Amgen Compliance Lead in Risch-Rotkreuz, Switzerland

Amgen is one of the world's leading independent biotechnology companies. For nearly 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.

We are currently seeking a Compliance Lead to join our team in Switzerland. The main purpose of the job is to promote and support adherence to all Healthcare Compliance requirements in Switzerland and to serve as country Data Protection Officer.

MAIN TASKS AND RESPONSIBILITIES:

  • Implementing and administering Amgen's Corporate Compliance programs and policies and EU/MEA Compliance standards and Procedures

  • Providing risk assessment and periodical monitoring on business activities

  • Publishing EFPIA report on Swiss Amgen website, managing corrections or adjustments if necessary

  • Leading (in coordination with local business) implementation of corrective/ improvement actions and follow-up in the affiliate with Regional Compliance Team

  • Participating in internal audit and leading (in coordination with local business) implementation of corrective actions

  • Being the contact point for Healthcare Compliance advice within the affiliate

  • 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

  • Maintain awareness of applicable laws and regulations in the country and keep current with changes that may affect Amgen's Compliance program

  • Review, provide comments and implement International Healthcare Compliance procedures, presentations, communications and training

  • Member of the cross functional affiliate management team (actively contributing to and participating in healthcare compliance related discussions)

  • Coordinating and leading implementation of all relevant rules and guidelines regarding Privacy at the site/affiliate

  • Identify Privacy related risks and gaps based on local legal environment, developments and projects

  • Preparing for Privacy Audits and addressing any privacy findings in a timely manner

QUALIFICATIONS:

  • Bachelor/ Masters degree in Law or Science

  • Fluency in English and German/Swiss German is a must

REQUIREMENTS:

  • At least 2-3 years experience in pharma/ biotech business preferably in a Regulatory or Quality role

  • Healthcare Compliance awareness/experience preferred

  • Data Privacy awareness/experience preferred

  • Knowledge about applicable laws and regulations preferred

  • Defining and implementing policies, procedures and SOP's

  • Developing training materials

  • Working with cross-functional teams