Senior Specialist Global Medical Info and Medical Review

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

• Medical Review

• • Serves as a medical reviewer on the Promotional Review Committee (PRC) for assigned product

  • Serves as the coordinator and a medical reviewer on the non-promotional Medical Review Committee (MRC)

  • Reviews materials for scientific accuracy, balance/comprehensiveness, substantiation with appropriate references, and appropriateness of language based on audience.

• Inquiry/Case Management

• • Handles unsolicited inquiries for information that are escalated from the GMI Call Center or received directly from a wide range of requestors, including healthcare professionals (HCPs), Payers, patients, and caregivers.

  • Takes appropriate, compliant, and timely action based on the specific request, which includes providing responses, reporting of adverse events or complaints, or triage to another department.

  • As needed, evaluates trend analysis on medical inquiries of assigned product/therapeutic area

• MI Content Development

• • Create, update, and review Scientific Response Documents (SRDs) and other types of MI response materials with up to date and relevant information based on

  • Create, update, and review Custom Response Documents (CRDs) as needed

  • Conducts thorough and accurate searches within the medical literature database and selects relevant literature for inclusion in response documents.

  • Adhere to GMI Style Guide, templates, and overall compliance parameters.

• Adhere to GMI Style Guide, templates, and overall compliance parameters.

• Adhere to GMI Style Guide, templates, and overall compliance parameters.

Required:

• Advanced scientific degree such as PharmD, Ph.D. or similar level

• 1-3 years of experience in a Medical Affairs environment with direct experience in Medical Information/Medical Review preferred.

• 1-2 years of clinical/practical experience in a relevant clinical or pharmacy environment Knowledge of applicable FDA regulations and guidance for related workstreams is preferred.

• • Excellent writing skills including attention to detail, grammar

  • Adequate scientific knowledge with the ability to search/evaluate published medical literature and absorb new information to arrive at an accurate understanding of a given topic, or inquiry.

  • Excellent verbal communication skills to engage in effective dialogue with internal/external stakeholders.

  • Ability to multitask by prioritizing deliverables based on business need.

  • Comfortable and capable of using software programs (Word, Excel, Power Point, Outlook, etc.) and a willingness to increase these competencies.

  • undefined

  • Experience using these systems preferred:

  • • Information Request Management System (IRMS)

    • Veeva MedComms and PromoMats