Senior Associate Regulatory Writing

Amgen SA; Hyderabad; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Amgen SA is seeking a Regulatory Writer to draft and edit non-complex regulatory documents, such as clinical study reports, investigator brochures, and protocols, ensuring alignment with timelines and regulatory standards. The role involves collaboration with authors, reviewers, and cross-functional teams to gather input and finalize documentation.

The position emphasizes learning corporate authoring tools and participating in cross-functional reviews, with responsibilities spanning table/figure

Responsibilities

• Writes and edits non-complex regulatory documents (eg, simple clinical study report, investigator brochure, protocol, protocol amendments, Plain Language Protocol Synopsis, Plain Language Summary)
• Participates in collaborative team activities for non-complex documents, including support to collect input from authors/reviewers
• Participates in cross-functional document review, comment triage, meetings, and incorporation of feedback for later drafts or finalization
• Generates appropriate in-text tables and figures
• Manages development of regulatory documents to meet guidelines and timelines; collaborates with Project Teams to track progress and ensure regulatory standards for submission
• Learns and uses organizational authoring tools and technology platforms
• Attends cross-functional meetings with writers and departments to gather information for successful completion of projects
• Documents in scope include: Clinical Study Reports, Observational Research Study Reports, Plain Language Summaries, Investigator Brochures, local Risk Management Plans, non-complex Original Protocols/ Protocol Amendments, and ICFs
• Understands and complies with SOPs, templates, best practices, policies, Regulatory Writing Style Guides

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

• Writes and edits non-complex regulatory documents (eg, simple clinical study report, investigator brochure, protocol, protocol amendments, Plain Language Protocol Synopsis, Plain Language Summary) and simple standalone documents (eg, informed consent forms and amendments)

• Participates in collaborative team activities for non-complex documents, including support to collect input from authors/reviewers

• Participates in the cross-functional document review process, comment triage, meeting attendance, and incorporation of feedback for development of subsequent drafts or for finalization

• Generates appropriate in-text tables and figures

• Manages the development of regulatory documents, ensuring compliance with guidelines and timelines; collaborate with Project Teams to track progress, facilitate reviews, and ensure documents meet regulatory standards for submission.

• Learns and uses organizationally required authoring tools and technology platforms

• Attends cross-functional meetings with other writers and departments, as appropriate, to share and gather information relevant for successful completion of their own and inter-dependent projects

• Documents in scope include, but are not limited to: Clinical Study Reports, Observational Research Study Reports, Plain Language Summaries, Investigator Brochures, local Risk Management Plans, non-complex Original Protocols/ Protocol Amendments, and ICFs.

• Understands and complies with SOPs, templates, best practices, policies, Regulatory Writing Style Guides

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.