Associate Director, Plain Language Trial Summaries

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.

Essential for the role:

• 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.

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.