Amgen is a leading biotechnology company committed to discovering, developing, and delivering innovative human therapeutics. With a focus on serious illnesses, Amgen leverages advanced human genetics to transform medicine and improve patient outcomes. The company fosters a collaborative and inclusive work environment, encouraging professional growth and innovation.
Job Description
Key Roles & Responsibilities:
- Perform document-level quality control (QC) (abbreviations, references, data consistency, etc.) to ensure submission readiness.
- Ensure formatting accuracy (layouts, fonts, styles, spacing) per Amgen’s submission guidelines.
- Coordinate document collection with cross-functional teams and ensure publishing readiness.
- Support cross-functional document review processes and participate in project management (timeline tracking, scheduling meetings).
- Use required authoring tools and technology platforms for regulatory writing.
- Attend cross-functional meetings to gather and share relevant document-related information.
- Work on documents such as:
- Clinical Study Reports (CSRs)
- Investigator’s Brochures (IBs)
- Plain Language Summaries (PLS)
- Risk Management Plans (RMPs)
- Original Protocols & Amendments
- Informed Consent Forms (ICFs)
- Ensure compliance with SOPs, templates, and Regulatory Writing Style Guides.
- Maintain product-specific reference libraries across therapeutic areas.
Basic Qualifications:
- Bachelor’s degree in Science (or related field) from an accredited university.
Preferred Qualifications:
- Prior experience in formatting, QC reviews, and managing regulatory/clinical documents in pharma/biotech.
- Basic scientific/medical knowledge and exposure to statistical principles.
- Strong written & verbal communication skills.
- Ability to collaborate with cross-functional teams and work independently.
- Excellent attention to detail, organizational skills, and project management abilities.
- Proficiency in Microsoft Office, SharePoint, and document management systems.
