Associate Director, Materials Approval Process (MAP) Lead job in East Hanover
|Employer:|| Novartis Pharmaceuticals|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
To lead the process and team in the review, approval, and release of customer oriented materials, collaborating with process stakeholders to ensure regulatory and Novartis standards are consistently met.
• Process Expert/Lead - Serve as the centralized "knowledge hub" of the Materials Approval Process (MAP), providing guidance to project owners on process. Evaluate material content to ensure quality and consistency of messaging at the development and review stages of projects. Serve as key contact for Reviewers, Project Owners and Agencies from concept/project initiation through final validation: leverage knowledge of MAP and A&P expertise to drive priorities, project development quality/speed and compliance. Assess materials to determine which review stage/reviewers are required.
• Business Partnering - Collaborate with Brand teams to plan and prioritize material development and review. Participate in extended Brand Team to foster relationships and provide early guidance to project owners, Drive awareness of key initiatives upfront. Train MAP teams on new processes and provide ongoing best practice sharing.
• Team Leadership/Meeting Facilitation Plan and implement effective MAP meetings by driving early planning and facilitating consensus among stakeholders. Ensure all MAP Reviewers provide clear, actionable annotations in Stage 2 live meetings and offline reviews. Provide direction to MAP Team Associate to help ensure alignment of eMAP users in understanding priorities within and across brands, and completing their tasks; delegate responsibilities as appropriate
• Quality Assurance - Ensure adherence to all MAP process requirements. Responsible for communication of key MAP process updates. Partner with POs/Agencies to ensure materials are submitted correctly; identify any areas for improvement and provide actionable feedback.
• Continuous Improvement - Lead workstream(s) designed to improve process effectiveness and optimize material lifecycle with alignment to commercial and compliance requirements.
Key Performance Indicators:
• Compliance with all regulatory obligations and Novartis policies
• Effective operational management aligned with business demands
• Material approval process effectiveness
• Critical role in the development of high quality materials to ensure consistency and compliance amongst functional areas (marketing, sales training, Med Ed, etc.).
• External satisfaction, acceptability of materials by Health Authorities
• Well managed and effective MAP teams
• Novartis seen as a credible, ethical and preferred partnerEducation:
BA/BS degree or Equivalent 4-Year degree required. Focus in Business, Medical, Science, Marketing, or Communications preferred.
• > 5 years' experience in pharmaceutical/biotech industry
• Functional experience in regulatory, medical, pharmaceutical marketing operations, sales or communications preferred.
Technical Knowledge/Professional Competencies:
• Working knowledge of FDA and Pharmaceutical regulatory and compliance guidelines on advertising and promotion
• Understanding of pharmaceutical review and approval process preferred
• Proficiency in computer applications, including Microsoft Office, Adobe Acrobat, Veeva Vault, Zinc, or Aprimo Marketing Studio (preferred)
• 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
• Strong project and process management experience
• Results-oriented ability to deliver under tight deadlines
• Willingness to train and coach others