~~~Please note: This is a temporary contractor opportunity at Novartis ~~~
Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life!
Novartis US partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit www.magnitglobal.com
Ready to work with/through Magnit at Novartis? Please read on...
Associate Director, Content Approval \& Process Governance
Drive content approval in an agile process methodology, manage risk, and ensure operational effort will deliver value to our customers. Effective process governance is essential in this role, ensuring all submissions are monitored and aligned with organizational standards. The Content Approval Process encompasses the forecasting, planning review, release, and lifecycle management of non-promotional and promotional materials through strategic collaboration with TA leads, medical teams, legal, and regulatory (MLR) stakeholders. Emphasizing governance ensures adherence to all SOP \& Guideline requirements and maintains the highest quality and consistency of submitted materials. Furthermore, support congress activities and product launches by ensuring materials are reviewed in a timely manner and oversee the entire approval process to guarantee seamless execution.
Major Activities
• Compliance and Governance Excellence: Ensure adherence to all regulatory and compliance standards by overseeing the governance framework. Lead and implement best practices to guarantee that all processes and content are continually aligned with the latest industry regulations, while fostering a culture of integrity and accountability across all teams.
• Partnering with 3rd Party Medical Approval Agency: Conduct weekly calls with the agency team to address system issues, submission trends, and tracking of turnaround time reports, specifically the 48-hour medical approvals. Provide detailed audit trail reports for reviews outside of the 48-hour turnaround window and offer guidance for the onboarding of new brands and therapeutic areas (TA’s).
• Content Approval Process Excellence: Drive the effectiveness of the Material Approval Process through upstream, in-stream, and downstream oversight and collaboration. Lead prioritization activities for key milestones and events to prevent a backlog of materials through the end-to-end process, proactively advising to remove any potential barriers.
• KPI’s: Share metrics with stakeholders and ensure assets submitted adhere to NVS Content Approval SOP guidance. Ensure efforts are aligned to organizational priorities with increased speed to market.
• Congress Excellence: Participate in congress preparation meetings to ensure alignment on the priority for content review and Global and Local Levels. Ensure resources are aligned to organizational priorities.
• Quality Assurance: Ensure adherence to all SOP process requirements. Responsible for communication of key process updates to ensure consistent execution and change adoption across all TA Teams.
• Facilitation: Manage and upskill MLR Facilitators as a main FUSE Global/International Superuser. Attend FUSE superuser bi-weekly calls and workstreams providing insights from the Global/International perspective for system enhancements. Support and upskill external agencies as system Super User and ensure process excellence.
• Continuous Improvement: Participate in workstreams designed to improve process effectiveness and optimize material lifecycle with alignment to content approval and compliance requirements. Manage increase in submission volume to achieve established operational efficiency targets. Participate in quarterly review of business metrics and performance.
• Communication Plan and System Governance: Oversee the shared inbox for Fuse International, manage all access requests and international queries efficiently. Implement the annual Global/International FUSE Communication Plan, ensuring effective communication on system releases and content approval updates through newsletters to FUSE users. Maintain and regularly update the distribution list of over 1000+ users, ensuring its accuracy and completeness.
Experience/Education requirement:
BA/BS degree or Equivalent required. Focus in Business, Marketing, Digital Media, or Communications preferred
3 years’ experience in pharmaceutical/biotech industry and/or digital marketing operations role
• Functional experience in regulatory, medical, marketing operations, sales or communications preferred
Technical Knowledge/Professional Competencies:
• Working knowledge of EFPIA Code and Pharmaceutical regulatory and compliance guidelines on advertising and promotion
• Pharmaceutical review and approval process acumen for both promotional and non-promotional content
• Basic understanding of process optimization and asset creation
• Proficiency in computer applications, including Microsoft Office, Adobe Acrobat
• Proficiency in MLR process and systems, including but not limited to Aprimo or similar DAM/workflow and/or other channel execution applications; Veeva
• Exceptional facilitation skills to drive consensus quickly in a progressive, change intensive environment
• Risk identification, mitigation, and management skills
• Strong project and process management
• Results-oriented ability to deliver under tight deadlines
Location: East Hanover, NJ (Hybrid)
Pay Rate: $65.51 to $86.80/hr based on experience and qualifications (W2 Only)
Contract: 12-month
Health, dental, vision, 401k
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accommodation:
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries Magnit at directsourceproteam@prounlimited.com.