Director Global Regulatory Writing

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. Join us.

• Prepare and oversee the review and approval of scientific and regulatory submission documents.
• Serve as functional area lead on product teams.
• Maintain key business relationships with cross-functional product team members and appropriate management staff across the Amgen R&D organization.
• Provide expertise and guidance on document design and principles of good medical writing to individual staff, the department, product teams, and other functional areas.
• Supervise, train, coach, and mentor regulatory writers.
• Oversee the work of contract writers and CROs assigned to program documents.
• Manage and implement day-to-day departmental activities and operations, including hiring; resourcing projects; leading or participating in cross-functional process development, training, and oversight; business process ownership; and meeting management.
• Assist executive leadership with resource and budget planning and other department management activities, as needed.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Regulatory Writing professional we seek is a leader with these qualifications.

Required experience includes :

The successful candidate will have the following skills :

Skills Required

Clinical Research, Project Management, clinical development, Scientific Writing, Editing