Michał Kozioł

senior compliance officer

There are two main areas of importance when building compliance programs - protecting companies from abuses while still ensuring the efficiency of business processes.

Michał Kozioł

healthcare compliance officer

"There are two main areas of importance when building compliance programs - protecting companies from abuses while still ensuring the efficiency of business processes."

Experience

Valeant

Novartis

Johnson & Johnson

Deloitte

Ernst & Young

Astra Zeneca

Roche

Infarma


Scope of support

  • High-workload periods

    Support provided when compliance deptartments face high-workload periods due to:
    1. Activities review (audits) - gathering and providing information, channeling questions and answers from/to audit teams, supporting overloaded compliance processes
    2. Periodic employees certifications (i.e annual). Conducting compliance certifications, designing and reviewing compliance presentations, internal communication. Supporting other compliance processes during certification.
    3. Supporting (Sunshine Act) implementation projects.
    4. Implementing post-audit recommendations.
  • Compliance projects

    Managing compliance projects:
    1.Marketing, market access, patient programs reviews and analysis.
    2. Implementing new compliance processes and procedures.
    3. Conducting trainings and internal communication.
    4. Procedures, SOPs, processes, anti-bribery, anti-fraud design and reviews. Increasing effectiveness, gap analysis, anti-bribery, anti-fraud analysis.
    5. Compliance projects planning and implementation support.
    6.Conducting and supportingcompliance reviewsand internal compliance audits.
  • Compliance communication

    Compliance internal communication:
    1. Organizing and carrying out internal conferences
    2. Composing and reviewing compliance presentations, and other communication channels (intranet, newsletters, mailing).
    3.Building employees engagement strategies .

Why would you want to hire an external compliance consultant

Expertise

A consultant may be hired because of his expertise that is not available within an organization

Problems identification

A consultant may be hired to identify problems. Very often employees are too close to a problem inside an organization to identify it.

Knowledge

Consultant can be hired to provide employee trainings, induction programmes, bringing up-to-date knowledge and skills to organization so it can stay competitive.

Supplementing compliance teams

An external consultant can be hired to support an existing compliance team. Generally it makes good economic sense to hire a consultant when they are needed, rather than hiring full-time employees.

Objectivity

A good consultant provides an objective, fresh viewpoint. A good consultant will perform project not being influenced by interpersonal or political factors.

Changes

Nobody likes changes, but they are necessary at times. A consultant may act as a change-catalyst and be hired to manage the change and overcome issues that get in the way when an organization is trying to institute change.

Ideas

An external consultant may be hired to implement an innovative and unique idea.

Innovative solutions

Consultant can be hired to bring "fresh-air" to organization, new ideas and innovative solutions.