Job Description

Join to apply for the Medical Writer role at Randstad Life Sciences US . 1 day ago Be among the first 25 applicants. Get AI-powered advice on this job and more exclusive features. Job Summary The Contract Medical Writer applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications. Location San Rafael, California Job Type Contract Salary $68.00 - 70.94 per hour Work Hours 9 to 5 Education Bachelors Responsibilities Drafts and edits documents used for submissions including CTDs and RtQs Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, and informed consent forms Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PSURs, DSURs, etc.) Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes Adheres to departmental procedures and practices and technical and industry standards during all aspects of work Works effectively with cross-functional groups within the company Other tasks as assigned Qualifications At least 5 years' experience required Bachelor's or higher degree; scientific focus desirable Evidence of medical writing career development desirable, e.g., American or European certifications Strong expertise in developing and validating machine learning and AI techniques for image-like data Programming experience (Python/MATLAB/C/C++) Experience using high-performance compute clusters to train and deploy deep models Experience with statistics and data analysis/visualization of multi-dimensional data Familiar with the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for clinical studies Familiar with clinical study data collection and results reporting Previous protocol development experience required Experience writing, reviewing, or editing protocols and clinical study reports highly preferred Experience writing, reviewing, or editing INDs and BLA/NDAs highly preferred Intermediate to advanced knowledge of routine document content preparation, style guides, medical dictionaries, and guidance documents Intermediate to advanced knowledge of AMA, CBE, and Chicago Style Manuals Ability to interpret basic tabular and graphical clinical data presentations Ability to create basic tables using AMA style Basic understanding of coding dictionaries (MedDRA, WHO Drug) Basic understanding of biostatistical and clinical research concepts Experience with scanners, printers, and copiers Basic regulatory knowledge for clinical documents Skills: Editing, NDA, GCP, Medical Information, Medical Publications. We welcome all applicants and provide accommodations upon request. Pay depends on experience and qualifications. Benefits include medical, dental, vision, AD&D, life insurance, disability, and 401K. This posting is open for 30 days. Qualified applicants with criminal histories will be considered per local laws. #J-18808-Ljbffr Randstad Life Sciences US

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