Amgen Compliance Manager (Adria hub) in Ljubljana, Slovenia

Healthcare Compliance Manager

Purpose

Promote and support adherence to all Healthcare Compliance requirements (internal and external) in the Country / Countries

Context and Responsibilities

Responsible for:

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.

Key Activities

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

Privacy Audits

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

Qualifications

Bachelor/ Masters degree in Science or Law

Fluency in English

Experience

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

Knowledge about applicable laws and regulations

Key Competencies

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

Multi-tasking

Ability to work independently

Awareness of cultural diversity