Choose LocationChoose Location# Senior Manager, Plain Language Trial SummariesREQ-********Dec 23, ****Spain### SummaryJoin 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.
### About the Role**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.
**Why Novartis:****Benefits and Rewards:** Read our handbook to learn about all the ways we'll help you thrive personally and professionally:DevelopmentDevelopmentSpainBarcelona Gran VíaES06 (FCRS = ES006) Novartis Farmacéutica, S.A.Dublin (NOCC), IrelandLondon (The Westworks), United KingdomResearch & DevelopmentFull timeRegularNoNovartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.REQ-********### Senior Manager, Plain Language Trial SummariesREQ-********### Senior Manager, Plain Language Trial Summaries
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