Pharmathen is one of the leading complex drug delivery and formulation developers and is among the top 50 pharmaceutical research companies in Europe. Driven by innovation, the company specializes in one of the most modern and technologically innovative sectors, developing Long Acting Injectables (LAI), Sustained Release formulations and Preservative Free Ophthalmics.
Pharmathen’s portfolio consists of over 100 products, produced at its facility in Sapes, Rodopi, approved by the US Food and Drug Administration (FDA), and at its modernized production unit in Pallini, Attica.
Pharmathen is one of the largest private investors in research and development in Greece, with steady investments of €35 million annually in the R&D sector and employs over 1,350 people from over 24 different nationalities. The company's enduring success is attributed to the passion for creativity, the ethics, and dedication of its people, who share the company's vision of making a difference in people’s lives.
Due to continuous growth and expansion, Pharmathen Pharmaceuticals offers a great opportunity for career development and is seeking to recruit a Compliance & Ethics Expert for the Legal, Compliance & Intellectual Property / ESG department in our Maroussi premises.
As a Compliance & Ethics Expert the ideal candidate will ensure that the organization operates in accordance with the applicable legal and regulatory framework. He/she will identify and manage compliance risks, implementing compliance programs, and promoting a culture of ethical conduct and adherence to legal requirements within the company, provide guidance on regulatory matters, develop and maintain compliance policies and procedures.
He/she will be responsible for embedding compliance & ethics as an integral part of the Group Sustainability Strategy addressing internal operations as well as the company’s value chain upstream and downstream, setting the appropriate objectives for Management approval and seeing to their attainment in cooperation with involved stakeholders.
More particularly:
Requirements
What you will do:
- COMPLIANCE PROGRAM - Work closely with the legal team to develop and implement an effective compliance program that aligns with industry best practices, laws, and regulations. Develop the Policies and Procedures that define and enhance the compliance program and ensure that they are effectively cascaded across the Group with the appropriate IT tools. Ensure that the objectives of the compliance program align with the Group Sustainability Strategy
- LEGAL & REGULATORY FRAMEWORK - Monitor changes in laws, regulations, and guidelines related to the pharmaceutical industry and assess their impact on the company's operations, provide guidance and advice to relevant stakeholders on compliance matters and assist in obtaining necessary licenses, permits, and approvals
- COMPLIANCE RISKS - Conduct regular assessments to identify potential compliance risks within the organization, evaluate existing policies, practices, and procedures to ensure compliance with applicable laws and regulations and develop strategies and controls to mitigate identified risks. Update Risk Assessments, ensuring that corporate developments are effectively accounted for. Cooperate with Enterprise Risk Management to ensure that material compliance risks are effectively accounted for and controlled under the Corporate Risk Landscape
- COMPLIANCE TRAINING - Develop and deliver compliance training and awareness programs to educate employees on legal and regulatory requirements, industry standards, and company policies and create and maintain training materials, including online modules, presentations, and workshops, to ensure employees have a clear understanding of compliance obligations
- Cooperate with Human Resources and Corporate Communications & Engagement for promoting a culture of ethics and integrity within the organization. Prepare and communicate reports on training intake by employees
- GRIEVANCE - Ensure the operational effectiveness and conformance to applicable standards for the processes related to stakeholder grievance mechanisms related to compliance & ethics (such as whistleblowing). Support the proper flow of information to the appointed recipients for incident management
- COMPLIANCE EFFECTIVENESS - Establish and implement monitoring procedures to assess compliance with company policies and legal requirements, conduct periodic compliance audits, review documentation, ensure adherence to established protocols, identify areas for improvement and recommend corrective actions. Ensure effectiveness and appropriateness of compliance tools in use (screening platforms, policy platform, risk assessments, compliance files, contract reviews etc). Introduce and implement the appropriate management systems (ISO) necessary for ensuring the effectiveness of compliance and ethics processes, in line with prevailing international standards
- DISCLOSURES - Prepare and submit timely and accurate reports to regulatory authorities and other supervisory bodies, as required, maintain comprehensive records of compliance activities, including policies, procedures, training records, investigations, and corrective actions and ensure compliance documentation is organized, accessible, and up to date. Provide accurate data for reporting obligations to Board committees and Shareholders. Support the preparation and response to questionnaires related to ESG Ratings and ad-hoc requests
- VALUE CHAIN COMPLIANCE – Ensure the effectiveness of controls engaged for the Compliance & Ethics screening across the value the chain (upstream and downstream), including but not constrained to the following:
- Screening of suppliers / Human & Labor Rights / Code / Sanctions / Due Diligence exercises
- Screening of customers / Sanctions / particular CROs controls for debarment & animal testing
- SUSTAINABLE PROCUREMENT – Cooperate with Strategic Sourcing / Procurement (direct and indirect) for establishing and effectively operating sustainable procurement practices in line with international standards (ISO), including but not constrained to activities below:
- ESG Criteria for Tenders
- ESG requirements embedded into Supply Contracts
- Sustainable Procurement Policies and Procedures in cooperation with involved internal stakeholders
- COMPLIANCE GUIDANCE & SUPPORT - Collaborate with cross-functional teams to provide compliance guidance and support, participate in meetings, projects, and initiatives to ensure compliance considerations are integrated into business processes and decision-making
The ideal candidate should have:
- Bachelor's degree in law, business, or a related field – a master’s degree is preferred
- 5 - 8 years of relevant experience in a compliance role in a corporate setting, preferably within the pharmaceutical industry or a highly regulated environment
Job-Specific Skills:
- Excellent communication in English language (writing & speaking)
- Preferred knowledge of pharmaceutical regulations, such as FDA regulations, Good Manufacturing Practices (GMP), Good Clinical Practice (GCP), and other relevant industry guidelines
- Strong understanding of legal and compliance frameworks, including Anti-Bribery and Anti-Corruption laws (FCPA), and privacy regulations
- Strong understanding and/or experience of procurement practices including tenders, contracts and due diligence.
- Familiarity with compliance program development, risk assessments, and internal investigations
- Excellent understanding / experience with corporate-wide strategy programs with setting of targets and milestones and cross-company cooperation for attainment.
- Excellent analytical skills and attention to detail, with the ability to interpret complex regulations and apply them to practical situations
- Strong professional interest in connecting compliance and ethics with wider ESG objectives
- Strong communication and interpersonal skills, with the ability to collaborate effectively across departments and influence stakeholders at all levels
- Ability to handle confidential information with discretion
Benefits
What you'll gain:
- Involvement in a high-caliber, team-oriented and dynamic atmosphere
- Exposure to challenging business issues and practices
- Great opportunity to leverage and develop your business knowledge and skills
Join our team and experience the unique Pharmathen’s culture that gives you the opportunity to innovate, to make decisions, to achieve your own potential and to chart your own career.
Pharmathen is an equal opportunity employer. We welcome applications regardless of gender, race, age, religion, sexual orientation, and national origin.
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Last updated on Apr 19, 2024