Regulatory Affairs Sr Manager, Regulatory Promotion & Material Compliance
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Job Description
Career Category Regulatory Job Description Join Amgen ’s Mission of Serving Patients At Amgen , if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year.
Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.
As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based.
If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Regulatory Affairs Sr Manager, Regulatory Promotion & Material Compliance What you will do Let’s do this.
Let’s change the world. In this vital role you will provide strategic direction for product and disease communications and activities by interpreting current FDA regulatory environment to ensure truthful and non-misleading communication to health care community, patients, and the public.
This position is primarily responsible to formulate and communicate the regulatory promotional position for approved and/or pipeline products.
Key Responsibilities
Promotional review committee experience in evaluating proposed pieces and supporting evidence Evaluate promotional enforcement activities and assess the changing regulatory environment to determine impact on Amgen Update the Promotions group on new learning’s and key takeaways from c
Required Skills
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