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Helene DeconinckHD

Helene Deconinck

Pharma consultant

615 €/jour
Brussels, BE
8-15 ans

Délai de réponse moyen : 1h

À propos de Helene

Why work with me?

I am a pharmaceutical project and program management consultant, bringing both operational and strategic expertise built over more than 10 years in the pharma and biotech industry. I have led cross-functional assignments in regulatory affairs, clinical operations, quality, market access, and digital deployment across France and Europe. Bilingual in French and English, I support international projects covering diverse portfolios in OTC, oncology, and cosmetics.

I first gained technical expertise as a QC Biochemist at GlaxoSmithKline (France), then as a Clinical Project Manager at Johnson & Johnson (France). I went on to take roles in regulatory coordination and compliance at Pfizer (UK) and Pharmalex (Cencora, Germany), where I managed multiple outsourcing projects and programs with cross-functional teams of up to 20 people—covering budget definition/management, KPIs, and close-out. At Bristol Myers Squibb (France), I ensured the rollout and follow-up of digital oncology tools to improve patient care, while guaranteeing full legal and regulatory compliance.

The common thread throughout my career: acting as a bridge between science, operations, and external partners, ensuring compliance across portfolios and processes.

How I can help you?

  • Program/Project Management : steering clinical, regulatory, or quality projects; planning, budgeting, and vendor coordination.
  • Vendor Management : CRO/CMO selection and oversight, KPI implementation, document audit management, GxP compliance.
  • Digital Rollout & Training : deployment of digital tools (ERP, Veeva, SharePoint), user training, change management, and design of dedicated training campaigns.

  • Anglais

    Bilingue ou natif

  • Français

    Bilingue ou natif

Accepte de travailler sur site
Brussels (jusqu’à 50 km)

Expériences

  • Bristol Myers Squibb UK
    Market Access & Public Health - Project manager
    INDUSTRIE PHARMACEUTIQUE
    septembre 2024 - août 2025 (11 mois)
    Rueil-Malmaison, France
    • Clinical project support (non-interventional trial): coordinated between public institutions (FIAC) and private vendors/CROs to select, activate, and monitor trial sites. Ensured timelines and compliance for study launch.
    • Contract drafting & negotiation: drafted and refined contracts to clarify scope, deliverables, and data protection. Aligned legal and procurement terms across vendors, scientific committees, and investigator sites.
    • Stakeholder alignment: acted as liaison between legal, procurement, and scientific stakeholders, ensuring contract terms matched institutional policies and regulatory requirements.
    • Consensus building & project initiation: facilitated structured discussions to balance scientific objectives with operational constraints, leading to successful study approval and initiation.
    market access public health non investigational studies e-oncology
  • Cencora (PharmaLex)
    Program Coordinator
    INDUSTRIE PHARMACEUTIQUE
    janvier 2017 - juillet 2024 (7 ans et 6 mois)
    Mannheim, Allemagne
    • Project governance & execution : built and executed roadmaps, implementation plans, and reporting frameworks (meeting minutes, status reports, KPIs) to keep programs on track.
    • Team leadership in matrix setups : led and mentored cross-functional project teams (up to 20 people), ensuring alignment and high performance across regulatory, clinical, and operations.
    • Vendor management & onboarding : selected, onboarded, and trained vendors, maintaining performance through structured oversight and clear communication.
    • Contract & budget oversight : reviewed SOWs/PSAs, supported invoicing, and monitored project profitability via ERP (Microsoft Dynamics 365).
    • Cross-functional delivery : coordinated outsourcing programs (regulatory submissions, NDA planning, end-to-end local outsourcing) to achieve client and business objectives.
    SOP vendor risk management cross-functional coordination governance & reporting RfP/MSA/SLA/PSA/bid defense
  • Pfizer
    Project coordinator (QA)
    INDUSTRIE PHARMACEUTIQUE
    octobre 2015 - décembre 2016 (1 an et 3 mois)
    London, Royaume-Uni
    • Data migration & compliance monitoring : analyzed and tracked MAA data migration into a new eDMS system, ensuring accuracy and completeness during system launch.
    • Training & onboarding : designed communication plans and educational materials, training global and regional regulatory teams on compliant data entry.
    • Change management support : supported adoption of new digital processes, improving data quality and compliance across multiple regions.
    project coordination compliance training & onboarding quality control (QA)

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Formations

  • Master of Science Drug Discovery & Pharma management
    University College London
    2015
    Master of Science

Certifications

  • PMI Agile Certified practionner (PMI-ACP)
    Linkedin Learning
    2023
    Project Management Agile method

Compétences

Catégories