
Senior Scientific Consultant
3 days ago
We are seeking a highly skilled Medical Advisor to join our team. This role involves providing high-quality review of promotional materials, ensuring they are scientifically accurate and up-to-date.
The Medical Advisor will work closely with cross-functional teams to ensure that tactics align with the overall strategy for the portfolio.
This is a challenging and rewarding role that requires strong analytical and communication skills, as well as a deep understanding of the regulatory landscape.
About The RoleThis is a full-time position that requires full coverage during business hours in the US Eastern Standard Time zone.
The expected working hours are from 14:00 – 22:00 GMT/CET -1.
There may be times when flexibility is required, which may result in earlier start and finish times.
Key ResponsibilitiesProvide high-quality medical review of promotional (and non-promotional) materials as needed; ensure materials are scientifically accurate, current, and properly substantiated and referenced.
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 portfolio.
Demonstrate agility and flexibility by being readily available to collaborate with stakeholders during normal US business hours to address pressing needs for key deadlines or priorities.
Readily available to attend and present at meetings.
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 personnel.
Provide timely advisory support for responses to unsolicited medical information inquiries/requests from healthcare professionals in a multi-media environment and record information according to guidelines.
Provide strategic input on response document development and approve response documents to address unsolicited medical inquiries as needed.
Collaborate across functions to ensure alignment of clinical information strategy with business needs.
A PharmD, healthcare-related PhD, or MD is required with significant industry experience preferred.
At least 3 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.
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 with strong business acumen needed to work with various stakeholders.
Strong understanding of regulatory and clinical landscape to provide sound risk assessment for material review.
Proficient in Microsoft Word, PowerPoint, Excel, and technologically savvy.
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