Global Regulatory Writing – Senior Associate

Amgen; Hyderabad; Sur place; INR 1 200 000 - 2 200 000; Plein temps

Résumé du poste

Amgen seeks a Regulatory Documentation Specialist to independently author routine to moderately complex regulatory documents (ICFs, CSR sections, amendments) and manage end-to-end review workflows. You will ensure scientific accuracy and alignment with program data, while preparing QC-ready and inspection-ready materials.

Collaborating with Clinical, Safety, Regulatory, and Study teams, you will address comments, track deliverables, and support audits/inspections with thorough documentation

Qualifications

• Master’s degree and 5 to 8 years of directly related experience.
• Experience authoring regulatory documents (ICFs, CSR sections) and managing document workflows.

Responsabilités

• Independently author routine to moderately complex regulatory documents (ICFs, CSR sections, amendments).
• Manage document versions, reviewer comments, and approval workflows end-to-end.
• Ensure documents are scientifically accurate and aligned with data and program objectives.
• Prepare QC-ready and inspection-ready documents per guidance and SOPs.
• Support audits and inspections with documentation history and rationale.

Connaissances

Cross-functional stakeholder mgmt

Effective communication

Negotiation

Project management

Timeline planning

Risk identification

Review coordination

Document management systems

SharePoint

RIM tools

Formation

Master’s degree

Outils

SharePoint

RIM tools

Document authoring platforms

Document management systems

Description du poste

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 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.

Key Responsibilities

• 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, 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 escape 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.

Collaboration Skills

• Cross-functional stakeholder management
• Effective communication and presentation skills
• Negotiation and conflict resolution
• Strategic thinking and decision-making
• Ownership and accountability
• Project Management and Operational Skills
• 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

Basic Qualifications

• Master’s degree and 5 to 8 years of directly related experience

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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen