Director, Medical Information & Compliance Lead

ELKA Search Partners; Philadelphia (Philadelphia County); On-site; USD 170,000 - 230,000; Full time

Job summary

ELKA Search Partners is seeking an experienced Director, Medical Information to lead the Medical Information function for a growing clinical-stage biotechnology company in the greater Philadelphia area. The role requires four days per week on-site and coordination across Medical Affairs, Commercial, Regulatory, Legal, Pharmacovigilance, Clinical Development and Quality.

The ideal candidate will oversee external partners, ensure timely, accurate and compliant scientific information, and drive

Qualifications

• 8+ years of pharmaceutical or biotechnology industry experience, including significant Medical Affairs/Medical Information experience.
• Experience developing Medical Information response documents and managing complex inquiries.
• Experience reviewing promotional and scientific materials with compliance knowledge.
• Strong scientific judgment and ability to translate clinical information into clear responses.

Responsibilities

• Lead the Medical Information function and oversee outsourced call center vendors.
• Develop and maintain Medical Information processes, SOPs, and governance documents.
• Draft and approve standard response letters and scientifically accurate materials.
• Manage complex inquiry escalations and route adverse events and other reportable information appropriately.
• Serve as Medical reviewer for promotional/scientific materials in collaboration with multiple functions.

Skills

Medical Information

Pharma/Biotech experience

Regulatory compliance

Scientific communication

Education

PharmD/PhD/MD or equivalent

Job description

ELKA Search Partners is seeking an experienced Director, Medical Information to lead the Medical Information function for a growing clinical-stage biotechnology company in the greater Philadelphia area. The role requires four days per week on-site and coordination across Medical Affairs, Commercial, Regulatory, Legal, Pharmacovigilance, Clinical Development and Quality.

The ideal candidate will oversee external partners, ensure timely, accurate and compliant scientific information, and drive