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Medical Director, US Medical Affairs - Infectious Diseases 5/25/2018

Shionogi Inc Florham Park, NJ

Location
Florham Park, NJ
AJE Ref #
581946499
Job Classification
Full Time
Job Type
Regular
Experience
Mid-Career (2 - 15 years)

JOB DESCRIPTION

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This Medical Director, US Medical Affairs will provide medical/scientific support to the Shionogis various personnel by functioning as the medical subject matter expert on the companys various cross-functional teams. The incumbent will have primary responsibility for Infectious Disease products with the flexibility to expand into other product areas as Shionogi Inc. continues to expand.

DUTIES AND RESPONSIBILITIES
Provide oversight and medical sign-off on all relevant product messages and copy by utilizing medical expertise and insight to develop and substantiate claim support.
Responsible for making medical-opinion decisions as these decisions impact the project upon which she or he is involved.
Provide medical oversight and input to various marketing projects and initiatives, including the development of marketing materials and planning and implementation of strategic marketing activities.
Provide support and medical expertise to Company documents to ensure scientific accuracy including the development of educational materials, and the monitoring of published literature.
Assist the VP, US Medical Affairs with establishing and achieving medical affairs-related strategic goals and objectives.
Participate in tactical and strategic project teams; collaborate with the drug safety team members to optimize pharmacovigilance activities, including evaluation of reports of spontaneous and clinical adverse events and monitoring of product labeling.
Assist in the selection of outside experts and maintain productive relationships with key opinion leaders in areas relevant to the Companys business.
Assist the Clinical Research team in the planning and review of Clinical Research programs, protocols and final study reports for clinical development projects, as well as in Clinical Research programs needed for the support of existing products and claims.
Participate in early stage project planning, and recommend the most appropriate medical input for project development plans. Conduct early opportunity assessments and assist with regulatory submissions.
Facilitate adherence to ICH, pharmacovigilance and GCP guidelines through the development and maintenance of applicable Company Standard Operating Procedures.
Maintain effective working relationships with development, legal and marketing colleagues.
Maintain effective relationships with external experts/consultants to provide scientific support to the Companys business initiatives
Participate in the Grant Reviews and Advisory Committees as needed / requested.
Will work as an individual contributor; with potential supervisory responsibilities as department growth continues.
Will travel to interact with field based individuals domestic and international.

MINIMUM JOB REQUIREMENTS
M.D. or D.O. with an Internal Medicine background, or PhD or PharmD.
Must offer experience dealing with infectious diseases.
A minimum of 3-5 years of Medical Affairs experience in a pharmaceutical company with a focus on Infectious Disease; with antibiotic/antiviral drug development experience would be a plus.
Prior Clinical Development experience with a focus on Infectious Diseases is ideal.
Strong interpersonal, communications and presentation skills. Ability to effectively communicate with employees at all levels in the organization.
Experience interacting with Field Sales; MSLs and KOLs.
Experience strategizing and overseeing development of publications and scientific communications.
Willing to be flexible with regard to specific product responsibility as the size and structure of the Company changes. Should be adaptive to working in other therapeutic areas as deemed necessary.

To be considered for this position, send email to dpodell@shionogi.com -- or apply online at: https://www.shionogi.com/careers/careers.html -- We look forward to reviewing your resume & qualifications.