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 cutting-edge 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
Independently author routine to moderately complex documents, including:
ICFs and ICF amendments
PLPS and Amendments
Sections of CSRs (synoptic, abbreviated and standard; pivotal CSRs with support)
Protocol Amendments and Country Specific Protocol Supplement
IB updates (minor / focused updates)
Manage document versions, reviewer comments, and approval flows end to end for assigned documents.
Ensure assigned documents are scientifically accurate, consistent across sections and aligned with source data and program intent




Prepare documents to be QC and inspection ready, adhering to Guidance documents/SOPs
Support audits or inspections by providing documentation history and rationale when needed.
Engage with Clinical, Safety, Regulatory and Study teams to clarify inputs, resolve comments and incorporate feedback efficiently
Participate in document related meetings as required.
Escalate risks, scope changes, or timeline pressures early to Managers.
Track assigned deliverables and timelines.
Participate in internal trainings, KT sessions, and process improvements.
Consistent on time delivery

Collaboration Skills:
Cross-functional stakeholder management
Communication and presentation skills
Negotiation and conflict resolution
Strategic thinking and decision making
Ownership and accountability

. Project Management & Operational Skills
Timeline planning and execution
Managing multiple deliverables simultaneously
Risk ide

📌 Seniorr Associate Regulatory Writing Hyderabad
🏢 AMGEN
📍 Hyderabad