Lead, Material Approval ProcessStrategy & Operations Team
Novartis AG
Switzerland, CH
vor 13 Tg.

Job Description

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.
  • EEO Statement

    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.

    Minimum requirements

    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
  • Regular

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