Leading Biopharma M/N requires a Commercial Assurance Manager (Ethics) to join their Finance Team based in Dublin.
- Ensure best in class affiliate commercial compliance in partnership with the Compliance Steering Committee (CSC) and where applicable, with guidance & partnership from the Office for Ethics and Compliance (OEC) on work supporting the Affiliate Ethics & Compliance Program, to support the organisations commercial operations in Ireland.
- Provide compliance oversight on proposed affiliate programs, tactics and strategies, identifying basic legal, regulatory or other relevant issues and propose solutions to the business, informing & where necessary, consulting with OEC.
- Work in partnership with all affiliate personnel to drive a culture of high compliance and ensure all company activities are conducted within the framework of the Code of Business Conduct, the IPHA Code of Practice and applicable laws.
- Provide GDPR support to Data Protection Liaison in delivering affiliate data protection program.
- Work with both purchasing and legal teams with vendor contract management program.
- Provide guidance and support to affiliate personnel on national industry codes and regional/international industry codes, government regulations and the organisations specifics policies.
- Perform compliance risk assessments, trend analyses and provides and implements best practices recommendations.
- Implement, manage and interprets compliance policies, procedures and practices.
- Create local SOPs and job aids (where applicable) to support seamless execution of activities at the affiliate level.
- Participate in Grants and Donations oversight committee and review of same.
- Develop, implement, and coordinate awareness, education and training programs that focus on the elements of the Code of Business Conduct, policies and procedures and applicable industry codes and regulations.
- Lead the affiliate in compliance audits and external inspections (e.g. HPRA), overseeing the fulfilment of auditors' or inspectors' requests, acts as liaison between business and auditors during on-site activities, evaluates and responds to all basic and routine preliminary findings and recommendations, guides the business in preparing corrective action to address ...
- Bachelor degree required in a field such as Quality, Finance, Legal or Audit or 5 to 7 years' relevant work experience strongly preferred
- Ability to work in cross-functional teams with strong analysis and problem-solving skills
- Strong verbal and written communication, including fluent command of English
- Strong negotiation/influencing and decision-making skills
- Demonstrated capabilities to adapt to variety of situations/scenarios and strong counselling abilities
- Customer orientation
- Ability to meet tight timelines
- Ability to build and maintain collaborative relationships in matrixed work environment
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