Associate Manager, Medical Information - I

Description

True Title: Associate Manager, Medical Information - I

Location:  Santa Monica, CA or El Segundo, CA or Foster City, CA

Hybrid work: Need candidate to be onsite 1day/ week at Santa Monica, CA or El Segundo, CA or Foster City, CA

Job Summary

The Associate Manager, Medical Information (MI) is a key scientific resource within the Medical Affairs department.

• This role is responsible for the comprehensive and timely delivery of accurate, fair-balanced, and scientifically rigorous medical information in response to inquiries from healthcare professionals (HCPs), patients, and internal stakeholders regarding client's oncology cell therapy products.
• The individual will develop and maintain standard response documents, manage the inquiry database, and ensure all activities adhere to regulatory and compliance guidelines.

Key Responsibilities

Medical Information Response:

• Serve as a primary point of contact for external medical information inquiries (via phone, email, portal) from HCPs concerning client's products.
• Research, write, and review custom scientific responses to complex clinical and technical questions, utilizing primary literature, clinical data, and internal resources.
• Ensure all responses are accurate, compliant, and aligned with approved labeling and company policies.

Content Development & Maintenance:

• Author, update, and maintain the Global Medical Information Standard Response Documents (SRDs) and Frequently Asked Questions (FAQs) for assigned products.
• Contribute to the development of Medical Information resources, including slide decks, formulary kits, and training materials for internal teams.

Database & Quality Management:

• Accurately document all medical information inquiries and interactions in the designated CRM system (e.g., Veeva CRM) in a timely manner.
• Perform routine quality checks on MI responses and processes. Support metrics reporting and trend analysis to identify knowledge gaps and inform strategy.

Compliance & Collaboration:

• Operate in strict compliance with all regulatory (FDA, OPDP), legal, and corporate guidelines (e.g., PhRMA Code, SOPs).
• Collaborate closely with cross-functional partners, including Medical Science Liaisons (MSLs), Clinical Development, Drug Safety, Regulatory Affairs, and Commercial teams (within compliance guardrails).
• Support the review of promotional and educational materials for scientific accuracy as needed.

Special Projects & Intelligence:

• Participate in special projects, such as supporting congress activities, system updates, or process improvements.
• Monitor medical inquiry trends to provide insights on emerging HCP/patient needs and potential issues to Medical Affairs leadership.

Qualifications & Experience

Required:

• Advanced scientific/clinical degree (PharmD, PhD, MD, or Master's in a life sciences field) is highly preferred.
• BSN/PA with extensive relevant experience may be considered.
• Minimum 1-3 years of experience in the pharmaceutical/biotech industry, with a strong preference for experience in Medical Information, Medical Affairs, or Clinical Pharmacy. Experience in Oncology, Hematology, or Cell/Gene Therapy is a significant plus.
• Demonstrated ability to critically analyze and synthesize complex scientific literature and clinical data.
• Excellent medical writing and verbal communication skills, with the ability to translate complex data into clear, actionable information.
• Strong understanding of US regulatory requirements for Medical Information and promotion (e.g., FDA guidance, OPDP).
• Proficient with medical literature databases (PubMed, Embase) and CRM systems (e.g., Veeva).

Preferred:

• Direct experience in CAR-T or cell therapy.
• Experience with global or regional MI processes and systems.
• Proven project management and process improvement skills.
• Ability to work effectively in a fast-paced, cross-functional matrix environment.