Business Director – UK&I, BENELUX
Medtronic
Associate Director, Plain Language Trial Summaries
Novartis
full-time
Posted on:
Location Type: Hybrid
Location: London • 🇬🇧 United Kingdom
Visit company websiteJob Level
Senior
About the role
- 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.
Requirements
- 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).
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 research developmenttrial registrationresults preparationwriting protocolsclinical summary reportsmetrics reportingSOP creationaudit managementfinancial contracts managementoutsourcing processes
Soft skills
leadershipproject managementinfluencingrelationship managementcross-functional collaborationproblem-solvingcommunicationadaptabilitystakeholder engagementteamwork
