Organisational Effectiveness Manager
Sheraton Heathrow Hotel
Senior Manager, Plain Language Trial Summaries
Novartis
full-time
Posted on:
Location Type: Hybrid
Location: London • 🇬🇧 United Kingdom
Visit company websiteJob Level
Senior
About the role
- 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.
Requirements
- 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).
Benefits
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial managementmedical writingdata managementproject managementprotocol writingclinical summary reportsdisclosure resultspublicationsplain language summariestranslation
Soft skills
leadershipcommunicationrelationship buildinginfluencingproblem solvingcoordinationorganizationteam collaborationtrainingadaptability
Certifications
bachelor’s degree in scientific discipline
