Amgen Compliance Analyst in Mexico City, Mexico
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
What you will do
Let’s do this. Let’s change the world. In this vital role you will be responsible for:
Assisting the affiliate Compliance Lead, in implementing and administering Amgen’s Corporate Compliance programs & policies and International Compliance standards & Procedures.
Participating in risk assessment and monitoring and supporting corrective/ improvement action follow-up in the affiliate with Regional Director and affiliate Compliance Leads.
Identifying the need for specific local Compliance procedures with the affiliate Compliance Lead, and lead 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 each affiliate according to Priorities. (If responsible for more than one Country)
Providing advice, guidance, and support to the affiliate staff on interpretation and implementation of the local Code of Practice & legislation and Amgen policies & procedures
Maintaining awareness of applicable laws and regulations in the country / countries and keep current with changes that may affect Amgen’s Compliance program.
Assisting in the implementation of Corporate Compliance programs in the country / countries.
Providing advice, guidance and direction to staff and stakeholders on Amgen’s Healthcare Compliance procedures and practices.
Reviewing, translating (if applicable), providing comments, and implementing International Healthcare Compliance procedures and training.
Evaluating the need for, developing and ensuring implementation of defined local compliance procedures together with affiliate Compliance Lead.
Developing training programs and materials for the local Code and Amgen local procedures.
Delivering Healthcare Compliance training.
Coordinating local Healthcare Compliance training within LMS, perform training tracking and flash reminders.
Customizing (and if applicable translate) Healthcare Compliance presentations and communications to local audience.
Coordinating meetings with local Compliance committee (3/4 per year - minutes, tracking of assistance, follow up actions) if applicable
Conducting the CSA annual review. (set up meetings with each stakeholder, support in the implementation and tracking of improvement actions) together with the Compliance Lead
Conducting the CRM system annual review. (a plan for each rep, write the report and conclusions, follow up plan of action)
Participating in the Compliance audit preparation: set up meetings with each department, prepare documentation request etc.
Developing local Healthcare Compliance monitoring activities, conduct monitoring locally With Int’l HC team
Local Healthcare Compliance documents.
Communication and training materials.
Local Healthcare Compliance documents.
Local Healthcare Compliance training.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The hard-working professional we seek would have acquired the knowledge and skills vital to perform the duties of this position through the following combination of education, experience and knowledge equivalent.
At least 2-3 years experience in pharma/ biotech business preferably in a Regulatory or Quality role.
Healthcare Compliance awareness/experience preferred.
Defining and implementing policies, procedures and SOP’s (standard operating procedure).
Developing training materials.
Working with cross-functional teams.
Bachelor/ Masters degree in Law or Science.
Proficient in English.
- Knowledge about applicable laws and regulations.
High level of integrity.
Discreet and able to protect confidential information.
Role model for ethical behavior.
Negotiation, collaboration, persuasion, communication, and relationship building skills.
Investigative and problem-solving skills.
Ability to prioritize.
Ability to work in a highly matrixed organization.
Awareness of cultural diversity.
Availability to travel.
Documentation management Presentation skills.
Ability to work under time pressures.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Apply now for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Amgen does not discriminate in its employment opportunities on the basis of sex, race, color, age, national origin, political or religious ideas, gender, sexual orientation, gender identity, level and type of disability, ethnic origin, or any other category protected by law.
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.