Critically review promotional and medical materials in compliance with corporate standards and government/industry regulations
Determine if promotional messages and medical statements are appropriately supported by data
Act as the Technical/QC Medical Reviewer by fact-checking all claims and performing detailed reference checking
Remain current on regulations and best practices within the industry
Maintain ongoing communication with Medical Leads to ensure materials are aligned to medical strategy
Demonstrate knowledge of disease area, product labeling, and regulatory guidance
Maintain therapeutic area and product knowledge through ongoing assessment of relevant literature, treatment guidelines, and internal and external data sources
Conduct literature searches in order to ensure that the most current and appropriate literature is cited in the materials
Support the development and updates of Medical Information Standard Response Letters (SRLs), Frequently Asked Questions (FAQs), and other Medical Information materials in order to ensure complete, accurate, balanced, and referenced materials are available to respond to unsolicited requests for scientific information in a timely manner
Support the development and updates of scientific Medical Affairs materials (e.g., decks, clinical trial flyers, medical exhibit materials, etc.)
Support the development of regulatory compliance processes, including training documents, standard operating procedures, work instructions and other supporting process documents
Support completion of quality review of medical information cases and, as necessary, ensure correction and provide feedback/retraining
Support handling of inquiries escalated to the internal Medical Information department by providing timely responses to unsolicited inquiries
Assist in recognizing, collecting, and ensuring the appropriate forwarding of safety/adverse event and/or product quality information according to FDA guidelines and company policies
Attend external medical conferences and staff the Medical Affairs booth as needed

Requirements

PharmD, PhD, MS, BS, or other clinically oriented healthcare-related degree with appropriate experience
2+ years of experience in working in a Medical Review role in the pharma industry
2+ years of experience in scientific/medical literature identification and evaluation
1+ years of experience in medical writing
Experience with Microsoft products and familiarity with Veeva Vault preferred
Solid tumor oncology experience preferred
Product launch experience preferred

Benefits

medical, dental, and vision insurance
401(k) retirement savings plan
generous paid time off (including a summer and winter company shutdown)
comprehensive benefit package to support employees

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

medical reviewscientific literature evaluationmedical writingregulatory compliancefact-checkingdata analysisquality reviewliterature searchtherapeutic area knowledgeproduct labeling

Soft Skills

communicationattention to detailcollaborationcritical thinkingorganizational skillsproblem-solvingadaptabilitytime managementfeedback provisiontraining

Certifications

PharmDPhDMSBS