Senior Specialist Global Medical Info and Medical Review na Mallinckrodt

Job Title

Senior Specialist Global Medical Info and Medical Review

Requisition

JR000015366 Senior Specialist Global Medical Info and Medical Review (Open)

Location

Bridgewater, NJ

Additional Locations

Job Description Summary

The Sr. Specialist, Global Medical Information (SSGMI) is primarily responsible for serving as a medical reviewer on the promotional and non-promotional review committees as well as handling unsolicited requests for medical information. This position will also support the medical information (MI) content development for assigned therapeutic area.

Job Description

Responsibilities:

• 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.

 

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

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.

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  • Experience using these systems preferred:

  • • Information Request Management System (IRMS)

    • Veeva MedComms and PromoMats

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