Sr. Medical Writer

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $5+ billion in sales, 20,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.

Job Summary

Combining knowledge of science with the understanding of research, the Sr. Medical Writer will support the development and creation of clinical and scientific documents to present information effectively, with clarity and in accordance with procedures and corresponding regulations. This includes conducting literature reviews, assisting and writing Clinical Evaluation Plans and Reports for submission to regulatory bodies, and various activities including abstracts and manuscripts in alignment with the core business strategy. 

 

The Sr. Medical Writer will act as the primary contact for medical writing projects, cross-functionally with Terumo entities and customers to set and met internal and external deliverables and will develop and maintain core competence related to medical aspect of the devices produced and/or distributed buy Terumo Medical. In working cross-functionally, will collaborate with internal stakeholders, to include Clinical Affairs, Professional & Clinical Education, Regulatory Affairs, Quality Systems, Marketing, Sales as well as external stakeholders, to include FDA, NB, PMDA, KOL, HCP, IRB and publishers.

Job Details/Responsibilities

• Collaborate with the team of clinical operation, performing with significant autonomy, to write clinical documents for regulatory submissions, including but not limited to: 
• Conduct literature searches, manage the literature database and prepare literature reviews for external and internal clients Medical literature analysis reports.
• Write clinical evaluation reports (CEP, LRP, LRR, CER).
• Contribute to Hazard/Harm list creation as a part of Risk Management per product.  
• Research, create, and edit assigned clinical reports, documents and scientific presentations in cooperation with the Clinical, Medical, & Regulatory Affairs Teams, Key Opinion Leaders and physician investigators.
• Assist in the creation of clinical educational materials for the global Sales & Marketing organizations. 
• Contribute to development and review of risk and benefits of Terumo devices.
• Create and/or review product claims based on the existing clinical and nonclinical evidence.
• Study (summary) protocols.
• Write investigator brochures, interim and final clinical study reports, briefing documents (including internal  summary reviews for internal and external purpose  and  Annotated papers).
• Write abstracts and manuscripts .
• Perform other job-related duties as assigned.
   

Knowledge, Skills and Abilities (KSA)

• Strong foundation and understanding of Quality System Requirements.  
• Strong verbal, written, and interpersonal communication skills.
• Highly proficient in using Microsoft Office applications (Word, Excel, PowerPoint) and EndNote.
• Expertise in conducting focused literature searches on PubMed, Embase, MedLine or other similar medical literature databases.
• Knowledge and understanding of PICO methodology.
• Ability to function in a self-directed manner with a high degree of independence
• Ability to evaluate data and maintain in-depth understanding of product knowledge, associated disease states, treatment guidelines, labeling, and relevant internal data for clinical/therapeutic area.
• Working knowledge of data management (e.g., data review and analysis), safety surveillance, reporting, and Health Economic and Reimbursement practices.
• Understanding of statistical principles.
• Ability to persuasively influence external medical professionals.
• Effective analytical and problem-solving skills.  
• Excellent interpersonal and effective verbal and written communication skills and effectively work across departments with diverse needs. 
• Excellent organizational and time management skills.
• Ability to adapt to changing priorities.
   

Qualifications/ Background Experiences

• Advance Degree ((Ph.D., MD, Sc.D, MA/MS or MPH) in a medical/biomedical/scientific discipline with a minimum of 3 years of scientif