Healthcare Compliance Manager

Successfully completed various controlling projects

Over 20 years of experience as a Freelance Consultant in Pharma and Compliance

Extensive awareness of industry-specific compliance, legal and statutory requirements applicable at various levels in the delivery of quality outcomes

Compliance Expert adept at leading compliance, risk, governance, and project management at local, regional, and international level in the life science sector

Full hands-on and fresh approach on all activities related to Legal Affairs & Compliance

Implementation of regular compliance monitoring

Manage Third Party Due Diligence program

Code of Conduct (Implementation)

Healthcare business integrity

Preparation of an internal audit

Develop & deliver ethics/compliance related training

Pharmaceutical Cooperation in Healthcare self-commitment organization of the Healthcare Industry

Compliance-support for all departments in pharmaceutical companies for legal topics

Drug advertising law: § 7 (prohibition of donations) as well § 10 and 11 prohibition of public advertising

Codes of the German medical associations / MBO-Ä, Law related to economic offense and competition regulations: HWG (advertising of medicines right), UrhG e-g., Healthcare- Compliance codices and ethical conducts national: FSA-Codex und AKG-Codex, int.: EFPIA, US FCPA

Contract Management

Support-Service, Compliance-Helpline for Project managers and Marketing/Selling teams of Pharmaceutical Companies

Coordinate all aspects of the Global Compliance & Data Privacy Program reporting directly to the Regional Compliance Lead for the EMEAC Region

Coordinate suppliers and vendors activities to achieve full adherence to the Third-Party Due Diligence program

Guide the full implementation of the Global Compliance Program and FCPA by providing insight and offering strategic direction

Execute a robust strategy for the roll-out of a new Global Compliance Tool/ System

Collaborate with the regional team in facilitating regular live compliance training and annual risk-based training to employees and affiliated third parties

Establish and nurture lasting partnerships with business leaders, German employees, and multiple stakeholders by providing compliance guidance and support to various German business and medical teams

Developing an elaborate regional and site compliance & data privacy strategy

Risk-based approach to assess business impact, understand compliance and business drivers, goals and strategies, and advocate for compliance within the business

Coordination of Third-Party Due Diligence program

Supported the company’s corporate strategies of developing and implementing compliance programs, policies, international compliance standards and procedures

Managed risk assessment, investigation, monitoring and audit activities at regional and site level in conjunction with relevant functions, ensuring audit corrective action implementation and monitoring/CSA related improvement action implementation

Regulated and supported the local Compliance Team including management, office, field-based staff and applicable third parties

Conducted local compliance monitoring activities and follow up on improvement actions and compliance audit preparation