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Requirement of Group Head - Global Labeling (Drug Regulatory Affairs) @ Novartis


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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: Group Head - Global Labeling (Drug Regulatory Affairs)

Job Description:
Job Purpose
The Group Head GL Hyderabad provides leadership including scientific and strategic guidance to the DRA GL Hyderabad team for optimal execution of assigned business deliverables and for development and implementation of the overall strategic vision for the Hyderabad DRA GL group.

Major Activities
1. People Management: Direct people management responsibility for 12-15 associates and the GL Artworks & US Labelling Design sub-group team lead, including performance management and people development
a. Establish and ensure a high performing team for the on-going maintenance of marketed product labelling.
b. Supervise and guide the assigned GL team, oversee and support high quality GL contributions, support label issue management and provide strategic advice.
c. Nurture and mentor DRA GL Hyderabad talent to realize full potential in execution of assigned tasks.
d. Set objectives for group members, ensure adequate training for assigned tasks and evaluate the performance according to Novartis performance-management process.
e. Ensure optimal forecasting, budgeting and monitoring of resource utilisation for assigned activities. Ensure hiring and retention of top talent.
f. Commit to productivity objectives, developing and refining processes, and promoting innovation and external focus. Support and facilitate cross-functional collaboration and ensure optimal support to other GL central sites in Basel and East Hanover as needed.
g. Lead continuous evaluation of productivity (Resource Planning Tool) and customer satisfaction (Customer Satisfaction Survey) in relation to defined processes in order to optimise quality and operations related to the assigned activities.

2. Global Product Information:
a. Drive and optimize the strategy for the development of global labelling for the group’s assigned product portfolio in compliance with the Novartis Pharma Product Information Policy.
b. Train and mentor Novartis associates to ensure adherence to the Novartis Global Labelling process, the Product Information Policy and other labelling relevant internal policies and processes.
c. Ensure up-to-date, regulatory compliant and competitive global labelling documents (Core Data Sheet (CDS), Basic Patient Leaflet (BPL), and Basic Succinct Statement (BSS)), and International Package Leaflet (IPL) for the group’s assigned product portfolio.
d. Ensure high quality and timely documents supporting changes to the CDS and responses to labelling-related Health Authority queries.
e. Ensure high quality and timely regulatory contributions to PSURs.
f. Contribute to overall Global Labelling and liability risk management strategy for Novartis Pharma including review of cross-company pharmacovigilance agreements
g. Oversee the support to DRA Country Pharma Organisations (CPOs) to negotiate globally harmonized local labelling and compliance with GL strategy. Support labelling issue management.
h. Support adequate follow-up on worldwide implementation of CDS in local labelling across the entire label change process.
i. Oversee and support high quality GL contributions the Novartis Portfolio Stewardship process.


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3. Process Improvements: Contribute to and / or lead management and continuous improvement initiatives
4. Member of GL Leadership Team:
a. As a member of the Global Labelling Leadership Team, contribute to the overall strategic direction of the department by active contribution to GL Management meetings and GL Departmental Meetings.
a. Represent DRA GL at internal boards and committees, and during internal audits and external inspections.
b. Review and comment emerging internal and external guidelines and regulations on regulatory, safety, and legal topics.
c. Deputise for Head Global Labelling, as appropriate, e.g. at DRA Management meetings, Portfolio Stewardship Board Meetings, Chairing the Global Labelling Committee.

Key Performance Indicators
1. Lead: Meet the KPIs of the project- timelines, quality, productivity
2. People management- timely completion of performance appraisals, feedback from group
3. Team player- Assessed from global multi-rater feedback (including GLC)

Job Dimensions
Number of associates:
Approx. 25 associates (12-16 direct reports)

Financial responsibility:
(Budget, Cost, Sales, etc.)

Impact on the organization: For assigned products:
To ensure harmonized worldwide labelling through a common Core Data Sheet.
To ensure patient safety through timely and adequate updates of core safety information.
To ensure compliance with internal policies on labelling.
To minimize litigation risks associated to product liability, by overseeing the local implementation of labelling changes worldwide.
To protect worldwide sales and Novartis reputation by ensuring appropriate product labelling worldwide.
To minimise risk of discontinuation of marketed products worldwide due to inappropriate labelling.

Candidate Profile:
Ideal Background

Education: Minimum: MSc in Life Sciences/ M Pharm

Desired: Doctoral Degree or Qualification in Medical Sciences (MBBS/MD/equivalent), or PhD in Life Sciences
MSc/ M Pharm with minimum 8 years experience in DRA, Medical Information or Project Management; proven Leadership

Desired: MBBS/ PhD with at least 6 years of Regulatory/ Medical Writing/ Drug safety work experience.

Experience for handling team for at least 3 years

Languages: Excellent written and oral English

Additional Information:
Experience: 8-9 Years
Education: B.Pharm, M.Pharm, B.Sc, M.Sc-Life Sciences, Ph.D, MBBS
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area:
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID:
End Date: 23rd Oct., 2011

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