This role is based in Mexico City, Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. 

 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 IM Medical Affairs, Marketing, Sales functions, in order to ensure alignment of clinical information strategy with business needs.

Essential Requirements:

• Advanced English, level C1 – C2
• Candidate must have 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. 
• Bachelor’s degree, 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.

• 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 

• 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. 

Commitment to Inclusion  

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.  

Novartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to tas.mexico@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.