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Laure DAVID-ROUX

Paris

En résumé

International profile. Legal and compliance. Relocated to France.

Mes compétences :
Medical Devices
Legal Research
minimal supervision
NOTABLE SKILLS
Microsoft Word
Microsoft PowerPoint
Microsoft Outlook
Microsoft Excel
Managerial Skills
Management Reporting
Internal Audit
Intellectual Property Law
Functional management
Due Diligence
Audit

Entreprises

  • Teoxane - Head of legal

    Paris 2016 - maintenant
  • Eightstone Pte Ltd - Chief Operating Officer, Singapour

    2015 - 2016 Chief Operating Officer: organizing, supervising and coordinating the activities of the Legal, Compliance, auditing et accounting functions.
    Organizing the legal and regulatory framework; managing relations with market regulators and supervisory authorities; providing advice and training; acting as the permanent control correspondent; ensuring that the Company’s operating and accounting processes are performed in the best conditions of security and productivity; preparing accounting and management reports for Senior Management, Board, regulators and statutory auditors.
  • French Lab - Owner

    2014 - maintenant Bringing to Singapore some artisanal hand-made fashion products from France. Set up of the company, sale of products.
  • CRÈME SIMON- Regulatory consultancy - Consultant

    2013 - 2013 Consultancy and advice to a new Singaporean company, launching cosmetics: cosmetics regulations, advertising and publicity in Europe and Singapore, interpretation of laws, guidelines and rules applicable, compliance issues.
  • University of Lille - Teacher

    2011 - 2011 Pharmaceutical law master degree
    External consultancy: teacher in both French and English
  • ASTRAZENECA - Legal Department - Senior lawyer & providing legal counsel

    2006 - 2011 In house senior lawyer: providing legal counsel, strategic guidance and supporting the business and all departments on a day-to-day basis.
    Drafting and negotiating a wide variety of contracts: co-marketing, promotion, manufacturing, advertising, distribution, consultancy, clinical research, IT related agreements, etc. (French/English); providing legal advices on matters relating to business and commercial law, pharmaceutical law, competition law, regulatory, compliance; supporting business initiatives; liaising with and being the contact point for outside counsel. Supporting Procurement department (RFI, RFP, negotiation, selection, signature and contract operational follow-up) Responsible for handling various litigation matters (commercial, contracts, product liability) and manage all internal and external investigations related to the business.

    In addition, in charge of specific areas:
    * Intellectual Property matters ;
    * Data Privacy: guidance and counsel for France, review of the website content and policies ;
    * Functional management of the legal team ;
    * Project manager to set up and implement a new contracts database: choice of the service provider, customization of the database, training of employees, and integration in the contracts process.
    * Responsible, with recognized success, for the entire review of contracts procedures: coordination of all team members of the project (business lines, marketing, legal, compliance...), interview of key people, due diligence, process optimisation, and redefinition of process key roles.
    * Validation and adaptation to local constraints of contracts templates coming from the corporate (clinical trials, co-promotion agreements, commercial agreements, licensing agreements)
    * Creating services agreements referring to corporate MSA (co-promotion in Cardiology).

    Supporting the compliance team in its day-to-day work:
    * Provide guidance and counsel on compliance policy interpretation and implementation,
    * Review and validation of templates documents, SOP, contracts for compliance clauses and training materials,
    * Implementation of FCPA in France: training of employees, definition of the policies and the process, development of training materials and of website, modifying contracts clauses and templates documents,
    * Interface with compliance team, working on a day-to-day basis with them, regarding French anti-corruption regulation, HCC, FCPA, code of conduct and ethical issues, requirements and implementation. Translation of global strategies into regional and local level, based on appropriate local needs, goals and objectives, taking into account local external regulatory trends and environment.
    * Co-lead internal audit and external investigations.
  • JANSSEN-CILAG - Supporting the legal Director

    2000 - 2006 JANSSEN-CILAG (Johnson & Johnson) - Legal Department
    Working on the 3 integrated businesses of the Group: Pharmaceutical, Medical Devices, Consumer healthcare/Cosmetics.
    Dealing with business law, negotiation and drafting contracts in both French and English, pharmaceutical and regulatory rules, commercial issues (drafts/litigation), implementation and respect of internal procedures, training of employees on pharmaceutical law, consultant for operating people, drafting, review and update of clinical research agreements.

    In charge of all matters relating to ``DMOS'' issues (French regulation against gifts to healthcare professionals):
    * Implementation of the process and of a code of good practice, implementation of the anti-corruption and anti-bribery program (definition of the process and training of employees regarding competition law, in order to make them sensitive to risks, to investigation and dawn raids from French and European authorities, and on careful writing).
    * Training of new employees and annual refresher training (meeting, annual sales force event...),
    * Lead internal audit, reviewing data to identify potential breach of regulation, process gaps and inconsistencies by the employees. Check the database where were collected data from employees, bills of expenses. Analyse the data collected, provided feedback, wrote a report to the management board with my conclusions in order to guide the management to close gaps and implement corrective actions and also to demonstrate that the process was or was not effective.
    * Participation in external audit (investigation from French or European authorities)

    Key member of the corporate team conducting a due diligence for a medical devices company acquisition;

    Supporting the legal Director in a ``dawn raid'' leaded by the European Commission related to a competition law matter;
  • JANSSEN-CILAG - Trainee

    2000 - 2000 JANSSEN-CILAG (Johnson & Johnson) - Trainee in the Legal Department
    Under supervision of the General Counsel, in charge of the legal database, drafting legal memos, legal research.
  • PHARMACIA & UPJOHN - Trainee

    2000 - 2000 PHARMACIA & UPJOHN - Trainee in the Legal Department
    Under supervision of the General Counsel / Senior Lawyer, legal research, drafting contracts.

Formations

  • INTERNATIONAL COMPLIANCE TRAINING ACADEMY (Singapour)

    Singapour 2014 - 2014 ICA Advanced certificate in Governance

    ICA Advanced certificate in Governance, Risk and Compliance (IBF Level 1) – Graduated
    in December 2014.
    - Demonstrate understanding of the financial services industry from a compliance perspective as well as awareness of industry trends and developments related to the compliance function,
    - Research, gather data, and complete an analysis of compliance matters under supervision of senior c
  • University Of Paris XI

    Paris 1999 - 2000 Master of Laws

    : specialization in Pharmaceutical domain (``DESS)''
  • University Of Limoges (France)

    Limoges 1995 - 1999 Master

    NOTABLE SKILLS

Réseau

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