Global Head, Regulatory Writing- Innovative Medicines job in East Hanover
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
In this role you will lead a large global team of expert regulatory medical writers engaged in the timely development of critical high quality regulatory documents for submission to health authorities in support of global marketing authorization applications and post-registration activities for Innovative Medicines (Pharma and Oncology), compliant with internal and external guidelines and business objectives.|
1. Global Line Function Head for Regulatory Writing in Innovative Medicines (Pharma and Oncology).
2. Manage quality, timeliness, efficiency and high scientific standards for written and electronically published regulatory documents produced by the group and for global teams, across geographical boundaries.
3. Oversight of all functional and operational activities for the development of documents for early and full development programs and commercial products within GDD. Ensure synergies between programs and divisions at a global level.
4. Ensure adherence to internal and external guidelines and to regulatory requirements.
5. Work cross-functionally in close collaboration with other GDD and GDO line functions to develop guidance documents and train GDD associates on document authoring and submission requirements.
6. Development of document strategy and key messaging for submissions and implementation of resultant actions.
7. Member of relevant boards (e.g. RWS LT)
8. Responsible for Innovative Medicines RW resource planning and management.
9. Lead continuous improvement initiatives in RWS and actively participates in or leads cross-divisional initiatives.
10. Interact with GPHs/GCPHs to ensure proper prioritization of programs and implement adequate resources according to agreed strategy and timelines.
11. Recruit talent, manage performance and develop associates.
12. Commitment to develop people, processes, innovation, and external focus.
13. May act as deputy for Global Head, RWS.Advanced degree or equivalent experience in clinical development and regulatory submissions is required.
Fluent English (oral and written).
• ≥ 10 years' experience in clinical research with proven proficiency in global development.
• Successful experience on multiple NDAs/MAAs and/or sNDAs/Type II Variations.
• Experience across Pharma and Oncology preferred though not required.
• Excellent knowledge of worldwide regulatory requirements for drug registration.
• Strong organizational leadership skills in leading change, innovation, talent development, and business management.
• Recognized leadership, cultural awareness and advanced negotiation skills
• Team management experience with cross-functional and global responsibilities.
• Demonstrated innovation experience