(US-Illinois) For more than a century, our client has been working to advance health care for people around the world. They have evolved into a diversified health care company that discovers, develops, manufactures and markets innovative products and services that span the continuum of care from prevention and diagnosis to treatment and cure. They provide total integrated solutions across the health care spectrum for some of the worlds most prevalent medical conditions, including AIDS, cancer and diabetes. Our client, a major pharmaceutical company in Lake Forest, IL is looking for a Medical Writer III with the following qualifications: REQUIRES 5+ YEARS OF EXPERIENCE. Prepares technical documents to support both domestic and international regulatory submissions. Incorporates text, graphs, charts, tables and statistical analysis. Proofreads, circulates, edits, assembles, inspects and duplicates product submissions. Prefer PharmD, PhD, or Masters in a life science. Must have experience with writing clinical study reports. Would prefer candidates that have experience writing to ICH guidelines. Software used will be Microsoft Office (Mostly in Word, some Excel or PowerPoint). Will consider candidates with less than 5 years of writing experience, however they must have a strong clinical background. This position will require 40 hours a week of in-house writing - Telecommuting is not an option. You MUST meet all of the above qualifications in order to be considered for this position. You MUST be either a US Citizen or a Green Card Holder in order to be eligible for this position.
(US-Illinois) For more than a century, our client has been working to advance health care for people around the world. They have evolved into a diversified health care company that discovers, develops, manufactures and markets innovative products and services that span the continuum of care from prevention and diagnosis to treatment and cure. They provide total integrated solutions across the health care spectrum for some of the worlds most prevalent medical conditions, including AIDS, cancer and diabetes. Our client, a major pharmaceutical company in Lake County, IL is looking for a Clinical Medical Reviewer / Safety Reviewer - C with the following qualifications: REQUIRES 5+ YEARS EXPERIENCE Responsibilities include medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings. May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies. Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database. Off-label information would be disseminated at this level. May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification. BS Preferred. This position is for 2 days per week. Client is flexible on the days that are chosen to work. Candidate must have strong experience in the medical field. Prefer candidate that has worked in clinical setting. You MUST meet all of the above qualifications in order to be considered for this position. You MUST be either a US Citizen or a Green Card Holder in order to be eligible for this position.
(US-California-Santa Barbara) A leading BioTech company is seeking Medical Affair's professionals of all levels: Training positions up to Sr. Management. If you are interested in pursuing new opportunities with in Medical Affairs/ Communications/ Clinical Trials, please contact me at your earliest convenience for further discussion.
