Seniorr Associate Regulatory Writing

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.

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.

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