This position will support Frenova Renal Research and Renal Research Institute within the Global Medical Office mainly in EMEA. Regulatory or Clinical Research compliance experience is preferred.
Position Purpose:
Oversees and drives the operational development, implementation and maintenance of all aspects of a robust global compliance program, i.e. resources, policies, procedures, templates, trainings, controls, monitoring and respective support by technical instruments. Fosters and drives adequate levels of transparency regarding the status of the compliance program including potential compliance risks, mitigating actions and status of their implementation on a need-to-know basis for supervisory board, management board as well as other stakeholders internally and externally. Advises in compliance related topics and steers the coordination of global compliance initiatives.
Primary Duties:
Global Compliance Program
- Independently supports in the further development of the Global Compliance Program, including optimization of processes, procedures, policies, training etc. and allocates available resources effectively and efficiently
- Independently supports the implementation of compliance instruments such as processes, procedures, policies, training, IT-tools on a global level regarding area of responsibility
- Independently supports in monitoring of regulatory developments and adaption of Global Compliance Program accordingly, e.g., attending events, associations and doing research
Projects and Operations
- Independently supports the performance of all relevant projects and ongoing operations regarding scope, timeline for area of responsibility
- Independently supports in the maintenance and development of instruments for communication of compliance-relevant content; maintains and develops communication platform content (e.g., intranet) and processes for document management
- Independently supports the management of compliance-related IT-operations and infrastructure in close cooperation with the respective IT-departments for the [rea of responsibility
- Proactively participate and contributes to relevant compliance and investigation training, networks and other respective educational activities to further professional development in consultation with supervisor
- Independently supports the implementation, design, maintenance and further development / improvement of a framework which enables the compliance function to monitor, regularly assess, improve and ensure risk orientation of the compliance management system with all relevant aspects regarding area of responsibility, e.g., policies and procedures, training framework and respective training content, communicative instruments ( e.g., intranet, newsletters), control framework and design of relevant first and second level controls, monitoring of business and corporate transactions, processes, structures, relations as well as external developments, regular and ad hoc reporting framework
- Independently supports monitoring, analyzing, assessing and recording of business and corporate transactions, processes, structures, relations as well as external developments with regard to identifying compliance risks related to area of responsibility, designing mitigating actions and tracking the respective status in the framework of compliance risk management related to area of responsibility
- Independently supports the identification of information, which needs to be communicated to all relevant Compliance Departments and proposes actions for a sound collaboration in between all Compliance Departments
- Proactively supports and contributes to project work
- Proactively takes on additional tasks in consultation with the respective supervisor
- Additional tasks in consultation with the respective supervisor
Reporting and Collaboration
- Reports regularly and ad hoc to supervisor with respect to area of responsibility
- Independently supports in ensuring a regular and ad hoc information flow for a sound collaboration within the Global Compliance Department with respect to area of responsibility
- Conducts regular reporting to internal and external stakeholders in alignment with supervisor / project manager
Additional Tasks
- Support and management of Global Medical Office related matters.
Qualifications:
- Master degree or equivalent qualification in Business, Economics, Law or similar specialization is beneficial
- Certifications such as CCP are beneficial
- Minimum of 6 years of general professional experience, of which a minimum of 4 years of operational experience in the field of Compliance / Risk Management, Regulatory, preferably in the healthcare industry, is beneficial
- International experience is desired
- Strong interpersonal, communication, intercultural, collaboration, change and project management, presentation / moderation, action orientation / problem solving skills, as well as the ability to deal effectively with all levels of an organization
- Strong result driven attitude
- Strong apprehension and fast familiarization with new and complex tasks
- Strong analytical skills and judgment
- High degree of integrity, confidentiality, trust and accountability
- Strong self and time management
- Good negotiation and mediation skills as well as confidence to handle difficult conversations, pressures and deadlines
- Ability to integrate oneself in a team environment
- Sound Leadership skills, e.g. motivation, team building, talent development, visionary leadership
- Sound ability to make qualitative decisions and think creative
- Good organizational savvy, e.g. processes and politics
- Solid degree of flexibility, e.g. willingness to travel or situational adaptability
- Fluency in English and the language locally spoken
- Solid command of MS-Office and ability to adapt new technologies
- Willingness to travel
Poland
