About the Role
As a Senior Manager of Plain Language Trial Summaries (PLTS) your primary accountability will be to independently provide project management and execution to ensure quality PLTS postings are prepared, translated and disseminated to investigational sites in compliance with the EU Clinical Trial Regulations and the Novartis Position on Clinical Study Transparency across BioMedical Research, Global Drug Development, Global Medical Affairs and local affiliates.
Fully home based and part of a committed and focused team working across multiple Phases and therapy areas. Applications from those with a Study Lead (Clinical Trials), Clinical Study Report (CSR) development, Clinical Site Management, Patient Safety, Medical Writing or similar background would be welcome.
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Key Responsibilities
• Manage multiple PLTS through the entire process ensuring timelines are maintained. PLTS process steps include gathering required documentation for vendor contract preparation, arranging and/or leading PLTS review meetings, reviewing PLTS documents, ensuring study lead and medical lead review of PLTS, coordinating PLTS content finalization, PLTS translation and distribution by vendors and archiving of key documents in the document management system. Responsible for coordination of communications between vendor and the clinical team.
• Interpret, discuss and ensure appropriate trial data from the CSR is accurately represented in the PLTS. Independently address and resolve questions received from the therapy areas and country representatives. Identify potential timeline, quality, or resource issues.
• Review and maintain the CDO PLTS book of work in the Clinical Disclosure Office (CDO) Analysis and Reporting Tool and ensure the PLTS request for proposal process is complete for submission to the vendors.
• Responsible for staying current with the global PLTS work practice & health authority regulations to ensure harmonization of Novartis transparency processes and standards. Identify barriers to alignment of processes and discuss within the PLTS CDO team an implementation plan.
• Independently coordinate and conduct routine client trainings within BioMedical Research, Global Drug Development, Global Medical Affairs and local affiliates to drive quality and compliance and organizational alignment to changing disclosure requirements.
• Independently represent Novartis to internal and external stakeholders. Develop and maintain effective working relationships with global and country multidisciplinary leaders, such as Study Leads, M.D.s, medical writers, statistical programmers, and vendor project management teams.
• Review updates to the PLTS work practice and other CDO SOPs and preparation for external inspections & internal audits.
• Participate in the assessment, preparation and review of monthly PLTS disclosure metrics.
• Apply a continuous improvement mind set ensuring best practices are shared continually driving to deliver the most productive processes.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
• Several years pharmaceutical industry experience with proven knowledge in cross functional aspects of drug development
• Proficiency in Good Clinical Practice, knowledge of clinical trial regulations and clinical trial designs.
• Experience in writing protocols/clinical summary reports/disclosure results or writing publications, exhibit copy etc.
• Experience in multiple clinical indications and/or therapy areas and prior experience using clinical trial management systems (CTMS) and document management systems (DMS).
• Proven leadership skills in a position within Clinical Research Development, Data Management, Project Management, Medical Writing, Clinical Disclosure or related areas.
• Ability to influence and successfully work within a complex cross divisional matrix. Previous experience leading or working within a multidisciplinary team in a matrix environment
• Strong negotiation & conflict resolution skills
• Ability to adapt to changing environment.
Why Novartis:
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
https://www.novartis.com/about/strategy/people-and-culture
You'll receive
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Division
Development
Business Unit
CLINICAL DEVELOPMENT & CMO GDD
Location
United Kingdom
Site
London
Company / Legal Entity
Novartis Pharmaceuticals UK Lt
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No