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Gérald ORLIK

Paris

En résumé

Currently Head of Ethics & Business Integrity General Medicines at Sanofi, a position held since April 2020.

Previously at Sanofi, Global Business Partner Ethics & Business Integrity for CHC and China & Emerging Markets Global Business Units from 2016 to 2020 and before Associate Vice-President, Europe Region Compliance Officer, from 2011 to 2015.

Prior to joining Sanofi, I served as VP & EMEA Chief Compliance Officer at Mylan, member of the EMEA Executive Committee. I created the function, designed and implemented the compliance program for EMEA region. Before Mylan, I was Compliance Director for Schering-Plough France (human and animal health), a member of the executive committee for the French subsidiaries, overseeing all compliance-related matters for both human and animal health operations, primarily focused on Sales & marketing activities also covering clinical trials, medical affairs and manufacturing. I previously had varied industry experiences in the field of global risk management services with the audit and advisory services firm PricewaterhouseCoopers.

Graduated with management controlling from one of the top French universities in finance and economics (Universite Paris-Dauphine), I completed a masters degree in computer sciences. I am also graduated from the French Higher Staff College for reserve officers (ESORSEM) and BTEMG (CESAT).

Specialties:
* Project management
* Internal control, risk management
* FCPA matters and data privacy
* Sarbanes-Oxley projects

Entreprises

  • Sanofi - Head of Ethics & Business Integrity General Medicines Global Business Unit

    Paris 2020 - maintenant Global scope for 2 therapeutic areas (diabetes & cardiovascular) and for the established products.
  • Sanofi - Global Business Partner, Ethics & Business Integrity

    Paris 2016 - 2020 Ethics & Business Integrity Business Partner for two Global Business Units (GBU)
    - Consumer HealthCare (CHC) – since January 2017
    - General Medicines & Emerging Markets (GEM) – since January 2016

    Member of the GBUs Leadership Teams

    Scope:
    • Worldwide for Established Products, Generics and CHC activities.
    • Emerging markets for all activities of Sanofi Group except Vaccines.
    Main activities and responsibilities:
    • Provide strategic E&BI leadership and support to the two GBUs projects and initiatives;
    • Act as primary point of contact for the two GBUs for implementing, promoting and enforcing E&BI standards;
    • Support Global E&BI in addressing strategic priorities and serve as the liaison between the two GBUs and the Global E&BI organization.
  • Armée de terre - Chef de corps

    2013 - 2015
  • Sanofi - Associate VP, Regional Compliance Officer Europe

    Paris 2011 - 2015 Member of the Europe Management Committee
    Scope:
    • All activities of Sanofi Group within the region (Human health, OTC, generics, Animal Health, Vaccins, Industrial Affairs, R&D…).
    Main activities and responsibilities:
    • Region
    o Recruit, train and lead the Europe compliance officers network;
    o Ensure effective deployment of the Sanofi compliance program for Europe;
    o Contribute to embed compliance dimension into the decision making process at Europe
    Management Committee level.
    • Global
    o Supervising the whistleblower line (ex US) – September 2011 to March 2014;
    o Participate to the drafting and/or review of group Policies in relation with compliance topics;
    o Septembre 2011 to April 2012
     Build and lead a workgroup for reshaping the global Sanofi compliance organization;
     Coordinate the corporate compliance team until the appointment of the global compliance
    officer;
     Ensure interim of the Latin-America Region compliance officer until his hiring.
  • Mylan - Vice President EMEA & Chief Compliance Officer

    Saint-Priest (69800) 2009 - 2011 Member of the Europe-Middle-East-Africa Executive Committee (EEC)

    Goals:
    - Create a Compliance Governance for EMEA region, relying on local compliance officers
    - Ensure that a proper management of Standard Operating Procedure (SOP) and Policies is in place in each country (written policies and procedures)
    - Design and apply a Compliance Training and Education Plan for the EMEA region
    - Promote the risk-based approach and implement a risk mapping process
    - Implement the Whistleblower Line and the Code of Conduct across the EMEA region
  • 8RT

    Suresnes 2008 - 2012
  • Schering-Plough - Director Compliance & Business Practices

    Levallois-Perret (92300) 2006 - 2008 Member of the French subsidiaries Management Teams (Schering-Plough S.A. and Schering-Plough Vet).

    Scope:
    - Human health and Animal health businesses
    - Primarily focused on Sales and marketing activities also covering other activities such as Clinical trials, Medical affairs and manufacturing locations.

