Comrise Inc. Project Manager - Jr. in Fremont, California
Provides advanced scientific writing expertise for multiple projects in all therapeutic areas. Interfaces with other functional area teams (e.g. , Regulatory, Biostatistics and Data Management, Clinical Affairs, Medical Affairs, Medical Communications, Marketing), ensuring successful preparation of high quality submission-ready documents and marketing medical material.
Serves as the scientific writing content expert for the department.
Evaluating data for similar competitor devices. Screening and summarizing literature for relevant clinical data. Ensuring timely production of high quality CERs for devices across therapeutic areas as well as MPCF plans, CEPs and other relevant documents.
Must meet the following requirements for consideration: Willingness to travel to the Fremont office up to 1 time a month. Experience across document types and therapeutic areas/diseases. 1-2 years of regulatory writing experience, with some exposure to medical devices. A MD, PhD in Biomedical Engineering or similar degree preferred, a Master's degree with clinical research exposure required. 5+ years of CER writing experience in a medical device company, CRO, or agency. Advanced knowledge of 510(k), MedDEV 2.7.1 Rev 4, MDR, and other relevant medical device regulations.
External Company Name: Comrise
External Company URL: www.comrise.com
Street: Bayside Parkway