Medical Writer Job Vacancy-Novartis HyderabadFebruary 5th, 2010 Posted by VFreshers
About Company :
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 us one of the most rewarding employers in our field.
Job Position : Operations, Audit Readiness and Process Excellence Specialist
Experience : 1 – 3 Years
Work Place : Hyderabad / Secunderabad
Job Responsibilities :
- Design, develop and implement process improvement projects for Franchises, using LEAN strategies.
- Develop and implement comprehensive Management Information System including metrics capture, analysis and reporting that supports senior management’s need for effective information and control. Liaison with other departments as necessary to implement any MIS project.
- Develop methods to establish training plans for Franchises (including use of Training Needs Analysis) and ensure training (including materials, methods, availability and assessment) are aligned with Franchise training globally.
- Ensure training records are correctly logged, maintained and stored
- Develop and maintain relationship with Pharma Development Training and other Novartis training colleagues
- Assist in the revision of cross functional documentation and training materials when a process is updated or developed.
- Performs regular audits of Franchise processes and documentation across functional areas per schedule.
- Provides interpretation of GCP regulations, guidelines, policies and procedures, and provides sound guidance to Novartis personnel, both verbal and written.
- Provides regulatory /compliance guidance and interpretation and represents Franchise compliance and quality in internal and external meetings.
- Graduate/Post-Graduate in any discipline. Six-Sigma training/projects desirable
- Strong understanding of process control and improvement methodology
- Hands-on experience of a clinical development process, preferably in the realm of Data Management, Biostatistics, Medical Writing, Clinical Quality and Training
- Knowledge in computer technology and ability to support IT systems
- Good understanding of GCP and CFR part 11 requirements, and audit requirements
- Skilled in MS Excel and /or statistical software
Website : http://www.novartis.com