Associate Director, Medical Advisor

Band

Level 5

 

Job Description Summary

Novartis has an incredible opportunity for a talented individual to join our team as a Medical Affairs Associate Director, Medical Advisor. As the Associate Director, Medical Advisor you will provide a high-quality review of US promotional materials involving Novartis divisions, the Medical Advisor must be able to ensure materials are scientifically accurate, current, and properly substantiated and referenced. Ensure material is scientifically rigorous and presented with necessary context to allow appropriate interpretation of data and ensure material is scientifically understandable for intended US customer audience and aligned with the informational requests of US health care professionals.

The ideal location for this role is at the East Hanover, NJ site but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to specific site for periodic live meetings will be at the employee’s expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 20% travel.

 

Job Description

Key Responsibilities:

• Provide high-quality medical review of promotional (and non-promotional materials as needed); ensure materials are scientifically accurate, current, and properly substantiated and referenced; ensure materials are scientifically rigorous and presented with necessary context to allow appropriate interpretation of data and supported by the broader US clinical landscape/practice.
• Collaborate with cross-functional teams (field medical, publications, scientific communications, medical directors, HEOR, regulatory, legal, HCP engagement team) to ensure tactics are aligned with the strategies identified for the Innovative Medicines portfolio (e.g., medical strategy teams [MSTs] and launch management teams [LMTs]).
• Consistently demonstrate agility and flexibility by being readily available to collaborate with US brand, MLR team, and other key cross-functional stakeholders during normal US business hours in order to address any pressing needs for key deadlines or priorities
• Readily available to attend and present at MAP meetings
• Consistently collaborate and align with TA medical director on key marketing materials
• Identify emerging medical trends, marketplace issues (e.g., Medical Inquiry Trends, Business Intelligence) and quality assurance issues and share with appropriate Novartis personnel.
• Provide timely advisory support for responses to unsolicited medical information inquiries/requests from HCPs in a multi-media environment and record information according to Novartis and regulatory guidelines.
• Provide strategic input on medical response document development and approve medical response document to address unsolicited medical HCP inquiries as needed.
• Collaborate across IMUS Medical Affairs, Marketing, Sales functions, in order to ensure alignment of clinical information strategy with business needs.

Essential Requirements:

• PharmD, healthcare-related PhD, or MD is required with significant industry or related medical information/medical review experience preferred. Post-graduate specialty training is desirable.
• A minimum of 5 years of experience in US promotional review (DTC/consumer marketing, market access, HCP materials) in addition to extensive experience in biostatistics, CFL guidance, OPDP/FDA regulations regarding clinical data and medical promotion, medical writing, medical information/drug information, and/or relevant clinical experience.

• Strong knowledge of medical terminology, biostatistics, clinical trial design, pathophysiology, pharmacology, pharmacotherapeutics, and laboratory diagnostic tests.
• Proven literature analysis and evaluation skills. Strong understanding of English language needed to help assess nuances of claims.
• Excellent communication skills with strong business acumen needed to work with various challenging stakeholders to be solution oriented
• Flexibly working during US business hours to ensure business continuity and immediate action as required.
• Strong understanding of regulatory and clinical landscape to provide sound risk assessment for material review
• Proficient in Microsoft Word, PowerPoint, Excel, and technologically savvy.

Desirable Requirements:

• Advanced degree or training in particular relevant therapeutic area desirable.
• Knowledge of drug information processes and adverse event reporting regulations is strongly preferred
• Pharmaceutical Industry Experience preferred

Novartis Comp