500+ Ongoing clinical trials;160+ Projects in clinical development;80+ Major submissions planned 2020-
2022. Novartis GDD (Global Drug Development) oversees the development of new medicines
discovered by our researchers and partners. It drives breakthrough innovations to improve and extend
the lives of millions.
Your key responsibilities:
Your responsibilities include, but are not limited to:
• Provide cross-divisional Clinical submission contributions and serve as content/technical contributor for Clinical submission document requirements. Contribute to the global cross-functional Clinical Submission Team to ensure all Clinical submission documents are delivered in accordance with timelines, high quality, operational and technical procedures; report Clinical submission progress and issues with a resolution plan to Group Heads of Submission Management, Regulatory Affairs and other relevant line units Heads, as needed.
• Contribute to the Clinical Submission Planning Meeting with cross functional team members to define Clinical submission content, data pooling strategies for summary documents (e.g.Summary of Clinical Efficacy (SCE) and Summary of Clinical Safety (SCS)) and identify full Clinical Submission Team composition.
• Facilitate definition of delivery schedule and batch content for statistical outputs and medical writing strategy ensuring continuous receipt, review and integration into Summary Documents (e.g. SCE, SCS and Clinical Overview (CO)). Contribute to the identification of all Clinical submission deliverables (including all relevant trials); negotiating and tracking timelines, accountabilities and responsible individuals assigned,in collaboration with Clinical Submission Team members for HA filings; include on RA submission tracker and maintain with real-time updates.
• Identify issues and potential resource gaps effecting preparation and delivery of Clinical submission documents.Co- facilitate extended Clinical Submission Team meetings to synchronize submission messages with Senior Management at:
a. Clinical Submission Team Kick-off - goal is to ensure clear submission strategy and early target labeling messages endorsed by Senior Management and understood by all Preclinical and/or Clinical submission team members; all contributing line units present proactive assessment of key issues and actions within their lines which will effect timely delivery of Preclinical and/or Clinical submission documents. Agenda and meeting minutes issued by Submission Manager (SM).
b. Key Message Harmonization Meeting - goal is to ensure Senior Management and cross functional development departments are aligned on key efficacy, safety, Biopharmaceutics and Clinical Pharmacology messages following receipt of key pooled Clinical data. Agenda and meeting minutes issued by SM. Meeting cofacilitated with RA.
• Lead or contribute to regularly scheduled Clinical Submission Team meetings, provide agenda, minutes and updates to deliverable timelines; ensure timelines are in accordance with Novartis processes. Represent Clinical Submission sub-team at RA Core Submission Team Meetings and RA submission team operations' meetings. In collaboration with the Clinical authors co-facilitate SCE and SCS Data Analysis Review Meetings to align analysis interpretation of these Clinical summary documents for inclusion into the SCE and SCS draft reports as applicable
• Co-facilitate Summary Document Report Review Meetings to aid in the development of these documents from draft to content final in collaboration with Medical Writers and Clinical Authors via direct team interaction and dialog; facilitate obtaining final approval from Clinical, Analytics, Safety and RA Therapeutic Area Heads.
• Contribute to the authorship of the following (but not limited to), supportive Clinical submission documents; ensuring content and technical compliance with International Conference on Harmonization (ICH) and local Health Authority guidelines:
a. CTD 1.3.4. Financial Disclosure Certification
b. CTD 1.4.3. Information about the experts - clinical
c. CTD 1.9. Information relating to clinical trials
d. CTD 2.7.5. List of references
e. CTD 2.7.6. Synopsis of Individual Studies
f. CTD 5.2 Tabular Listing of All Clinical Studies
g. CTD 5.3.7. Statement on CRFs and individual listings
• Co-facilitate discussion and proactive preparation with relevant Clinical submission team members for summary Clinical site information supporting FDA Office of Scientific Investigations (OSI) Inspections for each FDA submission or information supporting EMA accelerated assessment. Contribute to the validation checks of RA cross reference links established for all managed Clinical Submission deliverables within the Common Technical Document (CTD) prior to Health Authority dispatch.
What you'll bring to the role:
• Bachelor's degree, equivalent education/degree in life science/healthcare or equivalent experience is required.
• Fluent English (oral and written)
•≥ 2 years' experience in Clinical research with proven proficiency in global Clinical development
• Fundamental leadership of cross-functional teams. Has demonstrated teamwork, communication and organizational skills. Works effectively and is able to establish relationships with other line functions
• Strong working knowledge in world wide regulatory requirements for drug registration (e.g., Common Technical Document)
• Previous experience in medical writing, Preclinical and/or Clinical submissions, and interactions with health authorities is preferred
• Solid computer technical skills (Word / Excel / Power-point/MS Project) and ability to learn new systems quickly
Why consider Novartis?
799 million. That's how many lives our products touched in 2019. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
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Global Drug Development
Company / Legal Entity
CNIBR Co. Ltd.
Research & Development