Role Description - Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias. - Write and edit clinical development documents, including but not limited to, Informed Consent Forms and Clinical Protocols. - Complete writing assignments in a timely manner. - Maintain timelines and workflow of writing assignments. - Practice good internal and external customer service. - Highly proficient with styles of writing for various regulatory documents. - Expert proficiency with client templates & style guides. - Interact directly and independently with client to coordinate all facets of projects; competent communication skills for projects. - Contribute substantially to, or manages, production of interpretive guides. - Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary. - Mentor medical writers and other members of the project team who are involved in the writing process. Qualifications - At least 3 years of previous experience in the pharmaceutical industry. - Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience. - The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline. - Oncology, General Medicines, Infectious Diseases and Vaccine experience preferred. - Substantial informed consent and clinical study protocol experience, as lead author, required. - Experience leading and managing teams while authoring regulatory documents with aggressive timelines. - Experienced in understanding complex clinical information. - Translate complex medical and scientific information into clear, patient-friendly language. - Experienced in collaboration and cross-functional communication. - Exceptional writing skills are a must. - Excellent organizational skills and the ability to multi-task are essential prerequisites. - Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools. - Experience being a project lead, or managing a project team. - Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus. - Not required, but experience with orphan drug designations and PSP/PIPs a plus.

Overview The ROI Specialist is responsible for providing support at a specified client site for the Release of Information (ROI) requests for patient medical record requests* Responsibilities - Determines records to be released by reviewing requestor information in accordance with HIPAA guidelines and obtaining pertinent patient data from various sources, including electronic, off-site, or physical records that match patient request. - Answer phone calls concerning various ROI issues. - If necessary, responds to walk-in customers requesting medical records and logs information provided by customer into ROI On-Line database. - If necessary, responds and processes requests from physician offices on a priority basis and faxes information to the physician office. - Logs medical record requests into ROI On-Line database. - Scans medical records into ROI On-Line database. - Complies with site facility policies and regulations. - At specified sites, responsible for handling and recording cash payments for requests. - Other duties as assigned. Qualifications - Demonstrates proficiency using computer applications. One or more years experience entering data into computer systems. Experience using the internet is required. - Demonstrates the ability to work independently and meet production goals established by MRO. - Strong verbal communication skills; demonstrated success responding to customer inquiries. - Demonstrates success working in an environment that requires attention to detail. - Proven track record of dependability. - High School Diploma/GED required. - Prior work experience in Release of Information in a physician’s office or HIM Department is a plus.Knowledge of medical terminology is a plus. - Knowledge of HIPAA regulations is preferred.

• Responsible for concurrent review of inpatient medical records to identify opportunities for improving the quality of medical record documentation. • Identify cases where diagnoses and procedures are either absent, not stated in appropriate terminology, or not appropriately recorded. • Confer with the appropriate caregiver on the additional documentation that may be required. • Achieve a complete medical record by the time of patient discharge to ensure quality documentation that reflects the patients' diagnoses, treatments, and severity of illness. • Facilitate and enhance the coding and DRG assignment process. • Support initiatives to improve the quality of documentation by all caregivers within the Ohio State University Health System.

• Production of scientific content • Update of existing content • Adjust content according to feedback received during review cycles • Obtain final approval from relevant stakeholders • Perform peer reviews for style and accuracy and for continuous improvement purposes