Career Category RegulatoryRoles 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, Investigators 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 QualificationsGraduated with a Bachelors degree in science from an accredited college or universityPreferred Qualifications
Prior 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 crossxe2x80x90functional 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)