based in Kyiv, Ukraine
The Goal :
The goal of this role is to lead the development, implementation, and maintenance of an effective compliance & ethics program to support the organization’s operations.
- Serve as the primary responsible for ensuring that the company adhere to the highest legal, regulatory and ethical standards in all business activities.
- Articulate, design and determine standards of compliance and ethical conduct through the company’s compliance policies and procedures to promote compliance throughout the organization in accordance with all applicable legal, regulatory and industry best practice standards.
- Drive and promote a culture of compliance and ethics across the Company.
- Develop, maintain and continuously improve the Company’s Compliance Program, including the creation, review and revision of policies and procedures to prevent illegal, unethical or improper conduct.
- Play a key role in the Company’s Enterprise Risk Management program, including oversight and coordination of various stakeholders to ensure mitigation of risks.
- Manage the operations of the Compliance Program, including its application to employees and facilities in multiple international jurisdictions.
- Continuously monitor the performance of the Compliance Program and implement methods and controls to improve program effectiveness. Ensure consistency of the program with applicable industry-specific ethics codes and current guidelines from enforcement agencies globally. Advise management on the Company’s compliance with laws and regulations through detailed reports.
- Perform internal audit of the Company to identify potential areas of compliance vulnerability and risk, develop corrective action plans for resolution of any identified issues and implement controls/administer guidance to avoid or deal with similar situations in the future.
- Develop recommendations for new, emerging and/or urgent critical risks or situations that require escalation to executive leadership for awareness and decision.
- Collaborate with leadership throughout the Company to institute and maintain an effective, global compliance communication program, including promoting: (a) heightened awareness of Code of Conduct, (b) understanding of new and existing compliance issues and related policies and procedures, and (c) reporting of compliance related concerns.
- Develop content for and manage the delivery and tracking of employee compliance training to a diverse, global work force.
- Ensure that all compliance concerns or reports of compliance violations are investigated and resolved or properly reported.
- Establish governance mechanisms and procedures that ensure regular and ad hoc compliance updates are provided to the leadership team.
- Design, implement and enhance compliance operations mechanisms to meet the needs of the company as it prepares for commercialization.
- University degree is required, Legal Degree is preferred.
- 3+ years’ experience in international / healthcare compliance in the biopharmaceutical industry, or clinical trials, including building, developing and maintaining comprehensive compliance programs in rapidly-scaling organizations.
- Detailed knowledge of healthcare/ clinical trials, laws and regulations and privacy laws and regulations nationally and internationally.
- Able to apply knowledge and experience to address issues; able to clearly define issues despite ambiguity and take a holistic perspective when making decisions.
- Expertise in all aspects of day-to-day compliance program functions, including development and management of compliance related policies and procedures, reporting systems and controls.
- Advanced interpersonal skills and ability to interact effectively with and influence people at all organizational levels of the Company, including senior management and executive leadership.
- Strong record of integrity, strict confidentiality and experience in advising leadership on sensitive issues.
- Demonstrated experience communicating complex findings and recommendations in a clear and concise manner, both verbally as well as in writing and presentations.
- Knowledge of ICH GCP, FDA GCP Regulations and EU clinical trials directives would be a plus.
- Excellent English proficiency.
The company offers:
- Full-time position in a fast growing business of biotechnology
- Excellent professional and career opportunities
- Open-minded executive management
- Friendly and supportive team
- Intellectually stimulating training from the best providers in the biobanking field
- Fully paid vacation and sick leave
- Medical insurance
- Opportunity to combine work from the office and from home
Qualified candidates interested in this position should send their resume via email to Natalia Sobetska-Koloda, HR Generalist ([email protected])