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Nathalie GHERARDI

FRANCE

En résumé

Mes compétences :
Relations Publiques
Relations européennes
Compliance
Affaires réglementaires
Enregistrement
Affaires publiques françaises
Gestion de projet
Affaires publiques européennes

Entreprises

  • InfoSanté - Strategy Manager

    2018 - maintenant Redifine the whole business model and business plan in order to regain market shares and become an agile and strong actor on the market.
    In direct collaboration and report to the CEO:
    o Definition of the new business model and business plan
    o Elaboration of the recommendations
    o Managing the P&L. Reformed the business with an increase of 25%
    in cash reserves over eight months.
    o Devised innovative R&D methods using Agile frameworks.
    Implemented the use of JIRA.
    o Prepared the company’s flagship product for the latest government
    approval.
    o Increased the value proposition with new partnerships (Doctolib,
    Saficard, Techdata).
  • Laboratoire Msd France - Partnerships Manager Oncology

    2017 - maintenant • Business unit strategy:
    o Definition and elaboration of strategic communication and actions plans
    o Implementation of the actions plans in collaboration with all the involved departments (Marketing, Market Access, Sales force, Medical Affairs)

    • Projects management:
    o Lead on the development and implementation of a patients communication campaign (mix of digital and non-digital)
    o Participation to the digital transformation of the Oncology direction
    o Management of the involved teams and the service providers
    o Follow-up of the contracts and budgets

    • External Affairs:
    o Development and management of partnerships with patients associations and key stakeholders
    o Definition and management of the relevant congresses and sponsoring to raise MSD Oncology reputation
    o Identification of the key groups and stakeholders and development of the network to implement MSD Oncology in the business
    o Representative for MSD Oncology with the scientific leaders, advocacy groups and authorities
  • Laboratoire Msd France - Public Affairs Specialist

    2015 - 2017 • Public Affairs on products portfolio:
    o Definition and elaboration of strategic plans for relevant therapeutic areas (Oncology, HCV, Neurodegenerative diseases)
    o Implementation of the actions plans in collaboration with all the involved departments (Marketing, Market Access, Regulatory, Business Units)
    o Regulatory monitoring and analysis of the external environment for the priority therapeutics areas

    • Projects management:
    o Lead on the development and implementation of a digital patient support program in HCV
    o Lead on the elaboration of a white paper in Oncology
    o Management of the involved teams and the service providers
    o Follow-up of the contracts and budgets

    • Institutional Affairs:
    o Day watch and analysis of public politics and fundamental stakes regarding Health policy
    o Representation and defense of the interests and position of the company within the framework of legislative or statutory procedures
    o Active participation to internal, external and institutional workshop and products workshop
    o Representative for MSD France with the public authorities and KOLs
  • GC Inc. - Regulatory & Public Affairs Manager

    2014 - 2015 • Consulting agreement with EBE
    o Coordinating EBE Public Affairs Working Group activities, finalising EBE MEP mapping,
    establishing and implementing the plan for EBE advocacy outreach.
    o Coordinating EBE Personalised Medicines Working Group activities and finalising the related white paper.
    o Advocacy Strategy, Plan and Implementation of Advanced Therapies Regulation Revision.
    o Provide Assistance for Regulatory Training Seminar 2014 and establish the plan for 2015 training seminar.
  • MSD, Europe Inc. - Public Policy Officer

    2014 - 2014 • Public Affairs
    o Development of advocacy plans (stakeholders mapping, project plan, milestones) for biologics policy and oncology
    o Countries dashboard objectives analysis and support to the European teams on the policy issues
    o Development of Position Paper

    • Participate in the respective internal and external team projects meetings

    • European Affairs:
    o Support outreach advocacy toward EU institutions on legislative projects
    o Development and implementation of actions plans on different issues (advocacy game)
  • Takeda France SAS - Regulatory Affairs Projects Manager

    2007 - 2014 • Products portfolio management:
    o Management and follow up of the registration files and the marketing authorization
    o Clinical trials management against the regulatory part
    o Collaboration with the Market Access team for the reimbursement dossiers

    • Projects management:
    o Monitoring of the regulatory intelligence
    o Identification, development, deployment and follow-up of French and Corporate projects
    o Conception and follow-up of the drug products packaging

    • Interprofessional and institutional expertise and communication:
    o Contribution to the products strategies development
    o Active participation to internal, external and institutional workshop and products workshop
    o Answer the French and European authorities requests
    o Representative for Takeda France with the Institutional
    o Training of the task force and the employees on the Internal SOP and regulatory good practices

    • Professional, educational and institutional marketing
  • Quintiles - Regulatory Affairs Projects Assistant

    Durham 2006 - 2007

Formations

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