Medical Review Manager

Xeris Pharmaceuticals•Chicago, IL

2d•$120,000 - $175,000•Hybrid

About The Position

The Medical Review Manager is a key member of the Medical Communications team, Medical Affairs organization, and contributes to overarching Medical Affairs initiatives, including strategy, launch activities, and operations. This individual’s primary responsibilities are to provide advanced medical and scientific review of: 1) promotional materials, press releases, and sales training communications to support the promotional review process, 2) medical and scientific medical materials, and 3) other pertinent publications in the therapeutic areas, and serve as a resource to other colleagues as needed. This role will coordinate with Medical Affairs colleagues, vendors, and outsource providers (as needed) to review content to be disseminated via multiple communication channels. This individual will create, maintain, and communicate metrics and key performance indicators to Senior Leadership. This role will regularly interact with internal and external key stakeholders on publication and medical communication activities across compounds. This individual will participate in assigned Medical Affairs, Leadership, and Cross-Functional meetings and initiatives as assigned.

Requirements

The qualified candidate will have a doctoral degree in a health sciences-related field such as a PharmD, MD, or PhD, with a thorough grasp of the pharmaceutical industry.
2-3 years of healthcare or related experience (managed markets, clinical practice, research, or academic) following award of doctoral degree including a minimum of 2 years of medical communications experience within the pharmaceutical industry.
Possesses advanced communication skills, both oral and written, and able to engender trust and respect of peers, subordinates, and superiors.
Well-versed in highly technical and scientific languages to communicate with Medical Affairs, Regulatory Affairs, Legal, Compliance, Commercial, Research and Development, as well as other key stakeholders.
Firm understanding of the drug development process, including key phases, processes, and techniques utilized for both pre- and post-marketing research studies.
Proven track record of teamwork, leadership, timely decision making, and results orientation in meeting objectives.
Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Outlook.

Responsibilities

A standing member of, and active contributor to, the Medical Review Process (MedRP) for medical materials and the Material Approval Process (MAP) for promotional materials.
Utilizing advanced clinical expertise, provide high quality review and approval of medical and scientific information autonomously, including Medical Information Standard and Custom Response Letters, Clinical Dossiers, FAQs, and other documents as identified or requested to both internal and external customers.
Lead medical review for all product promotional activities to ensure accuracy, balance, and compliance with FDA guidance and regulations, internal policies, and established medical review standards, in close collaboration with cross-functional colleagues in Regulatory Affairs, Legal, Compliance, Marketing, and Training.
Grant formal approval via signature authority for the cross-functional promotional review activities including: 1) providing strategic scientific consultations on brand messages, 2) reviewing promotional materials for content and accuracy, 3) coordinating the development, review, and approval of clinical data on file to support promotional claims.
Maintain expert knowledge of Xeris products, disease states, treatment guidelines, scientific literature, and competitive landscape; provide subject matter expertise to internal stakeholders with up-to-date clinical information to support informed clinical and business decisions.
Critically evaluate scientific literature and interpret data to support promotional messages; proactively identify potential risks and propose mitigation strategies; clearly communicate review decisions and scientific rationale to cross-functional colleagues.
Compile highlights and metrics to contribute to quarterly outcomes reports for Senior Leadership.
Coach and mentor interns or other team members as identified
Develop and deliver materials for ongoing training of departmental colleagues and others as identified.
Medical review of other materials as required.
Proactively identify and develop strategies and initiatives that improve and streamline current processes with Medical Affairs to improve medical review with internal and external customers.