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 : Team Lead, Global Labeling
Job Description
Leadership/Managerial
• Manage direct reports assigned to the GL team: DRA Global Labelling As-sociates, Specialists, and Managers
• Manage performance (set objectives, review performance and plan com-pensation).
• Develops associates (development/training plans, Organizational Talent Review, coaching and mentoring associates).
• Responsible for establishing a training program, provide training, establish and oversee mentoring of all new hires.
• Creates a stimulating and fulfilling work environment with a strong focus on co-operation, creativity and productivity as related to their assigned tasks and in associates meeting their objectives
• Establish and ensure a high performing team assigned for the on-going maintenance of marketed product labelling.
• Supervise and guide the assigned GL team: provide day-to-day oversight for direct reports in support of high quality GL contributions, support label issue management and provide strategic advice.
• Set labeling strategy, in collaboration with the GL-TAL, for assigned GL team on: developmental activities including the Developmental CDS; pro-vide labelling guidance on key market labelling for support of assigned products.
• Oversee the PSUR process and ensure DRA regulatory input for products handled by direct reports.
• Oversee the IPL process for products handled by direct reports – ensure preparation, updating and amending of the International Package Leaflets (IPL) for all Pharma products in compliance with the Core Data Sheet changes.
• Ensure optimal resource utilisation for assigned activities. Ensure hiring and retention of top talent.
• Ensure timely communication on projects and issues to the GL-TALs and Franchise, key stakeholders and DRA Global Labelling Leadership team.
• Serve as a role model and embrace Novartis Values and Behaviours.
• In close collaboration with the Global Labeling Therapy Area Leader aligns the teams accordingly including developing and implementing plans that maintain group productivity and compliance including transition plans when functional changes affect the group.
• Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes. Represent GL during internal and external inspections.
• Represent GL on local Quality Assurance (QA) teams and workstreams (e.g. Audit and Inspection Readiness)
• Oversees the implementation of strategies to improve the quality and effi-ciency in labeling activities. Global Product Informat
Candidate Profile
MSc in Life Sciences/ M Pharm Desired: Doctoral Degree or Qualification in Medical Scienc-es (MBBS/MD/equivalent), or PhD in Life Sciences Excellent written and oral English MSc/ M Pharm with minimum 8 years of experience in DRA, Medical Information or Project Management; proven Leadership Desired: MBBS/ PhD with at least 4 years of Regulatory/ Medical Writing/ Drug safety work experience High level of organizational awareness, advanced interpersonal skills, and strong quality and customer focus.
Additional Information:
Experience: 4 - 8 years
Qualification : M.Sc, M.Pharm
Location : Hyderabad
Industry Type: Pharma
Functional Area: Quality
Job ID: 244331BR
Last Date: 21st July, 2018
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