzing clinical safety signals
• Performing ongoing review of emerging safety data from various sources including single case reports, Product Technical Complains (PTC) and published literature and reports from partner functions
• Performing clinical safety risk communication and escalation within PV Management, the Qualified Person for Pharmacovigilance (QPPV), to Safety Committees and Governance bodies
• Producing responses to regulatory queries
• Ensure adequate product information of safety related aspects, PIL
• Ensure effective and timely delivery of PSUR/PBRERs, DSURs and RMPs
• Reference safety information and relevant Position paper and Justification documents
• Answers to assigned safety-relevant requests from health authorities
• Provide high quality medical input to product teams to support life cycle management
• Provide medical safety oversight of data in the context of the medical review processes
• Interact with license partners to support the Global license officer in the preparation and maintenance of PV agreements
• Preparation of medical reports and answering medical inquiries
• Assistance in internal department control and quality assurance (deviations and CAPA, audit management) as well as participation in audits and inspections
• Creation, maintenance and updating of SOPs, Pharmacovigilance System Master File (PSMF), pharmacovigilance contracts

Eingesetzte Qualifikationen

Pharmaforschung, Pharmakologie, Pharmazie

Zertifikate

Product Owner
2021
GCP
2021
SCRUM Master
2020

Ausbildung

Master of Business Administration
MBA General Management
2020
Berlin
Humanmedizin
Promotion
2014
Berlin

Persönliche Daten

Sprache
  • Deutsch (Muttersprache)
  • Englisch (Fließend)
  • Spanisch (Fließend)
  • Französisch (Grundkenntnisse)
Reisebereitschaft
National
Arbeitserlaubnis
  • Europäische Union
Home-Office
bevorzugt
Profilaufrufe
347
Alter
37
Berufserfahrung
12 Jahre und 3 Monate (seit 02/2012)
Projektleitung
4 Jahre

Kontaktdaten

Nur registrierte PREMIUM-Mitglieder von freelance.de können Kontaktdaten einsehen.

Jetzt Mitglied werden