Let’s make a difference together. In this essential role, you will be responsible for authoring various regulatory submission documents, including but not limited to:
You will conduct formal reviews and approvals of authored documents in accordance with our standard operating procedures. Under supervision, you will manage regulatory writing activities for product submissions, including new and supplemental drug applications/biologics license applications.
As a functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group), you may provide valuable input for the Global Regulatory Plan and team objectives. You might also collaborate with contract and freelance writers and participate in training and mentoring junior medical writers.
In addition, you will help generate document timelines with team input and stay informed about relevant professional information and technology.
We value individuality and unique contributions in our mission to serve patients. The ideal candidate for this role is someone with:
Functional Skills:
Soft Skills:
At Amgen, we’re dedicated to your professional and personal growth. From competitive benefits to a collaborative culture, we support your journey every step of the way. Our comprehensive Total Rewards Plans align with local industry standards, in addition to your base salary.
Embark on a career that defies imagination. The opportunities in your future are closer than they appear. Join us.
careers.amgen.com
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Ranchi |Karnataka :
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Banasthali | Jaipur | Pilani | Udaipur |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |Uttarakhand :
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Remote | Remote, USA | Remote - Europe | Switzerland |Makkah :
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