• Lead the compilation, writing, and editing of high-quality clinical study synopses, minutes of advisory boards and study steering committees, and clinical sections of regulatory documents • Interpret data, search and analyze published literature, define problems, establish facts, draw valid scientific conclusions, propose solutions or corrective actions and compose text accordingly. • Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed. • Maintain working knowledge of the Telix clinical development pipeline. • Prepare, review, and edit clinical documents including, but not limited to, clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), informed consent forms (ICFs), and regulatory submission documents (e.g., INDs, NDAs, BLAs, CTDs). • Ensure all documents comply with regulatory guidelines, company standards, and industry best practices. • Lead and manage multiple medical writing projects simultaneously, ensuring timely delivery of high-quality documents. • Coordinate with cross-functional teams to gather necessary information and resolve any issues that arise during the document development process. • Conduct thorough reviews of documents for accuracy, consistency, and clarity as needed. • Work closely with clinical development teams, including clinical operations, regulatory affairs, biostatistics, physicians, and medical affairs, to ensure alignment and accuracy of clinical documents. • Provide medical writing expertise and support to project teams, contributing to strategic planning and decision-making. • Mentor and train junior medical writers, providing guidance and support to enhance their skills and career development, along with oversight to external contractors. • Stay current with industry trends, guidelines, and best practices, and share knowledge with the team. • Support regulatory submissions by preparing high-quality documentation and addressing health authority comments and queries. • Ensure compliance with regulatory requirements and timelines for all submission-related activities.

• Comprehensively review outpatient provider notes for accuracy and completeness. • Synthesize coding correction opportunities for ongoing provider education. • Achieve 90%+ audit results on coding correction accuracy and less than 25% on missed coding correction opportunities. • Review on average a minimum of 20 provider notes per day. • Maintain and grow the current knowledge of the Medicare and Commercial Risk Adjustment outpatient/inpatient billing systems/processes • Identify trends and training opportunities to support clinical documentation accuracy improvement. • Champion Coding Corrections standards and drive integration into Canopy tools and ongoing Care Team processes • Other duties as assigned.

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.