Posted BY
AmgenCareer CategoryComplianceJob Description 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 Join Us 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. . .
Hi! How can we help you?
Click below button to start chat