Career Category
Regulatory
Job Description
ABOUT AMGEN
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver creative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

Roles & Responsibilities
Writes and edits non-complex regulatory documents (eg, easy clinical study report, investigator brochure, protocol, protocol amendments, Plain Language Protocol Synopsis, Plain Language Summary) and easy standalone documents (eg, informed consent forms and amendments)
Participates in collaborative team activities for non-complex documents, including support to collect input from authors/reviewers
Participates in the cross-functional document review process, comment triage, meeting attendance,



and incorporation of feedback for development of subsequent drafts or for finalization
Generates appropriate in-text tables and figures
Manages the development of regulatory documents, ensuring compliance with guidelines and timelines; collaborate with Project Teams to track progress, facilitate reviews, and ensure documents meet regulatory standards for submission.
Learns and uses organizationally required authoring tools and technology platforms
Attends cross-functional meetings with other writers and departments, as appropriate, to share and gather information relevant for successful completion of their own and inter-dependent projects
Documents in scope include, but are not limited to: Clinical Study Reports, Observational Research Study Reports, Plain Language Summaries, Investigator Brochures, local Risk Management Plans, non-complex Original Protocols/ Protocol Amendments, and ICFs.
Understands and complies with SOPs, templates, best practices,

📌 Senior Associate Regulatory Writing Hyderabad
🏢 AMGEN
📍 Hyderabad