Support study concept development, including data and evidence source landscaping, study synopsis drafting support, protocol drafting support, review coordination, scenario planning, comment collation, version tracking, and final review package preparation.
Provide structured drafting, documentation, and coordination support to enable Global Evidence Generation to define evidence questions, study concepts, scientific design, methodology strategy, source selection, and final sign-offs.
How You Will Contribute
Evidence Source Landscaping
•Conduct source landscaping across real-world data, registries, claims, electronic health records, clinical trials, literature, primary data collection, and other available evidence sources.
•Summarize source coverage, strengths, limitations, access constraints, quality considerations, and selection tradeoffs.
•Prepare source-landscape outputs and store source summaries and decision rationale in the appropriate repository.
•Synopsis and Protocol Support
•Draft synopsis shells, first-pass synopsis content, simpler or standardized protocol sections, and supporting materials using approved templates and approved AI support where applicable.
•Review and manually refine AI-supported or first-pass content for clarity, completeness, formatting, and alignment with study intent.
•Update synopsis and protocol versions, track changes, collate comments, and prepare final review packages.
•Route final approved materials and maintain review history, comments, decisions, and supporting evidence.
•Cross-Functional Review Coordination
•Gather input from required stakeholders through appropriate forums or systems in accordance with standard operating procedures.
•Collate open questions, conflicting inputs, decision points, and action items for Global Evidence Generation review.
•Escalate scientific, strategic, design, methodology, source-selection, or operational issues to Global Evidence Generation owners.
•Support standardization of study templates, source-landscaping outputs, review trackers, and handoff materials.
•Digital, Automation, and AI-Enabled Ways of Working
•Use approved AI-supported drafting tools to develop first-pass study content and supporting materials where appropriate.
•Apply human review to AI-supported outputs to confirm clarity, completeness, scientific alignment, traceability, privacy, quality, and compliance.
•Use approved digital tools, evidence repositories, and study systems to maintain source summaries, version history, review comments, decisions, and final materials.
•Identify repeatable study-design support activities that may benefit from standardization or responsible automation.
Skills and Qualifications
•·More than 3 years of related work experience and more than 2 years of experience in the biopharmaceutical industry.
•Experience in evidence generation, clinical or study operations, real-world evidence or HEOR operations, study design support, protocol coordination, medical writing operations, or scientific project coordination is preferred.
•Experience coordinating cross-functional review, maintaining version-controlled study materials, and preparing review packages is preferred.
•Technical and Functional Skills
•Working knowledge of evidence generation study design, protocol and synopsis workflows, data-source landscaping, and cross-functional review coordination.
•Ability to summarize evidence-source options, limitations, access constraints, quality considerations, and selection tradeoffs.
•Familiarity with study synopsis and protocol templates, version control, comment collation, and review-package preparation.
•Strong scientific writing, documentation, organization, and cross-functional coordination skills.
•Familiarity with approved AI-supported drafting tools, evidence repositories, real-world data sources, and study systems is preferred.
•Ability to recognize and escalate scientific, strategic, design, methodology, source-selection, and operational issues to appropriate accountable owners.
•Ability to manage multiple concurrent study-development workstreams while maintaining accurate, complete, and traceable documentation.
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Education
•A degree in a scientific, medical, life sciences, pharmacy, public health, epidemiology, medical writing, health economics, or related discipline is required.
