Global Regulatory Writing – Senior Associate

Overview

Independently author routine to moderately complex regulatory documents for Amgen's global regulatory writing function, managing them end-to-end through review and approval.

What you'll do

• Independently author routine to moderately complex regulatory documents, including ICFs and ICF Amendments, PLPSs and PLPS Amendments, CSR sections (synoptic, abbreviated, and standard reports; pivotal CSRs with guidance/support), PLS, Protocol Amendments and Country-Specific Protocol Supplements, and IB updates (minor/focused updates).
• Manage document versions, reviewer comments, and approval workflows end-to-end for assigned documents.
• Ensure assigned documents are scientifically accurate, internally consistent, and aligned with source data and program objectives.
• Prepare documents that are QC-ready and inspection-ready, adhering to applicable guidance documents, SOPs, and regulatory requirements.
• Support audits and inspections by providing document history, supporting documentation, and justification/rationale as required.
• Collaborate with Clinical, Safety, Regulatory, and Study teams to clarify inputs, resolve comments, and efficiently incorporate feedback.
• Participate in document-related meetings, as required.
• Proactively escalate risks, scope changes, and timeline challenges to managers.
• Track assigned deliverables and ensure adherence to agreed timelines.
• Participate in internal training programs, knowledge-transfer sessions, and continuous process improvement initiatives.
• Demonstrate consistent, on-time delivery of assigned deliverables.

What you'll need

• Master's degree and 5 to 8 years of directly related experience.
• Cross-functional stakeholder management.
• Effective communication and presentation skills.
• Negotiation and conflict resolution.
• Strategic thinking and decision-making.
• Ownership and accountability.
• Timeline planning and execution.
• Managing multiple deliverables simultaneously.
• Risk identification and mitigation.
• Review coordination and comment resolution.
• Proficiency in document management systems, RIM tools, SharePoint, and document authoring platforms.

Details

• Location: Hyderabad, India.