Job Purpose : Lead a high-performing Center of Excellence (COE) responsible for transforming the infrastructure that supports the compliance and commercial requirements of the US Pharmaceuticals Material Approval Process (MAP) through the optimization of system capabilities, end-
user interactions, and continuous improvement methodology. Major Accountabilities :
Responsible for setting strategy, in partnership with the Head of MAP, through a functional transformation
Act as the communications hub for the MAP function, building awareness and uptake of redefined processes and best practices, keeping MAP excellence top of mind
Lead a team of four SMEs organized around system, training, digital asset management, and analytics.
Accountable for the successful modernization and maintenance of an intuitive promotional review platform (eMAP) critical to the success of the commercial organization, with significant regulatory and compliance impact.
Ensure department compliance with FDA, DOJ, and industry requirements
Drive measurable progress between business and IT - Navigate complex organization to ensure stakeholder alignment and influence without authority.
Collaborate with SMEs and MAP Leads to measure, design, and continuously improve the infrastructure of MAP.
Define short and long term IT roadmap, develop system release process, and quality assurance requirements.
Re-engineer workflows and work practices to improve throughput time with consideration to risk and industry requirements.
Established training vision and strategic approach, aligning curriculum to objectives
Data retention point of contact - establish data management plans, migration strategies, and archive capabilities
Oversee the quarterly insights reporting processes, evaluating trends to communicating areas of opportunity to key stakeholders
Triage investigations and inquiries to ensure adequate and timely response, assist in identifying root cause and implementing preventative action plans
Proactive vendor managementKey Performance Indicator :
Execution of the MAP transformational plan related to communications, systems & training
Compliance with all regulatory obligations and Novartis policies
Quantifiable operational modernization, simplification and agility
Ongoing performance evaluation and assessment with demonstrated continuous improvements.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Education (minimum / desirable) : BA / BS degree in Business, IT Systems, Science, Marketing, or Communications. Experience / Professional requirement :
Minimum of 5 years’ experience in pharmaceutical industry
Working knowledge of FDA and Pharmaceutical regulatory and compliance guidelines on advertising and promotion
Exceptional technical expertise in SaaS-based Integrated Marketing Management platforms (Veeva, Zinc, Aprimo, DAM systems)
Business systems and / or sales / marketing operations leadership
Understanding of pharmaceutical review and approval process (MAP)
Demonstrate persistent follow through and ability to juggle shifting priorities with ease
Strong collaboration, communication and negotiating skills
Strong leadership, motivation skills with ability to influence without direct responsibility
Exceptional project and process management experience
Results-oriented ability to deliver under tight deadlines
Proficiency in computer applications, including Microsoft Office, Adobe Acrobat, and in Integrated Marketing Management platforms (Veeva, Zinc, Aprimo, DAM systems)
Ability to train, coach, and lead others
Comfortable presenting to small and large groups