Associate, Regulatory Writing

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)