Compliance Specialist
Duchnice
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Your responsibilities:
- Supporting the Compliance Officer in local management in developing strong compliance mindset, putting in place a comprehensive compliance program and the necessary procedural infrastructure;
- Supporting the CO in establishing and setting the tone of compliance throughout the Company;
- Supporting the CO in defining the necessary level of knowledge on existing and emerging regulatory compliance requirements;
- Supporting CO in creation and periodical review of the company compliance program plan and ensuring its execution;
- Supporting CO in managing and executing policies and procedures, which govern the Group compliance program;
- Networking and collaborating with other compliance experts in the company;
- Supporting CO in caring out risk assessments and compliance reviews to ensure policies and procedures are being followed;
- Monitoring and testing policies and procedures to ensure they result in compliance;
- Recommending the initiation of investigative procedures in response to alleged violations of the law, policies, procedures, and the Code of Conduct and other relevant regulations;
- Taking part in providing guidance on the effective response to detected problems and proper recommendations for corrective action as appropriate;
- Taking part in carrying out periodic evaluation of the company compliance programs and proposing appropriate changes and improvements that reflect the company’s unique characteristics;
- Taking part in preparing and presenting clear and concise compliance reports for the Management, including documenting all business ethics incidents with status and steps taken to address them and the progress made;
- Risk Management – in cooperation with risk management and business continuity function, contribute to business continuity process;
- Supporting CO in building and maintaining the compliance mindset in the organization, ensure that all employees are properly trained, and aware how they should raise the compliance questions;
- Taking part in governing the responsibility to report misconduct and noncompliance, reporting pathways and ensuring the implementation of non-retaliation policies;
- Supporting CO in monitoring external audits, investigations and review processes as well as leading and conducting internal reviews and investigations;
- Liaise with legal and regulatory bodies on compliance-related issues;
- Taking part in providing guidance, advice, and training programs, to improve understanding of law, policies, procedures, and the Code of Conduct and other relevant regulations and participating in relevant Committees;
- GDPR Compliance.
If you have:
- Master’s degree (required): preferably in law, risk management, finance or a related field;
- 2 - 5 years of compliance experience required; preferably with legal, audit, risk management or finance;
- Experience in the medical, pharmaceutical, or life sciences industry will be an asset;
- Knowledge and skill requirements/specialized courses and/or training. Comprehensive knowledge of laws/regulations applicable to a global healthcare company;
- Proficient in Polish and English;
- Good interpersonal influencing and negotiation skills, and proven ability to communicate and work with all levels of the organization;
- Critical thinking skills; ability to work through complex issues, including those with significant strategic risk to the company;
- Proficiency in business software (including Microsoft Office) and compliance management tools.