Gouthami Kannabattula

Scientific Publications & Compliance

• Supervised end-to-end medical content operations across multiple franchises, ensuring compliance and audit readiness.
• Maintained compliance with SOPs and regulatory standards (GPP, ICMJE) across all publications.
• Monitored compliance procedures, developed reports, and identified process gaps.
• Conducted quality control of operational and scientific deliverables.

Project & Change Management

• Led end-to-end project management of publications across global teams.
• Managed integrated project plans, tracked progress, and resolved issues proactively.
• Led change management initiatives during system upgrades, ensuring seamless adoption.
• Efficiently tracked project progress using Smartsheet and ESM platforms.

Subject Matter Expert

• Served as Business SPOC during audits and SME for publication management tools (iEnvision/PromoMats), driving platform adoption and compliance.
• Supported system enhancements, validating business requirements.
• Leveraged AI/GenAI tools to streamline workflows and enhance efficiency.

Analytics, Governance & Stakeholder Engagement

• Performed data analysis and KPI tracking leveraging information from dashboards, delivering performance insights to leadership.
• Facilitated governance forums and cross-functional meetings for strategic alignment.
• Managed stakeholder communication across US, EU, and APAC regions.
• Built global partnerships facilitating seamless collaboration.

Process Improvement & Team Development

• Identified and implemented process improvements, standardizing workflows collaborating with Chief Medical Office Team (US) and enhancing compliance.
• Led and mentored team members, supporting career development.
• Designed onboarding programs covering publication systems and compliance.

• Provided project management support for publication and medical education deliverables across all phases, ensuring compliance with publication policy and GPP guidelines.
• Maintained publication databases (Datavision) with regular quality control checks and audit readiness.
• Delivered training programs on publication tools and organizational best practices, building team capability.
• Collaborated with global and local scientific communications teams to support seamless project execution and in-sourcing initiatives.

• Developed high-quality scientific publications for a hematology product portfolio, including abstracts, poster/oral presentations, slide decks, brochures, and disease area scripts for international congresses (EHA, ASH).
• Collaborated with Scientific Communication Leaders, Subject Matter Experts, and Medical Scientific Liaisons across Europe and USA, demonstrating strong cross-functional and cross-cultural stakeholder management.
• Supported abstract and manuscript submissions for congresses and journals. Conducted literature searches, quality control checks, and proofreading to ensure accuracy and compliance.
• Gained proficiency in publication databases: Datavision, CREDI, MiNova, PubMed, OVID, and EndNote.
• Promoted to Level 2 Scientific Writer within one year of joining and was recruited as full-time employee following successful internship completion.

• Managed electronic data systems and performed root cause analysis to identify factors affecting production yield variations.
• Maintained process authenticity and compliance through precise electronic documentation.
• Conducted quality control checks of batch production records (BPRs) to assure accuracy in upstream and downstream processing of parenteral formulations.