Scope : Promotes and supports adherence to all Healthcare Compliance requirements (internal and external) in the Country / Countries
Also serves as country Data Privacy Officer
To the Regional Director or Regional Senior Manager EU / EMEA Healthcare Compliance - direct
Contributing to defining the regional and site compliance strategy to support the business by using a risk based approach to
assessing business impact.
Overseeing, implementing and administering (within the region / site) Amgen’s corporate compliance programs & policies and
International compliance standards & procedures.
Leading / supporting risk assessment, investigation, monitoring & audit activities in the region / site.
Identifying the need for specific local Compliance procedures, leading their development and implementation.
Leading (and in coordination with relevant functions) audit corrective action implementation and Monitoring / CSA related improvement
Understanding Compliance and Business drivers, goals and strategy and advocating for Compliance within the business.
Being the contact point for healthcare compliance advice within the site / region.
Interacting with and successfully influencing all levels of staff in the region / site to accomplish compliance initiatives and goals.
Managing the relationship with external translation agencies or trainers.
Balancing physical presence and amount of time dedicated to each country according to regional and site priorities.
Act as key contact for EU / EMEA regional HCC & represent their region in GCC.
Provides leadership, advice, guidance, direction and support to office, field based staff and applicable third parties on interpretation and implementation of the local Code of Practice & legislation and Amgen healthcare compliance policies, procedures and practices.
Maintains awareness of applicable laws and regulations affecting the site / region and keeps current with changes that may affect Amgen’s compliance program.
Participates in and monitor changes at local Trade Association / local Code Association & in national legislation. Forward relevant information to local teams and regional groups with recommended changes to compliance framework or strategy.
Supports the implementation of Corporate and EU / EMEA Compliance Programs in the site / region.
Conducts local Healthcare Compliance monitoring activities and follows up on improvement actions.
Participates in the Compliance audit preparation : sets up meetings with each department, prepares documentation request, facilitates audit and follows up on audit outcomes.
Supports Corporate Compliance communication strategies and participates in the development of specific communication strategies that will maximize awareness, trust and compliance with Amgen’s business practices, policies and procedures.
Leads / participates in compliance initiatives / projects / expert review team for EU / EMEA Healthcare Compliance.
Reviews, translates, provides comments and implement EU / EMEA Healthcare Compliance procedures and training.
Evaluates the need for, develops and ensures implementation of defined local compliance procedures.
Develops training programs and materials for the local Code and Amgen local compliance procedures and projects.
Delivers Healthcare Compliance training.
Coordinates local Healthcare Compliance training within LMS, perform training tracking and follow-up reminders.
Customizes (and if applicable translate) Healthcare Compliance presentations and communications to local audience.
Leads meetings with local Compliance committee (3 / 4 per year - minutes, tracking of assistance, follow up actions) if applicable.
Together with the finance leads conduct of the CSA (sets up meetings with each stakeholder, supports in the implementation and tracking of improvement actions).
Conducts local Healthcare Compliance monitoring activities.
Reviews (& if applicable approve) local healthcare compliance activities in accordance with local SOPs and the local Code.
Supports / conducts the free text field’ review (if required).
Participates in regional compliance initiatives or projects.
Bachelor / Masters degree in Science or Law
Fluency in English
Additional languages preferred
At least 5 years experience in pharma / biotech business
2-3 years compliance related experience preferred
2-3 years in development function preferred
Defining and implementing policies, procedures and SOP’s
Working with cross-functional teams
Developing training materials
Knowledge about applicable laws and regulations preferred
Subject matter knowledge
Negotiation, collaboration, persuasion, communication and relationship building skills
Highest level of integrity
Discreet and able to protect confidential information
Role model for ethical behavior
Investigative and problem solving skills
Ability to work in a highly matrixed organization
Awareness of cultural diversity
Personal and professional maturity
Self leadership / motivation
Ability to work independently
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win.
Together, we live the Amgen values as we continue advancing science to serve patients.