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.
The Clinical Research Scientist will review and interpret clinical data for query resolution by contacting clinical study site personnel including principal investigator regarding clinical data. Will also be responsible for writing, editing,
reviewing and compiling complex clinical study documents in cooperation with Global Medical Monitor and Medical Writers. Working together, they will ensure the accuracy and quality of applicable written deliverables and their compliance with ethical, legal,
regulatory, and client standards.
- Communication with clinical study site personnel including principal investigators for resolution and finalization of interpretation of data, and identification of key missing information.
- Working with Global Medical Monitor, will review and interpret clinical data through EDC and relevant database, and will draft patient narratives to a level that would be ultimately acceptable for submission for NDA applications.
- Liaise with other cross-functional internal teams (Clinical Operations, Data Management, Product Safety & Pharmacovigilance, Regulatory, Medical Writing and Project Management) to ensure timely delivery, quality of writing deliverables and problem resolution.
- Support the Global Trial Lead when participating in marketing and clinical/medical advisory panels, steering committees and investigator meetings. Serve as a resource to address medical questions or to clarify issues during conduct of the study.
- Ensure proper version control of all applicable documents.
- Define, collect, track, and report on metrics.
- Assist in the reconciliation of clinical and safety databases.
- Travel (approximately 5%) domestic and/or international.
- BSN/RN, MSN/DNP, Pharm D., or PA.
- 5 years minimum experience working in the pharmaceutical industry, a CRO or similar organization with a focus on clinical study or research activities.
- Experience with infectious disease, intensive care or pulmonology is preferred.
- Excellent written and verbal communication skills; data-interpretation skills; strong interpersonal skills; ability to plan and organize.
- Ability to communicate with clinical study site personnel including principal investigators for query resolution.
- Some medical writing experience such as authoring or co-authoring protocol, clinical study reports, investigators brochures, or patient narratives is preferred.
- Drug safety experience at a pharmaceutical company preferred.
- Knowledge of scientific and regulatory requirements as they apply to clinical studies, specifically protocols and clinical study reports.
- Ability to identify discrepancies in clinical trial data and to write queries from a medical perspective.
- Ability to independently and proactively identify potential problems; appropriately escalate and plan for mitigations to situations or issues within a study, program or key initiative. Must be able to collaborate to resolve issues.
- Document organization, management, and version control skills to include hyperlinking, TOC generation, and field updating.
- Excellent computer skills to include MS Word, MS Excel, MS PowerPoint, MS Outlook, and Adobe Acrobat.
- 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.