Global Regulatory Writing Manager
Amgen(1 year ago)
About this role
A Regulatory Medical Writer who partners with cross-functional product teams to author and review regulatory submission documents and support product submissions. The role may serve as a functional area lead on product teams, manage regulatory writing activities with supervision, and mentor junior writers while participating in departmental initiatives.
Required Skills
- Regulatory Writing
- Document Review
- Project Management
- Clinical Development
- Microsoft Office
- SOP Compliance
- ICH
- GCP
- Mentoring
- Communication
Qualifications
- Doctorate Degree
- Master's Degree (4-6 years related experience)
- Bachelor's Degree (6-8 years related experience)
- Diploma (10-12 years related experience)
About Amgen
amgen.comAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
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