Amgen Compliance Manager (Adria hub) in Ljubljana, Slovenia
Healthcare Compliance Manager
Promote and support adherence to all Healthcare Compliance requirements (internal and external) in the Country / Countries
Context and Responsibilities
Implement and administeri Amgen's Corporate Compliance programs and policies and EU, EEMEA Compliance standards and Procedures.
Participating in risk assessment, monitoring and audit outcomes. Supporting corrective/ improvement action follow-up in the affiliate.
Identify the need for specific local Compliance procedures; lead/support their development and implementation.
Being the contact point for Healthcare Compliance advice within the affiliate(s)
Interacting with and successfully influencing all levels of staff to accomplish Compliance initiatives and goals.
Understanding Compliance and Business drivers and strategy and being an advocate for Compliance within the business.
Managing the relationship with external translation agencies or trainers.
Balancing physical presence and amount of time dedicated to affiliate and distributor markets according to priorities (if responsible for more than one country).
Representing their country in the Int'l HC Compliance team.
Provide advice, guidance and support to the affiliate staff on interpretation and implementation of regional (e.g. EFPIA) and local Codes of Practice & legislation and Amgen policies and procedures.
Maintain awareness of applicable laws and regulations in the country / countries and keep current with changes that may affect Amgen's Compliance program.
Assist in the implementation of Corporate Compliance programs in the country / countries.
Provide advice, guidance and direction to staff and stakeholders on Amgen's Healthcare Compliance procedures and practices.
Review, translate (if applicable), provide comments and implement regional Healthcare Compliance procedures, presentations, communications and training.
Evaluate the need for, develop and ensure implementation of defined local compliance procedures.
Develop training programs and materials for the local Code and Amgen local procedures.
Deliver Healthcare Compliance training.
Coordinate local Healthcare Compliance training reporting within LMS, perform training tracking and follow-up reminders .
Coordinate meetings with local Compliance committee (3/4 per year - minutes, tracking of assistance, follow up actions) if applicable.
Support/conduct the CRM system annual review in conjunction with local SME and Safety.
Participate in the Compliance audit preparation: set up meetings with each department, prepare documentation request and follow up on audit outcomes.
Conduct local Healthcare Compliance monitoring activities and follow up on improvement actions.
Review (and approve if applicable) local healthcare compliance activities in accordance with local SOPs and the local Code.
Participate in regional compliance initiatives or projects if required.
Serves as local Data Privacy Officer (see slide 2).
Serve as a business partner and core member of the Country Management Team
DPO Privacy and Data Protection Responsibilities - EU
Compliance Manager (Time allocation approximately 15%)Maintains register of processing and Databases
Acts as point of contact for:Data Protection Authority (DPA) Inquiries and Inspections
Data Subject Inquiries (including, but not limited to access requests and requests for correction or deletion)
Data Subject Complaints
Drafts and files Notifications (and Prior Approval Submissions) with local DPA
Facilitates affiliate general manager review and execution of Model Contracts
Supports local PDP activities such as, but not limited to, control self-assessments
Supports the DPO in preparing for Privacy Audits
Supports the DPO and woks with Regional Senior Manager in responding to Data Subject inquiries
Bachelor/ Masters degree in Science or Law
Fluency in English
At least 1-2 years experience in pharma/ biotech business
Compliance awareness/experience at least 1 year
Defining and implementing policies, procedures and SOP's
Developing training materials
Performing healthcare compliance monitoring
Working with cross-functional teams
Knowledge about applicable laws and regulations
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 independently
Awareness of cultural diversity