Senior Manager, Plain Language Trial Summaries
Senior Manager, Plain Language Trial Summaries
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Job Description
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 bachelors 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)Required Experience:
Senior Manager
Employment Type
Full-Time
