Senior Manager, Plain Language Trial Summaries

Join Novartis 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

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.