Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company. We are in a unique position of having the financial backing and the research capabilities of a well-established leading Japanese pharmaceutical company,
matched with the entrepreneurial spirit of a start-up company.
Shionogi Inc. develops and commercializes pharmaceutical products that address unmet medical needs in the areas such as pain, women s health and anti-infectives. Together with our Japanese corporate parent, Shionogi has been providing innovative medicines
essential to people's health for over 130 years.
We are seeking dynamic, focused and creative individuals to join our growing team. We are currently expanding our workforce in our New Jersey headquarters location and looking for experienced pharmaceutical professionals to help us build for the future.
This Medical Director, US Medical Affairs will provide medical/scientific support to the Shionogi s various personnel by functioning as the medical subject matter expert on the company s 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 Company s 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 Company s business initiatives
- Participate in the Grant Reviews and Advisory Committees as needed / requested.
- Will work as an individual contributor; with potential supervisory responsibilites as department growth continues.
- Will travel to interact with field based individuals domestic and international.