Working under the supervision of the Global Head of Name Creation and Regulatory Strategy (NCRS), and/or designees, assist with all aspects of proprietary (brand) name development..
You will play a critical role in the creation and clearance of new patient-centric pharmaceutical product/drug names and contribute to the name safety evaluation process to support safe prescribing throughout the medication use process.
More specifically, you will:
• Provide all aspects of project management support for NCRS-related global and regional pipeline products.
• Support both global and regional business objectives of the brand, while ensuring adherence to legal processes and requirements through interpretation and adherence to regulatory guidelines.
• Interact and collaborate Intellectual Property, Clinical, Regulatory Affairs, Marketing (Name and Logo), Pharmacovigilance, Adverse Drug Reactions, Product Information/Medical Affairs, and Clinical Trials.
• Supporting project management for:
o assigned projects and co-lead NCRS sub-teams as assigned across the company's therapeutic areas and functions like project activation
o meeting planning and preparation of all presentation materials
o vendor management
o team communications
o updates and minutes
o assisting in recommendation & approvals process
• Contributing to all aspects of NCRS work involving Medication/Patient Safety
• Reviewing and analyzing name safety research
• Contributing to EMA/FDA and other proprietary name submission documents and appeals
• Leading FMEA analysis when required
• Providing ad-hoc support on a variety of trademark-related topics
• Creating customized PowerPoint, Excel, and Word documents as needed
Why consider Novartis?
750 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.
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.
What you'll bring to the role:
• PharmD Degree required.
• Experience in Medication Safety such as a certificate from a Medication Safety track or program is preferred
Experience and Skills:
• 1-3 years if experience is preferred; will consider recent PharmD Fellow graduate with Medical Safety or other relevant track.
• Prior knowledge or experience with FDA Guidance and nomenclature review on Proprietary names preferred.
• Knowledge of pertinent regulations (e.g. US/EU/Global trademarks-related) and how they are applied and their implications is preferred.
• Excellent communication skills (listening, verbal, written, and presentation) are required to work effectively with various Internal & External stakeholders.
• Strong ability to collaborate effectively across other business units and multidisciplinary initiatives is required.
• Ability to manage relationships with multiple partners with divergent objectives.
• Independent, self-driven, enthusiastic, and a strong team player