Senior Manager, Plain Language Trial Summaries
7 days ago
Job Description Summary Join Novartis as Senior Manager, Plain Language Trial Summaries (PLTS) and play a crucial role in advancing clinical transparency and patient engagement. You will independently manage the preparation, translation, and dissemination of patient-friendly trial summaries, ensuring compliance with EU Clinical Trial Regulations and Novartis standards. Your expertise will drive process excellence, regulatory alignment, and cross-functional collaboration, making a meaningful impact on patient understanding and public trust in clinical research. Location: London, UK / Barcelona, Spain / Dublin, Ireland #LI-Hybrid Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Job Description Responsibilities Manage multiple plain language trial summaries through all process steps, maintaining timelines and coordinating documentation for vendor contracts. Arrange and lead PLTS review meetings, oversee document reviews, and ensure study and medical lead input. Oversee finalisation, translation, and distribution of PLTS content by vendors, archiving key documents in management systems. Coordinate communications between vendors and clinical teams to ensure smooth project execution. Interpret and ensure accurate representation of trial data from clinical study reports in plain language summaries. Address and resolve questions from therapy areas and country representatives, identifying and mitigating timeline, quality, or resource issues. Review and maintain the Clinical Disclosure Office PLTS book of work and ensure completion of PLTS request for proposal processes. Stay current with global PLTS work practices and health authority regulations, harmonising Novartis transparency processes and standards. Organise and conduct client trainings to drive quality, compliance, and alignment with changing disclosure requirements. Represent Novartis to internal and external stakeholders, building effective relationships with global and country leaders. Essential for the role: Minimum bachelor’s degree in a scientific discipline preferred. Over 5 years’ pharmaceutical industry experience, with proven cross-functional drug development knowledge. Experience in writing protocols, clinical summary reports, disclosure results, or publications. Experience in multiple clinical indications and/or therapy areas. Prior experience using clinical trial management systems (CTMS) and document management systems (DMS). Proven leadership skills in clinical research, data management, project management, medical writing, or clinical disclosure. Ability to influence and work successfully in complex cross-divisional matrix environments. Fluent English (oral and written). Desirable for the role: Strong negotiation and conflict resolution skills, with a focus on results, compliance, planning, tracking, and problem solving. Proficiency in Good Clinical Practice, knowledge of clinical trial regulations and designs, and adaptability to changing environments. Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Skills Desired Building Construction Clinical Practices Clinical Research Clinical Trials Drug Development Hazard Identification Health Sciences Immunology Intensive Care Unit (ICU) Internal Control Internal Medicine Job Description Medical Information Organization Skills Patient Care Stakeholder Engagement TCP/IP Protocols Utilization Management (UM) #J-18808-Ljbffr
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Dublin, Canada Healthcare Businesswomen’s Association Full timeJob Description Summary Join Novartis as Senior Manager, Plain Language Trial Summaries (PLTS) and play a crucial role in advancing clinical transparency and patient engagement. You will independently manage the preparation, translation, and dissemination of patient-friendly trial summaries, ensuring compliance with EU Clinical Trial Regulations and Novartis...
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Trial Vendor Associate Director
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Speech Language Pathologist
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Global Medical Director – Cell
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Patient Engagement Therapeutic Area Manager
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Dublin, Canada Healthcare Businesswomen’s Association Full timeJob Description Summary The Patient Engagement Therapeutic Area Manager (PETAL) is responsible for a defined scope in the execution of Patient Engagement strategies and plans. Ensures all aspects of the daily operations run effectively and efficiently, identify and resolve upcoming issues, improve processes, ensure quality deliverables. Job Description...
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Patient Engagement Therapeutic Area Manager
1 week ago
Dublin, Canada Healthcare Businesswomen’s Association Full timeJob Description Summary The Patient Engagement Therapeutic Area Manager (PETAL) is responsible for a defined scope in the execution of Patient Engagement strategies and plans. Ensures all aspects of the daily operations run effectively and efficiently, identify and resolve upcoming issues, improve processes, ensure quality deliverables. Job Description...
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Dublin, Canada Mark Anthony Group Inc. Full timeMark Anthony Brands International (MABIUC) is a leading multinational alcohol beverage business and we develop and market a wide variety of alcohol brands ranging from premium spirits to Ready to Drink (RTDs) beverages. Sales of our U.S. focused brands total more than 85m cases per annum through our US affiliate Mark Anthony Brands Inc., the fastest growing...
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Patient Engagement Therapeutic Area Expert
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Dublin, Canada Healthcare Businesswomen’s Association Full timeJob Description Summary The Patient Engagement Therapeutic Area Expert contributes to the implementation of Patient Engagement plans to facilitate Novartis business and provides advice on impact and opportunities and ensures quality deliverables. Job Description Office Location: London (The Westworks), United Kingdom or Dublin, Ireland. #LI-Hybrid Hybrid (12...
