Job Description

The University of Miami/UHealth Department of SCCC - Protocol Development Office (PDO) has an exciting opportunity for a Full Time Scientific Writer (Medical Writer) to work Remotely. The Scientific Writer analyzes scientific data and translates complex scientific concepts, written or oral, within a variety of fields into prose appropriate to the level of understanding of the target audience. This job also assists the Principal Investigator (PI) with the development and/or completion of scientific documents, which include the creation, formatting, proofreading, editing and finalization of scientific documents. Core job functions include creating and maintaining competitive application templates for grant proposals, formatting, substantive copy and scientific editing, proofreading, and finalizing documents, ensuring readability, clarity, consistency, and conformance to submission requirements, reviewing document language for scientific/medical accuracy, communicating with PIs and senior leadership authors, editing extramurally funded proposals, developing scientific presentations, ensuring regulatory compliance, managing copyright and conflict of interest documentation, tracking publication progress, and adhering to university policies. The Scientific Writer supports investigator-initiated trials (IITs) at the Protocol Development Office, collaborating with PIs and clinical research teams to write study-related documents including clinical trial protocols and informed consent forms. The role involves managing clinical trial lifecycles including protocol and ICF development, institutional regulatory submissions (PRMC and IRB), FDA IND submissions, and amendments. Responsibilities include writing, reviewing, formatting, proofreading, editing, and finalizing clinical research deliverables, collaborating with project stakeholders, managing regulatory submissions, preparing FDA IND submissions, coordinating meetings, managing deadlines, maintaining communication with clinical teams, performing peer reviews, advising on medical writing issues, and other assigned duties. Qualifications include a minimum bachelor's degree in biomedical sciences or related discipline (master's preferred), minimum 3 years relevant experience, preferably in medical writing, oncology, and medical research, strong communication skills, attention to detail, ability to multitask and meet deadlines, critical thinking, CITI certification within first month, knowledge of regulatory requirements, and proficiency in MS Word, PowerPoint, Outlook, and Adobe Acrobat Pro. The University of Miami offers competitive salaries and comprehensive benefits including medical, dental, and tuition remission. The position is full-time and remote.

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