Associate Director, US Medical Promotional Review Scientist, Neuroscience
Core
Ensure medical accuracy and scientific validity of promotional and non-promotional materials for Neuroscience brands while maintaining compliance with US laws and regulations.
Role type
Senior individual contributor medical review scientist (Associate Director level)
Builds
Medically accurate promotional content and compliant labeling for Neuroscience medicines
Domain
Pharmaceutical industry, Neuroscience
Required skills
Medical writing, Promotional review, Therapeutic area knowledge, FDA/OPDP guidance, Clinical guidelines, Evidence evaluation, Stakeholder management, Strategic leadership, Project management, Data interpretation
Preferred skills
PharmD/PhD/MD, Real World Evidence, FDAMA 114 content, Digital/AI-driven solutions, Change management
Technologies
FDA/OPDP guidance, Clinical guidelines, Digital tools, AI-driven solutions
Responsibilities
Review promotional and non-promotional materials for scientific validity and regulatory compliance; Provide medical guidance in interdisciplinary meetings; Evaluate evidence supporting promotional claims; Align with marketing, legal, and commercial regulatory affairs; Lead process improvements in medical review activities; Advise on draft product labeling.
Seniority
Senior, strategic leadership with hands-on review