Description
**Roles and Responsibilities**
+ **Performs document-level QC (including abbreviations, references to sources, data in text versus data in tables, figures, or graphs, etc.) to ensure submission readiness quality**
+ Ensures the **consistency** and **accuracy** of layouts, fonts, margins, styles, and spacing, logical content organization, and proper use of headings, tables, images, and footnotes applying Amgen submission readiness formatting guidelines to create professional documents
+ Coordinates document collection with cross-functional team members and ensures publishing readiness of the documents
+ Participates in collaborative team activities for noncomplex documents, including support to collect input from authors/reviewers
+ Participates in the cross-functional document review process
+ Participates in project management activities, i.e., timeline tracking and scheduling meetings with team members
+ Learns and uses organizationally required authoring tools and technology platforms
+ Attends cross-functional meetings with writers and departments, as appropriate, to share and gather information relevant for successful completion of assigned documents
+ **Documents in scope include,** but are not limited to: Clinical Study Reports, Observational Research Study Reports, Plain Language Summaries, Investigator’s Brochures, local Risk Management Plans, noncomplex Original Protocols/ Protocol Amendments, Plain Language Protocol Summaries, and Informed Consent Forms
+ Understands and complies with SOPs, templates, best practices, policies, Regulatory Writing Style Guides
+ Compiles and maintains product-specific reference libraries across therapeutic areas
**Basic Qualifications**
**Graduated with a Bachelor’s degree in science from an accredited college or university**
**Preferred Qualifications**
+ **1-2 years of experience formatting, performing QC reviews, and managing the coordination of regulatory/clinical documents at a pharma/biotech or similar organization**
+ Some scientific or medical knowledge
+ Some exposure to basic statistical and medical communication principles
+ Strong oral and written communication skills
+ Able to collaborate with others and build solid and positive relationships with cross‐functional team members
+ Able to work independently and problem solve
+ Attention to detail and accuracy
+ Organizational skills in time and project management, including ability to manage multiple projects simultaneously
+ Strong knowledge of document management systems and typical office applications (eg, Microsoft Office, SharePoint)