    Main activities and responsibilities:
    - Helps embed business integrity and compliance behavior into the local operations and processes, in an effective and efficient manner;
    - Identifies inefficient or ineffective business processes, works with responsible management in a cross functional approach to streamline such processes, including elimination of compliance roadblocks;
    - Drives S-P’s Compliance program in the company’s local international operations;
    - Works cross functionally in investigations and resolving individual compliance;
    - Assists in the organization, development and implementation of training programs as well as measuring the effectiveness of these programs
    - Oversees the day-to-day implementation of corporate strategic privacy initiatives, and for responding to privacy issues that may arise locally;
    - Conduct privacy risk assessments and oversee remediation efforts in the Country Operation. Help to coordinate privacy audits, and implement audit recommendations and audit training for appropriate staff.

    Major contributions: Launch of an ERM (Enterprise Risk Management) initative, project leader for the improvement of the operational effectiveness in 3 major business processes in a cross functional team (Business units, Finance, Legal, Purchasing and IT), Training and Communication toward line management and employees (developpement of e-trainings, animation of Sales meetings, …), development of a compliance training matrix and employees continuous training pathway.
  • GIACM - ...

    2002 - 2008
  • PricewaterhouseCoopers - Director

    Neuilly-sur-Seine 2000 - 2006 Department Performance Improvement, Risks & Internal control

    * Leading and coordinating, « Sarbanes-Oxley Act » and « Loi de Sécurité Financière » compliance projects for worldwide firms.
    --> Major contributions: Regulation watch, communication plan, methodology support, mobilization/training programs over internal control concept and approach to document/assess internal control, risk assessment, project management, leading teams of consultants (1 to 15 depending on projects/phases), customer relationship and invoicing management.

    * Trainer for the Eurofirm accreditation training program « focus on integrated audit » required for financial auditors (US GAAS) that are involved on SEC registrants (400 people trained in 2004).
    --> Main topics covered: Regulation context (US, Europe, France), scoping (quantitative and qualitative analysis of financial statements, risk factors analysis, identification of accounts/processes/locations to be reviewed), internal control assessment (walkthroughs, evaluation of design efficiency, evaluation of operating effectiveness-testing, synthesis of control gaps/internal control deficiencies and reporting), integration with the audit of financial statements.

    * European IT internal audit coordinator for a French international company (mainly in Europe and in the USA):
    --> Content: Risk factors analysis, design of the draft audit plan, planning and management of the assignments, review of the deliverables, closing meeting, budget follow-up and invoicing management.

    * Chairman of the PwC European workgroup (Eurofirm) on the « internal control improvement » topic:
    --> Main themes: Internal control threats/opportunities for companies (regulation/value added/business process control), tools and methodologies, lesson learned in Europe and in the US, communication action plan, training program, set up of a network of experts.

    * Audit assignements: projects reviews, information systems and business process internal control reviews, methodological support for « Sarbanes-Oxley 404 » and « LSF » engagements.
    Internal control public presentations at conferences: CompTIA

    * European Electronic Commerce Standards Board (e-ECSB) in Grenoble (02/2005), DFCG (French Association for CFO and controllers) (06/2005).
  • KDI - Management controller and development manager for the Management Controlling department

    1998 - 2000 - Project leader for the reshaping and the standardization of the reporting process (local, region and France), selection and implementation of a BI tool to cover regions and France reporting, implementation of key performance indicators.
    - Key user controlling CO (SAP), advises and support for a subsidiary implementing FI/CO/TR. (SAP).
    - Training logistic managers (région and local) to management concepts and tools (controlling, business unit P&L, reporting).
  • 8RT - .....

    1997 - 2002
  • Steria Group - Chief Engineer - Senior Consultant

    Paris 1996 - 1998 Entreprises et Service industries Department
    - Consulting: Communication strategic planning, feasibility and opportunity study, specifications, user acceptance testing, projects management, Activity Based Costing (ABC) implementation project.
    - Commercial development: market studies, prospection, service proposals.
    - Internal roles: quality manager, counselor for about fifteen collaborators (assignments, training plan, yearly summary appraisal, career plan), recruitment.
  • 70RIMa

    Monthléry 1993 - 1997
  • Universal Music - Domains Manager

    Antony (92160) 1991 - 1995 Universal Music (formerly Polygram)

    Domains manager: Accounting/Finance domains then Logistic. Design and follow-up of development and maintenance budgets.

    Project leader for France of the international royalties management project, in charge of copyright and artist accounting applications.
  • 102RCS

    Versailles 1990 - 1993

Formations

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