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Laura STRÄHLE

RUMILLY

En résumé

Strong scientific background with experience in clinical development, communications and clinical document preparation within the pharmaceutical and tobacco industries. Certified Project Management Institute (CAPM)

• Plan, manage and coordinate projects with a strong sense of priority and urgency
(Clinical trials / communications / trainings / events)
• Produce high quality communications materials converting technical, clinical and scientific language into concepts and wording accessible for different audiences
• Ensure compliance with strictest legal and regulatory (FDA) requirements, and ICH/GCP guidelines
• Rapid understanding of scientific/clinical data and production of key messages, summaries and presentations in a timely manner.
• Prepare for and manage issues and crises in close collaboration with stakeholders at different level
• Develop and cultivate effective professional network in a matrix environment


Specialities
• Pharmaceutics and tobacco
• Therapeutic areas (Neurology, Immunology, Rheumatology, Virology)
• BoExp and risk markers: CVD, respiratory diseases, cancer
• Products in development, marketed products, incl. medical devices
• Planning, organisational and collaboration skills
• Issue and crisis management (clinical/communications)
• ICH/GCP
• FDA
• PR expertise, Media Relations expertise (20 press releases/Q&As and 10 position statements/Q&As per year), communication strategy
• Scientific, medical, clinical information understanding
• Summarising and key messaging skills
• Project management
• Drive communications activities and media relations activities with strictest legal & regulatory requirements
• Interface with global functions (Marketing, Medical Affairs, Clinical, Legal, Regulatory, Alliance Management, IP), Corporate Communications, Investor Relations, affiliates and partners
• Excellent interpersonal collaboration skills appreciated by the business

Entreprises

  • Philip - Clinical Scientist

    2014 - maintenant Act as the scientific leader for assigned clinical studies (devices) and clinical projects according to the study plan within the Product Assess & Scientific Substantiation (PASS) department.

    Achievements
    ➢ Develop clinical scientific documents in line with SOPs/ WIs and ICH/GCP & FDA guidelines (e.g. study protocols and amendments, protocol summary, fact sheets)
    ➢ Review clinical documents and data (e.g. laboratory documents, statistical and data management plans, study reports)
    ➢ Support to clinical team by providing scientific input and expertise (e.g. regulatory submission, investigator meetings)
    ➢ Contact point with multiple internal and external functions as well as with partners

  • Merck Serono - Media Relations Manager

    Lyon 2009 - 2012 Key responsible person for managing media communications activities related to the Neurodegenerative Diseases and Rheumatology business sectors (>10 products), covering the full range of media related projects in compliance with strictest legal & regulatory requirements and company policies & strategy.

    Achievements

    ➢ Ensured timely and successful implementation of communications and media relations programs in line and beyond disclosure policy: develop communication plans, produce communication material, such as press releases (announcement of clinical trial results, business partnerships, product and indication launches, etc.), company position statements, Q&As, backgrounders, factsheets, ensure daily media monitoring and proofreading material, etc.
    ➢ Supported global functions for the preparation and review of documents and product updates (slide presentations, fact-sheets, backgrounders, annual/financial reports, etc)
    ➢ Managed and coordinated efficiently and media enquires, interviews, feature articles, daily media monitoring, media event organisation in a timely manner
    ➢ Prepared for and supported issues and crises management initiatives
    ➢ Contributed to building and protecting corporate and product reputation by ensuring accuracy of key messages and adherence with corporate policies & strategy
    ➢ Effectively liaised with global stakeholders (Marketing, Medical Affairs, Medical Communications, Legal, IP function, Safety, Regulatory, etc), Corporate Communications, Investor Relations and affiliates
    ➢ Developed and nurtured effective internal and external professional relationships, notably with industry partners, facilitating mutual agreement on communication messages
    ➢ Actively participated in the integration and management of colleagues

  • Merck Serono - Clinical Trial Manager

    Lyon 2007 - 2009 Responsible for the Clinical Trial Management projects and activities of the REFLEX and REFLEXION Phase III studies, evaluating Rebif, one of the leading treatments for patients suffering from multiple sclerosis.

    Achievements
    ➢ Drove timely and successful execution of the assigned clinical trials in development according to the Clinical Development Plan in line with Good Clinical Practice
    ➢ Closely managed and supported the clinical projects/activities of 15 countries/43 sites (creation of contracts & budget sheets; payment processing; accruals; distribution of safety reports; etc.)
    ➢ Reviewed and provided input into trial related documents (Protocol, Amendments, Monitoring Reports, Study Aids, Investigator File, minutes, etc.) in agreement with Standard Operating Procedures & Working Instructions
    ➢ Ensured preparation of clinical trial documents for submission to Ethic Committees & competent Health Authorities
    ➢ Interfaced with multiple internal and external functions (Trial Team, Medical responsible, Biostatistics, Safety, Regulatory, Legal, Translators, Vendors, Clinical Research Organizations, institutions/hospital representatives, etc.)
    ➢ Managed three Clinical Trial Coordinators
    ➢ Organised Trial Team meetings, conferences, trainings and Investigators Meetings

Formations

  • Université De Genève (Genève)

    Genève 2003 - 2007 Doctorat

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