Experienced Medical Affairs Physician/Consultant/Writer & Managing Director
- Verfügbarkeit einsehen
- 0 Referenzen
- auf Anfrage
- 13465 Berlin
- National
- de | en | es
- 01.10.2024
Kurzvorstellung
Qualifikationen
Projekt‐ & Berufserfahrung
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
Business-To-Consumer, Content Management, Content Marketing, Management (allg.), Medical Writing, Microsoft Office 365
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
Humanmedizin, Innere Medizin, Medical Writing, Medizin, Medizinforschung, Projektmanagement, Regulatory Affairs, Strategisches Marketing
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
Content Management, Projektmanagement (IT), Projekt - Start-Up-Workshop
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
Drug Discovery, Pharmakologie, Pharmazie
Zertifikate
Ausbildung
Berlin
Berlin
Persönliche Daten
- Deutsch (Muttersprache)
- Englisch (Fließend)
- Spanisch (Fließend)
- Französisch (Grundkenntnisse)
- Europäische Union
Kontaktdaten
Nur registrierte PREMIUM-Mitglieder von freelance.de können Kontaktdaten einsehen.
Jetzt Mitglied werden