Compliance Sr Mgr
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.Live
What you will do
Lets do this! Lets change the world!
Assess and manage risk, including providing input into the development of the annual audit program
Collaborate with other Amgen compliance/quality functions to ensure aligned and comprehensive compliance support for R&D, GPvP and labelling
Participate as compliance representative in evaluating, qualifying and providing oversight of GPvP and labelling vendors
Participate in due diligence activities for potential business development deals
Ensure proactive identification, escalation to appropriate compliance/quality oversight bodies and participate in compliance investigations and management and remediation of compliance issues relating to processes, programs and external relationships
Prepare, analyze and communicate compliance metrics (e.g., audit and inspection data) and other significant compliance information on periodic basis to key partners and senior R&D management
Maintain knowledge of current regulatory and compliance practices/issues , aassess changes in new regulations and the external environment and advise partners accordingly
Triage and/or manage as appropriate R&D/GPvP/labelling compliance matters arising in assigned geographic region
Support activities related to inspections - preparation, conduct and close out and response review
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.Experience
Doctorate degree and 2 years of biopharmaceutical industry experience
Masters degree and 6 years of biopharmaceutical industry experience
Bachelors degree and 8 years of biopharmaceutical industry experience
Associates degree and 10 years of biopharmaceutical industry experience
High school diploma / GED and 12 years of biopharmaceutical industry experience
Minimum 7 years in biopharmaceutical industry
Minimum 5 years in GPvP/labelling compliance
Experience supporting regulatory authority inspections of pre-clinical, clinical research, and/or pharmacovigilance activities
Compliance program or project management
Participation in process improvement initiatives
Leadership or mentoring experience
What you can expect of us
As we work to develop treatments that take care of others, so we 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
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com#Operations21Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Join UsIf 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.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.