Seniorr Associate Regulatory Writing

Amgen; Hyderabad; On-site; INR 900,000 - 1,500,000; Full time

Benefits offered by this job

SharePoint access

RIM tools training

Job summary

Amgen in Hyderabad, India is seeking a regulatory document writer to independently author routine to moderately complex documents including ICFs, CSRs, protocol amendments, and IB updates. You will manage document versions, ensure scientific accuracy, align with source data, and prepare materials for QC, audits and inspections.

Collaboration with Clinical, Safety, Regulatory and Study teams is essential to resolve inputs and feedback.

Qualifications

• Independently author routine to moderately complex regulatory documents (ICFs, amendments, CSRs, IB updates)
• Ensure documents are scientifically accurate and aligned with source data
• Prepare docs for QC and inspections per SOPs/guidance
• Coordinate inputs with Clinical, Safety, Regulatory and Study teams
• Track deliverables and timelines

Responsibilities

• Author routine to moderately complex documents (ICFs, amendments, CSRs, Protocol Amendments, IB updates)
• Manage document versions, reviewer comments and approvals end to end
• Ensure scientific accuracy and alignment with source data and program intent
• Prepare documents for QC and inspection readiness
• Assist audits/inspections with documentation history and rationale
• Engage with cross-functional teams to clarify inputs and incorporate feedback
• Participate in document-related meetings and escalate risks early
• Monitor timelines and deliverables; contribute to process improvements
• Maintain consistent on-time delivery

Skills

Cross-functional stakeholder mgmt

Communication & presentation

Negotiation & conflict resolution

Strategic thinking & decision making

Ownership & accountability

Project management & operations

Timeline planning & execution

Managing multiple deliverables

Risk identification & mitigation

Review coordination & comment handling

Document management systems (RIM,Share

Tools

SharePoint

RIM tools

Document authoring platforms

Job description

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 innovative 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 identification and mitigation
• Review coordination and comment resolution
• Working effectively with document management systems, RIM tools, SharePoint, and authoring platforms

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.