Senior Manager, Regulatory Ad/Promo
Novartis
full-time
Posted on:
Location Type: Hybrid
Location: East Hanover • New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $114,100 - $211,900 per year
Job Level
Senior
About the role
- Provide strategic regulatory advice on advertising/promotion and medical materials to the US organization for assigned products
- Serve as a primary or secondary regulatory advertising and promotion reviewer for assigned products on Materials Approval Process (“MAP”) teams
- Liaison with OPDP regarding advertising and promotion for assigned products
- Ensure regulatory compliance while effectively managing business risks
- Maintain awareness of competitive activities by monitoring major US Medical meetings
- Collaborate with Regulatory Development colleagues to provide input to study designs or US label
- Participate/assist in US labeling negotiations and FDA meetings as necessary
Requirements
- BS Degree or equivalent
- Advanced degree desirable (MS, PhD, PharmD, or JD)
- Knowledge of drug development process
- Ability to analyze and interpret efficacy and safety data desired
- Understanding of business goals of the involved business franchise, marketing concepts and tools
- Must be able to work in a multi-disciplinary environment
- Must process strong interpersonal and communication skills
- Must have analytical and problem-solving skills associated with problem review and inquiries
- Must be able to provide creative solutions to problems.
Benefits
- health insurance
- life and disability benefits
- 401(k) with company contribution and match
- generous time off package including vacation, personal days, holidays and other leaves
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory complianceadvertising reviewpromotion reviewdrug development processdata analysissafety data interpretationlabeling negotiationsFDA meetings
Soft skills
interpersonal skillscommunication skillsanalytical skillsproblem-solving skillscreative solutionscollaborationmulti-disciplinary teamwork
Certifications
BS DegreeMS DegreePhDPharmDJD