Job Description

Key responsibilities 重要职责

1. Study Start-up & Submission Execution: Lead, coordinate and manage execution of start-up activities and regulatory submissions for assigned trials
2. Productivity Oversight: Provide local regulatory insights and support continuous improvement and innovation initiatives related to SSU
3. Stakeholder Engagement & Communication: Liaise with cross functional teams to ensure alignment and timely delivery of start-up and submission activities
4. Quality Oversight: Ensure high quality submissions and proactively manage study start-up compliance risks or process gaps

Main job tasks 主要工作任务

1. Study Start-up & Submission Execution

• Co-develop regulatory strategy and SSU plans for assigned trials with TA Head, head of SSU and Phase 1 trial and relevant CDC-TMs, in alignment with CDC strategy and industry best practice.
• Coordinate the execution of start-up activities for assigned trials.
• Support customization, translation and/or preparation key documents, such as Informed Consent Forms (ICFs), patient materials, Labels, and Clinical Trial Application (CTA) documents at country and site levels, including updates requested by EC and/or HA.
• Provide support on the preparation, review and submission of Health Authority (HA) and/or Ethics Committee (EC) dossiers, ensuring compliance with ICH GCP regulations, local requirements, and Novo Nordisk processes.
• Track and ensure regulatory milestones and timelines are met at country and site levels.
• Communicate with site directly when needed, to ensure proper progress of trial startup activities at site.
• Execute site activation activities, including ‘Green Light’ readiness, coordination of supplies and equipment delivery, collection of essential documents, and preparation of drug release documentation, if needed.
• Ensure the assignment and execution of internal and external (site staff) trainings as per training plan.
• Identify and share potential risks on the trial and site level and proactively take action to prevent or mitigate.
• Plan and track regulatory milestones in CTMS at country and site levels.

2. Productivity Oversight

• Provide local regulatory insights and intelligence to trial teams and Global/Regional/CDC stakeholders.
• Support continuous improvement and innovation initiatives related to SSU, compliance and regulatory submissions processes

3. Stakeholder Engagement & Communication

• Liaise with cross-functional teams to ensure alignment and timely delivery of start-up and submission activities.
• Participate in kick-off meetings with trial start-up team, provide input to submission, site identification and selection and local start-up timelines, and monitor and communicate critical issues that may impair trial progress.
• Build and maintain excellent relationships with clinical sites, GCP office and Ethics Committees, etc.

4. Quality Oversight

• Ensure start-up and submission activities adhere to ICH GCP, regulatory requirements and internal SOPs.
• Contribute to Inspection Readiness and support audits and/or inspections.
• Proactively identify and escalate study start-up compliance risks or process gaps.

Other areas of responsibility 其他领域职责

• Attend and represent as Novo Nordisk in industry associations for discussion of relevant topics such as accelerate trial startup, etc to improve the China R&D and clinical trial ecosystem.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, or a related field is required. Advanced degree preferred.
• Excellent English on both written & verbal.
• At least 5 years of experience in clinical trials, regulatory affairs, or submission management.
• Extensive experience in regulatory submissions and a thorough understanding of regulatory guidelines, dossier requirements, and global clinical trial application processes.
• Proficiency in digital tools, clinical trial and submission management systems and publishing software
• Strong project management capabilities, including tracking, planning and prioritization​
• Ability to creatively solve complex problems and drive the development of practical solutions.
• Excellent written and verbal communication, presentation skills, and expertise in managing relationships with internal and external stakeholders at all organizational levels.
• Strong critical thinking and analytical skills to evaluate risks, identify opportunities, and work with high attention to detail.
• Ability to champion the implementation of agile ways of working and adoption of new digital tools.
• Demonstrated ability to ensure high-quality execution of clinical trial activities in compliance with ICH-GCP, regulatory requirements, and internal SOPs.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.