Associate, Regulatory Writing

3 weeks ago

Hyderabad, Telangana, India Amgen Inc Full time
Job 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 theconsistencyandaccuracyof 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 Qualifications

- Graduated with a Bachelors degree in science from an accredited college or university

Preferred 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 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)

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