ProClinical is advertising a vacancy for an Associate Director, Ethics & Compliance position with a leading biotechnology company that specialises in RNAi therapeutics.
The organisation uses this innovative form of therapy to treat rare genetic, cardio metabolic, acute hepatic infectious, central nervous system (CNS) and ocular diseases.
The Associate Director will join this company in their office in the UK. This is an exciting opportunity for an experienced and motivated applicant to develop a career in a truly revolutionary field.
Job Responsibilities :
Partnering with employees and country / regional leadership to maintain and further develop throughout the organization a strong culture of ethics and compliance, including personal accountability at all levels in the organization with a spirit of partnership and positive problem solving.
Evolving the Region's current compliance program and ensuring that it is consistent with the values and principles of the organization, fit for purpose, and compliant with applicable requirements.
Drafting and / or updating appropriate policies to ensure compliance with applicable laws, regulations, and industry codes, along with ensuring alignment with global policies.
Supporting the implementation and maintenance of affiliate and regional transparency reporting requirements and assisting business leadership in meeting reporting obligations.
Assisting in implementation and execution of risk based third party due diligence.
Working with colleagues on the implementation of a robust privacy program compliant with EU (GDPR) and Canadian requirements.
Preparing and delivering training and education to ensure understanding of employee responsibilities, ethics, and compliance issues, as well as related policies and procedures.
Executing routine and risk-based monitoring and auditing of relevant business activities and related policies and procedures;
identifying potential areas of compliance vulnerability and risk.
Assisting in and overseeing the implementation of corrective action plans as necessary; generating reports on monitoring, auditing, and risk assessment.
Supporting investigations into allegations of misconduct, as required. Skills and Requirements :
Bachelor's Degree required, preferably in a Legal field, although other relevant accreditations or degrees will be considered.
At least 7 years of ethics, compliance, and / or legal experience in an organization subject to biopharmaceutical, medical device, or other relevant healthcare compliance laws and regulations.
Experience with Transparency reporting a plus
Experience working in multiple EU countries and knowledge of applicable country-specific regulation, as well as foreign healthcare fraud and abuse laws, including the UK Bribery Act, Foreign Corrupt Practices Act, IFPMA, and EFPIA Guidelines.
International biopharmaceutical compliance experience is considered a plus.
Able to thrive in a proactive ethical culture in which compliance and business objectives are mutually reinforcing; strong motivation and ability to champion a comprehensive compliance program that is integrated well with the Company's business and culture.
Significant travel required.
Demonstrable multitasking, project management, and execution skills.
Good interpersonal skills, including communication, presentation, persuasion, and influence.
Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
Proficiency with computer skills, such as MS Office.