Overview
Step into a pivotal leadership role at Novartis as Associate Director, Plain Language Trial Summaries (PLTS), where you will champion transparency and patient engagement in clinical research. You will ensure sustainable compliance with EU Clinical Trial Regulations and Novartis standards, leading the design, preparation, translation, and dissemination of patient-friendly trial summaries. Your expertise will drive process improvements, regulatory alignment, and cross-functional collaboration, making a meaningful impact on patient understanding and public trust in clinical research.
Responsibilities
* Lead and matrix manage delivery of plain language trial summaries, ensuring quality and compliance across therapy areas and development phases.
* Oversee eligibility assessment and disclosure of trial summaries, interpreting and representing trial data accurately in clinical registries.
* Address, resolve, and escalate internal and external queries related to plain language trial summaries.
* Prepare Novartis for new EU CTIS and UK requirements by standardising plain language trial summary templates.
* Develop, test, and implement metrics reporting for trial summary postings, updating work instructions to align with regulatory changes.
* Stay current with global policies and regulations, harmonising Novartis transparency processes and standards.
* Identify barriers to process alignment, create implementation plans, and partner with IT to optimise compliance and harmonisation.
* Represent Novartis to internal and external stakeholders, maintaining effective relationships with global leaders and functional teams.
* Create and maintain SOPs and work practices for trial summaries, managing audits and supporting enhancements to digital tools.
* Lead financial contracts and outsourcing processes for trial summaries, implementing best practices and sharing lessons learned.
Qualifications
* Minimum bachelor's degree, preferably in the sciences.
* Over 10 years' experience in the pharmaceutical industry, including statutory disclosure, trial registration, and results preparation.
* Proven expertise in clinical research development and cross-functional drug development deliverables.
* Experience in writing protocols and clinical summary reports across multiple indications and therapy areas.
* Mastery of clinical trial management systems (CTMS) and document management systems (DMS); ability to use Clinical Trial Application System (CTA).
* Demonstrated leadership in clinical research, project management, medical writing, or related areas.
* Ability to influence and work successfully in cross-divisional, multicultural matrix environments.
* Fluent English (oral and written).
Desirable for the role
* Process and performance orientation, with ability to develop and implement improved processes and report on performance metrics.
* Strong problem-solving, communication, and time management skills, with adaptability to changing environments.
#J-18808-Ljbffr