Medical Writer

Medical Writer - IA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.This is a contract position with my direct client.Job DescriptionOverview:The Medical Writer Specialist is responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the Client Strategic Medical Affairs Team for a wide range of audiences.Key Job Activities:Primarily focuses on preparing, writing, editing, and reviewing regulatory documents and responses to regulatory authorities.Participates in post-market surveillance activities by conducting routine systematic literature reviews for specific medical device groups or sub-groups.Performs scientific writing such as abstracts, manuscripts, presentations.Organizes and incorporates information for documents, such as references, graphics, tables, and data listings.Ensures documents are produced in accordance with procedures, internal and external guidelines, and electronic templates.Ability to quickly acquire understanding of therapeutic areas, medical device portfolios, business objectives, clinical data/evidence.Independently, critically writes and edits scientifically complex documents for substantial intellectual content.Reviews and provides input on clinical data being considered for presentation and/or publication to ensure alignment with scientific strategies and corporate goals.Expert knowledge of clinical research, device/drug development processes, regulatory requirements, good clinical and data management practices.Ability to understand and interpret statistical results of clinical studies; specifically summarize complex results and present them in clear, concise, and scientifically accurate manner to various end users.Communicates with various departments to identify the necessary clinical and technical information.QualificationsJob QualificationsPh.D/Pharm D plus 1 to 2 years of related medical device/drug industry experience (e.g. medical writing, regulatory affairs, clinical research, engineering)BS/B.Pharm/BSN or MS or MPH plus 4 to 5 years of relevant medical device/drug industry experienceKnowledge/RequirementsExcellent English language skills, especially writing and proofreading.Clinical, scientific or research background, highly preferred.Experience writing CERs, highly preferred.Knowledge in narrative or systematic literature reviews, highly preferred.Experience in medical writing or demonstration in scientific writing ability in accordance with International Committee of Medical Journal Editors (ICMJE) authorship guidelines, preferred.Expert understanding of scientific or clinical research and methods.Understanding of statistical data and good data management practices.Strong oral communication, presentation, project management and prioritization skills.Excellent interpersonal relationships.Highly proficient in Microsoft Office Suite and bibliographic software (e.g. Endnote, Reference Manager).Additional InformationContact me at View phone number on click.appcast.io