Amgen is hiring for two Regulatory Writing positions in Hyderabad, India: Senior Associate Regulatory Writing and Senior Associate Regulatory Writing. Both positions are full-time, onsite roles within Amgen’s Regulatory career category.

These opportunities involve preparing and managing regulatory documents such as Clinical Study Reports (CSRs), Investigator Brochures (IBs), protocols, protocol amendments, Plain Language Summaries, Plain Language Protocol Synopses, and Informed Consent Forms (ICFs).

The roles are suited to professionals interested in regulatory medical writing, clinical documentation, regulatory submissions, cross-functional collaboration, and pharmaceutical research and development.

Amgen Regulatory Writing Jobs – Overview

1. Senior Associate Regulatory Writing – R-255150

The first Amgen Regulatory Writing job focuses on independently authoring routine to moderately complex regulatory documents and managing them through review, QC and approval.

Key Responsibilities

The selected candidate will:

• Independently author routine to moderately complex regulatory documents.
• Prepare ICFs and ICF amendments.
• Develop Plain Language Protocol Synopses (PLPS) and amendments.
• Author sections of Clinical Study Reports, including synoptic, abbreviated and standard CSRs.
• Support pivotal CSRs.
• Prepare protocol amendments and country-specific protocol supplements.
• Support minor or focused Investigator Brochure updates.
• Manage document versions and reviewer comments.
• Coordinate approval workflows for assigned documents.
• Ensure scientific accuracy and consistency across regulatory documents.
• Ensure documents align with source data and program objectives.
• Prepare documents for QC and inspection readiness.
• Follow applicable guidance documents and SOPs.
• Support audits and inspections when required.
• Collaborate with Clinical, Safety, Regulatory and Study teams.
• Participate in document-related meetings.
• Escalate risks, scope changes and timeline concerns.
• Track assigned deliverables and timelines.
• Participate in training, knowledge-transfer and process-improvement activities.

Key Skills

• Regulatory writing
• Clinical documentation
• Scientific writing
• Cross-functional stakeholder management
• Document management
• Review coordination
• Project management
• Risk identification
• Regulatory compliance
• Communication and presentation

2. Senior Associate Regulatory Writing – R-255889

The second Senior Associate Regulatory Writing position at Amgen focuses on writing and editing non-complex regulatory documents and supporting cross-functional document development.

Key Responsibilities

The selected candidate will:

• Write and edit non-complex regulatory documents.
• Prepare simple Clinical Study Reports.
• Support Investigator Brochures.
• Prepare protocols and protocol amendments.
• Develop Plain Language Protocol Synopses.
• Prepare Plain Language Summaries.
• Develop Informed Consent Forms and amendments.
• Support collaborative activities for regulatory documents.
• Collect inputs from authors and reviewers.
• Participate in cross-functional document reviews.
• Support comment triage and review meetings.
• Incorporate reviewer feedback into subsequent drafts.
• Generate appropriate in-text tables and figures.
• Manage regulatory document development according to guidelines and timelines.
• Work with project teams to track document progress.
• Coordinate reviews and support document finalization.
• Learn and use required authoring tools and technology platforms.
• Participate in cross-functional meetings.
• Follow SOPs, templates, regulatory writing style guides and best practices.

Documents Covered

The role may involve regulatory documents including:

• Clinical Study Reports
• Observational Research Study Reports
• Plain Language Summaries
• Investigator Brochures
• Local Risk Management Plans
• Original Protocols
• Protocol Amendments
• Informed Consent Forms

Qualifications and Background

The provided Amgen job descriptions do not specify a particular degree, academic discipline or minimum number of years of experience. Therefore, candidates should review the official posting carefully before applying rather than assuming a specific degree requirement.

The positions are particularly relevant to professionals with experience or interest in:

• Regulatory Writing
• Medical Writing
• Clinical Research
• Regulatory Affairs
• Pharmaceutical R&D
• Clinical Documentation
• Scientific Writing
• Regulatory Documentation
• Drug Development

For the R-255150 position, the description emphasizes independent authorship of routine to moderately complex regulatory documents.

For R-255889, the description emphasizes writing and editing non-complex documents, collaborative document development and cross-functional review.

Regulatory Writing Skills at Amgen

Candidates interested in these Amgen Hyderabad jobs should be familiar with areas such as:

Regulatory Writing • Clinical Study Reports • Investigator Brochures • Protocols • ICFs • Plain Language Summaries • SOPs • Regulatory Guidelines • Document Management • Cross-functional Collaboration • Quality Review

Strong communication, organization, ownership and the ability to manage multiple deliverables are particularly relevant to the responsibilities described in the postings.

Benefits and Work Environment

The supplied job descriptions do not provide a detailed compensation or benefits breakdown for these specific positions.

Both openings are listed as:

• Full-time
• Onsite
• Hyderabad, India
• Regulatory career category

Amgen also states in the supplied posting that it provides equal employment opportunities and reasonable accommodation for individuals with disabilities.

How to Apply

Application Link For Seniorr Associate Regulatory Writing

Application Link For Senior Associate Regulatory Writing