A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Senior Principle TOPI Lead
Job Description
The Senior Principal Training Operations and Process Improvement Lead, leads quality deliverables across platforms, franchises or therapeutic areas. Drives participation and inputs within Data Operations (DO), and cross funcationally where applicable, in the delivery of quality data and programs, processes and documentation which satisfies regulations and aligns with industry best practices for Data Management and Statistical Programming (Data Operations). Develops simple and reproducible strategies to ensure quality deliverables, and enables organization to be agile and deliver timely to drug development programs.
1. Achieve overall goals as set each year by Global Head Data Operations, GDO.
2. Achieve high level of quality, timeliness and customer satisfaction across Quality and Compliance activities, deliverables and support.
3. No critical findings as result of internal inspection, routine audits or health authority inspections relating to activities/deliverables supported by DO.
4. Effectiveness of participation in internal and external networks/initiatives.
Candidate Profile
Bachelor’s degree recommended in Life Sciences, Computer Science, Medical Informatics or equivalent. Preferred Post-graduate university or college degree recommended in Life Sciences, Computer Scien Fluent English (oral and written).
1. Significant relevant experience and knowledge in the Pharmaceutical or Device Industry.
2. Expert in regards to regulatory requirements relevant to Data Management and Statistical Programming (e.g. GCP, ICH).
3. At least 9 years of experience in global drug development, within the pharmaceutical or device industry
4. A demonstrated expert in Data, Programming and Process Quality, providing guidance, mentoring and support to DO Organization.
5. Superior interpersonal and communication skills. Builds positive departmental and inter-departmental relationships.
6. Outstanding verbal and written skills.
7. Proven ability to proactively identify issues, recommend and implement solutions
Additional Information:
Experience: 1 to 5 years
Qualification : Bachelor’s degree in Life Sciences
Location : Hyderabad
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Research & Development
Job ID: 237397BR
Last Date: 21st April, 2018
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