Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company with state of the art research capabilities that has provided innovative medicines essential to people's health for over 135 years.
In the US, Shionogi Inc. develops and commercializes pharmaceutical products that address unmet medical needs in the areas such as pain and anti-infectives.
This Medical Affairs Director 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 Lusutrombopag with the flexibility to expand into other product areas as Shionogi Inc. continues to expand.
- 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.
- 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 travel to interact with field based individuals domestic and international.
- Incumbent will be responsible for making medical-opinion decisions as these decisions impact the project upon which (s)he is involved.
- Medical Doctor or a Doctorate of Osteopathy degrees or PhD/PharmD level in biologic sciences.
- 8 years minimum Medical Affairs or Clinical Development.
- Strong interpersonal, communications and presentation skills. Ability to effectively communicate with employees at all levels in the organization.
- Experience interacting with Field Sales; MSL s and KOL s.
- Experience strategizing and overseeing development of publications and scientific communications.
- Willing to be flexible with regard to specific product responsibility.
- Ability to sit for extended periods of time up to four (4) hours at a time.
- Candidate needs to be able to be adaptive to switch therapeutic areas as deemed necessary.
- Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ.
To be considered for this position, you must apply online at: https://www.shionogi.com/careers/careers.html
-- and meet the requirements of this opportunity.
We look forward to reviewing your resume & qualifications.
- We are an Equal Opportunity Employer.
- Please view Equal Employment Opportunity Posters provided by OFCCP here.