• 医薬品開発における各種ドキュメントの作成・レビューを担当いただきます。 • 定期安全性報告書(DSUR関連文書)、治験実施計画書(Protocol)、同意説明文書( ICF)、治験総括報告書( CSR)などの作成 • 規制当局提出用文書のための資料作成 • プロジェクトリーダーとしての役割 • ジュニアメディカルライターのトレーニングとサポート

• Medical content with strategic impact – You don’t just produce well-founded texts; you develop targeted content that engages physicians, healthcare professionals and patients on complex medical topics as well as practical issues. • Game-changer instead of standard medical writing – You bring fresh ideas and think beyond traditional formats. Whether it’s interactive formats, storytelling or innovative digital knowledge transfer, you help elevate medical communication to the next level. • Development of new content strategies – You spot trends in healthcare communication, develop new content formats and implement innovative approaches to convey knowledge effectively. • Orchestration of medical communication channels – You create content tailored perfectly to different channels, from scientific whitepapers and social media to specialist publications.

Role Description Join Fairview as a Clinical Documentation Integrity Specialist and play a key role in ensuring accurate, complete, and compliant inpatient medical record documentation. In this fully remote position, you'll collaborate with physicians, coders, and clinical teams to: - Review patient records - Identify documentation improvement opportunities - Support accurate DRG assignment - Enhance quality outcomes, regulatory compliance, and reimbursement This role is ideal for an experienced RN, RHIA, or RHIT professional with a strong understanding of clinical documentation, coding, and inpatient care. You'll use your analytical skills and clinical expertise to drive documentation excellence while educating providers and contributing to continuous improvement initiatives. Qualifications - Associates Degree in Nursing or Health Information Management (HIM) degree or related field or equivalent experience - 2 years Acute/Inpatient experience as an RN or 5 years inpatient coding experience - Knowledge of clinical documentation requirements related to regulatory and reimbursement rules and regulations - Knowledge of current coding and DRG classification systems - Knowledge of medical terminology, anatomy and pathophysiology, pharmacology, ancillary test results - Knowledge of ICD-10-CM and DRG classification systems - Knowledge of physician and nursing unit practices - Excellent interpersonal, critical thinking and conflict management skills - Computer and data analysis skills - Excellent verbal and written communication and presentation skills - Analytical Thinking: Ability to identify issues, obtain relevant information, relate and compare data from different sources and identify alternative solutions - Attention to detail: Achieve thoroughness and accuracy when accomplishing a task - Critical Thinking: Gathers and integrates critical information, recognizing and addressing underlying assumptions of others to arrive at effective solutions - Medical Staff Relations: Builds effective partnerships with medical staff, physicians, fostering open lines of communications and establishing trust - Problem Solving: Identifies problems, determines accuracy and relevance of information, utilizes appropriate tools and staff resources along with sound judgment to generate and evaluate alternatives and to make recommendations - Written Communication: Ability to organize and express information and ideas in written form to individuals as well as groups. Constructs messages that are clear and convincing - Registered Nurse of MN Upon Hire or current Registered Health Information Administrator (RHIA) MN Board of Nursing or American Health Information Management Association Upon Hire or Registered Health Information Tech (RHIT) MN Board of Nursing or American Health Information Management Association Upon Hire Requirements - 5 years acute care nursing or 5 years inpatient coding experience (preferred) - Bachelors Degree in Nursing for candidates with nursing experience (preferred) - Certified Clinical Documentation Specialist (CCDS) for candidates with HIM experience American Health Information Management Association Upon Hire (preferred) Benefits - Generous benefit package including medical, dental, vision plans - Life insurance - Short-term and long-term disability insurance - PTO and Sick and Safe Time - Tuition reimbursement - Retirement - Early access to earned wages - And more! Company Description Fairview offers a collaborative, mission-driven healthcare environment with an opportunity to influence patient care quality and organizational outcomes.

• Oversee medical writing workstreams, ensuring deliverables meet quality and timeline expectations • Lead the preparation and review of clinical study reports, protocols, and other regulatory documents to ensure accuracy and clarity • Collaborate with cross-functional teams, including clinical research, biostatistics, and regulatory affairs, to gather and synthesize information for document development • Provide guidance on best practices for medical writing and ensure adherence to regulatory requirements and internal standards • Mentor and train junior medical writers, fostering a culture of excellence and professional growth • Stay current with industry trends and regulatory guidelines to inform writing practices and maintain high-quality outputs • Act as a lead medical writer for complex projects and lead clinical/regulatory marketing approval applications for new biologics and drugs