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Associate Director Training, Global Compliance & Ethics

Location Dublin, Ireland
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

By providing a foundation for all operations company wide, BioMarin’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.

Summary Description

The Associate Director Compliance Training and Systems, under the direction of the Executive Director, Head of Europe Middle East and Africa (EUMEA) Compliance, will facilitate the development of a training strategy to ensure that all BioMarin stakeholders both internal and external are trained on all areas of Healthcare Compliance to the highest ethical standards.  In particular, the role is responsible for ensuring that EUMEA management and employees are trained on the rules and regulations of regulatory agencies, company policies and procedures and the company’s Standards of Conduct, as outlined in the Global Code of Conduct and Business Ethics. 

The successful applicant will bring strong training and development knowledge, coaching skills, and business acumen to develop and advance the current training approach into a comprehensive, robust compliance training programme. To be successful, this applicant must be highly motivated, and a self-starter with a can-do attitude able to execute on a full complement of duties—from tactical to strategic, taking a pragmatic approach.

Foreign travel will be required in this role from time to time as required, with more frequent travel to London.


Responsibilities

  • Lead the development, implementation and maintenance of a robust training programme to embed compliance policies and procedures for the general operation of the Compliance Programme and its related activities to prevent illegal, unethical, or improper conduct, specifically:

  • Programme Design: Perform a full assessment of training requirements across the business. Design, develop and roll out  a comprehensive programme of compliance training for all parts of the business including commercial, brand management, market access and clinical teams.
  • Training Delivery: Delivery of courses through a variety of media, including face to face seminars and workshops; eLearning and remotely, on both a rolling and an as-needed basis in EUMEA
  • Asset Maintenance: Maintain current content assets including interactive resources, and redesign/manage as necessary in consultation with Executive Director EUMEA Compliance. Commission/design new assets as may be required to meet the needs of the business.
  • Asset Deployment/Course Records: Deployment of Assets via BioMarin LCD portal or other means as may be desired. Maintenance of course records in line with Compliance needs. 
  • Workshop Design and Delivery: Partner with the Business stakeholders as required to design and deliver suitable workshops for Area, Country or Zone Meetings on topics identified as appropriate.
  • Periodically input into the review and update of regional corporate business policies to ensure continuing relevance in providing guidance to management and employees based on feedback from training and stakeholder understanding;
  • Collaborate with other company functions, including, but not limited to Commercial Operations, Medical Affairs, Clinical and Regulatory Affairs to provide training regarding potential compliance issues and risks;
  • Remain current on external legal and compliance trends in the biopharmaceutical industry to identify potential areas of compliance vulnerability and risk.

Education:
  • A Bachelor’s degree is required; a law degree would be an advantage
  • Demonstration of In Role Development Training Qualifications
  • ABPI Exam
  • Clear knowledge of the ABPI and EFPIA codes


Experience:

  • A minimum 3 years of experience practicing law or working in the pharmaceutical/healthcare compliance field.
  • Experience with and/or understanding of corporate compliance issues confronting the pharmaceutical, biotechnology, and/or healthcare industry generally.
  • Demonstrable knowledge and understanding of the legal and regulatory framework affecting the pharmaceutical/biotechnology industry; including, but not limited to, sales and marketing fraud and abuse issues and other industry guidance documents, EU country regulations on the promotion of marketed products, clinical trial regulations, and issues arising under the Anti-bribery and Anti-corruption global law
  • At least two years’ prior experience of responsibility for designing and delivering compliance training from wing to wing is essential, with a high level of healthcare compliance knowledge.
  • Demonstrable effectiveness operating in complex organisational and regulatory environments.
  • Experience of working in cross-functional teams at the European level and an ability to partner effectively with others in a matrixed organisation to ensure complex issues are addressed is preferred.
  • High level of competency with Microsoft Office Suite is mandatory.
  • Very high level of Powerpoint and Excel preferred.
  • Microsoft One Drive and other Sharepoint Systems experience necessary.
  • Experience of Job Bagging Systems (Veeva etc) preferred (training will be provided).
  • Experience of Learning/Content Management Systems preferred (training will be provided).
  • Strong persuasive skills and sound business judgment.
  • Motivated, self-starter with ability to appropriately prioritise issues and allocate resources. Sound project management skills.

Work Environment:

Must be willing to work in a team environment and be able take direction from multiple stakeholders. Must be willing to travel, including internationally, both as needed and regularly.  Travel may fluctuate, but on balance will be between 20% and 30%. 



We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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Dublin

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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