• Independently author most study-level documents at simple to complex levels, for example: Protocol, protocol outlines, Subject Information/Informed Consent, Clinical study reports (CSRs), Lay summaries of clinical trial results, Investigator brochures (IBs). • Provide support to more experienced writers with the preparation of submission and other complex clinical documents. • Capable of interpreting and summarizing data. • Drive discussions, ensure decisions are taken and incorporate project strategies in documents. • Lead meetings and drive decisions concerning project/trial-specific medical writing issues. • Responsible for all medical writing aspects of task finalization including stakeholder alignment, coordination, and adherence to timelines.

• Leading the preparation, review, and editing of clinical study documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions, ensuring accuracy, clarity, and compliance with regulatory guidelines and industry standards. • Collaborating closely with cross-functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs, to interpret and analyze clinical trial data, summarize scientific findings, and communicate key insights in written form. • Participating in the planning and execution of clinical development programs, providing strategic input and scientific expertise to support the design, conduct, and interpretation of clinical studies and research initiatives. • Contributing to the development of publication plans, abstracts, posters, and manuscripts for submission to peer-reviewed journals and presentation at scientific conferences, disseminating study results and scientific insights to the broader scientific community. • Mentoring and coaching junior medical writers, providing guidance on best practices, writing techniques, and scientific principles, and fostering a culture of excellence, collaboration, and continuous learning within the medical writing team.

• Perform high-level, complex, secondary case reviews to facilitate and obtain appropriate provider documentation for clinical conditions or procedures • Ensure accuracy, completeness, and quality of clinical information used for measuring and reporting physician and hospital outcomes • Perform secondary case reviews to identify potential gaps or opportunities to facilitate improved provider documentation • Ensure clinical documentation accurately reflects the level of care rendered, severity of illness, risk of mortality, and clinical validation • Apply advanced knowledge of CMS star rating, Vizient, and US News and World Report risk-adjustment systems to identify clinical documentation improvement opportunities • Complete quality reviews focused on CDI quality elements, such as Mortality, Hospital Acquired Conditions (HAC), and other publicly reported patient quality or safety metrics • Identify trends and key areas for improvement in querying, coding, and documentation integrity • Demonstrate proficiency with ICD-10-CM/PCS, APR DRG, and MS DRG • Communicate and collaborate effectively with providers, HIM/coding, quality, CDI, and other members of the healthcare team

• Create accurate, high-quality scientific content for physicians, nurses, pharmacists, and other HCPs • Build PowerPoint decks, speaker notes, text modules, and supporting assets for: Webinars & virtual programs, Live programs & symposium highlights, Podcasts and multi-format education • Distill large source decks (e.g., 60–100 conference slides) into clear 10–15-slide educational stories with focused objectives and takeaways • Stay current on guidelines, pipelines, and key literature in assigned disease areas • Apply adult learning principles to content flow, interactivity, and reinforcement • Develop learning objectives, outlines, agendas, and assessment questions (polls, surveys, knowledge checks) • Translate complex data into accessible visuals; guide designers on chart selection and permissions-friendly approaches • Partner directly with faculty/KOLs: ask the right scientific questions, shape narratives, and uphold rigor • Align content with program goals and client expectations; diplomatically negotiate scope (e.g., realistic slide counts for allotted time) • Work cross-functionally with Medical Science Directors, producers, editors, and creative teams • Lead content work streams from kickoff through delivery across multiple concurrent projects • Manage evolving inputs (late-breaking data, faculty availability) and hit aggressive timelines • Maintain documentation, references, and version control across shared systems