This role supports the US region and therefore requires full coverage during US Eastern Standard Time (EST) business hours. The expected working hours are from 14:00 – 22:00 GMT/CET -1.

There may be times that you may need to be working or in the office for local events such as townhalls, visitors etc. In this case, you will be required to work flexibly which may result in an earlier start & finish time. 

Major accountabilities:

(include but are not limited to)

• 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.

Minimum Qualifications/ 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
• Pharmaceutical Industry Experience preferred; At least 3 years (manager level) or at least 5-7 years (AD) 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.
• Advanced degree or training in particular relevant therapeutic area desirable.
• Strong knowledge of medical terminology, biostatistics, clinical trial design, pathophysiology, pharmacology, pharmacotherapeutics, and laboratory diagnostic tests.
• Knowledge of drug information processes and adverse event reporting regulations is strongly preferred
• Proven literature analysis and evaluation skills. Strong understanding of English language needed to help assess nuances of claims.
• Excellent communication skills (strong US English language preferred) with strong business acumen needed to work with various challenging stakeholders to be solution oriented
• Strong understanding of regulatory and clinical landscape to provide sound risk assessment for material review
• Proficient in Microsoft Word, PowerPoint, Excel, and technologically savvy.
• Employees are typically expected to be in their current role for at least 12 months before applying for a different role. This allows them to gain sufficient experience and demonstrate their capabilities in their current position. Any transfer or application for a different role typically requires approval from the employee's current manager and the leadership team. 

The preceding statements are intended to describe the general nature and level of work being performed by people assigned to this job.  They are not intended to be an exhaustive list of all responsibilities, duties, and skills required.