• Works with team members and with MW lead oversight to create the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. • Ensures adherence to internal standards and procedures • Maintains document standardization via model documents/templates and appropriate peer review • Remains current with writing guidelines and industry standards, participates in educational opportunities

• Responsible for improving the overall quality and completeness of clinical documentation in the medical record to reflect the severity of illness, clinical treatment, decisions and diagnoses of patients. • Involves concurrent medical record review, DRG validation, querying providers, capture of clinical and quality indicators to ensure the thoroughness of documentation prior to coding and billing. • Responsible for the day-to-day review and evaluation of clinical documentation by the Medical Staff and healthcare team in accordance with the network's designated clinical documentation policies and procedures. • Calculates working DRG within CDI tracking systems/software. • Performs follow-up on cases through patient discharge. • Applies clinical knowledge and experience to the daily review and evaluation of the medical record including physician/clinical documentation, lab results, diagnostic information and treatment plans. • Promotes integrity of clinical documentation and thoroughness of the medical record to ensure appropriate severity of illness, risk of mortality, length of stay and reimbursement are captured. • Communicates with providers via verbal and/or electronic clinical documentation integrity queries to clarify missing, unclear or conflicting medical record documentation; identifies opportunities for service line and individual provider education and communicates to CDI leadership. • Achieves key performance indicators in the areas of productivity/thoroughness and quality.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities: Note: The below statements describe the general nature and level of the work being performed and are not an exhaustive list of all responsibilities required for the position. Responsibilities vary as applicable Accountability Supporting Activities Aggregate reports  Preparing/updating/merging RMPs/Company Core-RMPs (CC-RMPs), preparing a health authority response document along with RMS update in accordance with client requirements/conventions and SOPs.  Managing scheduled and unscheduled aggregate reports including but not limited Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United States Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Annual Risk- Benefit Evaluation (ARBE) report Safety statements, Health Hazard Evaluation (HHE), Drug Safety Report (DSR), Clinical Overview (CO), Safety Evaluation Report (SER), Investigational New Drug Annual Report (INDARs), comparison document between local and global labeling document (if applicable)and checking of International Non-proprietary names (INNs) for inclusion in a PSR as per client requirements and conventions and SOPs  Conducting critical appraisal and systematic review of literature with a focus on background epidemiology, specifically information on the incidence, prevalence and risk factor in patient populations, for inclusion in drug Safety Reports and RMPs  Providing input and developing literature search strategies for the epidemiology section of safety reports  Applying epidemiological methods and calculations to data available in literature to support the background rates of the issues under evaluation for the safety reports  Generating Line Listings for submissions/ to identifying discrepancies and ensuring resolution of the discrepancies  Revising document drafts based on the review comments from team members to ensure inclusion of all relevant input.  Ensuring that all work is complete and of high quality prior to team or client distribution. Confirm data consistency and integrity across the document.  Performing aggregate report compliance activities including quality review to check the data/facts and internal consistency across various type of aggregate reports including but not limited to PBRERs, Ad hocs, HHEs, LJDs, tables, RMP, Pharmacovigilance System Master File (PSMF) document (as applicable)  Distributing of final reports to the stakeholders including partners, affiliates and submission to health authorities, according to the agreed timelines, distribution lists and email templates (as required) Job Description TP-HR-WW-001-11 TP-BPM-WW-032-05 TP Effective Date: 18 May 20 Related to: SOP-BPM-WW-001 TP Related to: SOP-HR-WW-001 JD Version date: 01-Jul-2020 Page 3 of 4  Scheduling and coordinating meetings/ Drafting meeting agenda and minutes/Tracking action items and soliciting follow-up for open issues Clinical Study Report Narratives  Coordinates and liaises with the members of Study Management Team (SMT)/Study In-charge or equivalent, to discuss the narrative template development process, narrative categories and review of the narratives (as required)  Serves as primary client contact for narrative writing for an assigned study, agreeing/negotiating deliverable timelines, and addressing/resolving any narratives related issues (as required)  Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs provided by the client and ensures their appropriate medical cohesiveness and assessment in accordance with the client’s and Parexel’s conventions/guidelines and Standard Operating Procedures  Performs quality checks on the drafted narratives as required  Ensures the work is complete and of high quality, including final quality control checks, compilation and formatting.  Provides CSR narrative review support to the SMT where requested Signal Detection and Management  Perform signal detection review and analysis (qualitative and quantitative) from various sources e.g. regulatory authority database, client database, literatures, regulatory authority websites etc.  Responsible for the end-to-end signal management process (i.e. signal tracking, signal assessment/data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO  Conduct/support signal detection and evaluation activities according to SOPs and guidelines General  Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, procedures and SOPs, and international drug safety regulations  Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for the adverse event reporting  Maintaining a good working knowledge of the assigned Clinical studies for narratives  Ensuring that all work is complete and of high-quality  Attending/conducting internal, drug safety and project specific training sessions  Preparation for, participation in, and follow up on audits and inspections  Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits  Delegating work as appropriate to Associate Medical Writer and Medical Writer I  Striving to enhance client’s satisfaction based on feedback provided by the client  Imparting project specific trainings to the new starts as required.  Serving as the primary client contact, liaising and collaborating with the relevant function at the client’s end to facilitate the delivery of high-quality work  Evaluating and incorporating reviewer comments in draft reports and liaising with relevant contributors for resolution of comments Job Description TP-HR-WW-001-11 TP-BPM-WW-032-05 TP Effective Date: 18 May 20 Related to: SOP-BPM-WW-001 TP Related to: SOP-HR-WW-001 JD Version date: 01-Jul-2020 Page 4 of 4  Mentoring new recruits in the team, if required  Archiving the source documents and relevant emails as required  Responding to clients/customers in a timely manner  Participating in departmental or interdepartmental process improvement and training initiatives (if required) Skills:  Analytical and problem-solving skills  Excellent interpersonal skills  Excellent verbal / written communication skills  Excellent organizational and prioritization skills  Ability to work collaboratively and effectively in a team environment  Client focused approach to work  Ability to evaluate data and draw conclusions independently  A flexible attitude with respect to work assignments and new learning  Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail  Ability to understand all necessary steps in a project, plan steps ahead, and identify critical paths.  Fluency in written and spoken English  Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)  Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text  Typing and transcription accuracy  Awareness of global culture and willingness to work in a matrix environment Knowledge and Experience:  Relevant experience is desirable in Regulatory/ Pharmacovigilance or related field.  Good knowledge of medical terminologies Education:  Science/Medicine degree: The minimum qualification required would be a university degree in life Sciences/ Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.)  A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage

【会社紹介・ビジョン】 私たちIQVIAは、ヒューマンデータサイエンスの先駆的な企業として、医療・ヘルスケアの前進に取り組む皆様をIQVIAならではの革新的なソリューションによってご支援することで、「誰もが、より健康に自分らしく生きられる社会」の実現を目指しています。世界最大規模を誇る医療・ヘルスケア関連データを基盤に、人・データ・サイエンスを融合させた見地から、未だ満たされない治療ニーズに応える、新たな医薬品や医療機器の開発と市販化、厳格化する規制やコンプライアンスへの対応、持続可能な医療システム推進の支援など、患者さんをはじめとするすべての人々のために、より良い未来へと医療・ヘルスケアを前進させていく力となることが、私たちの使命です。 世界100以上の国と地域で約9万人が活動するIQVIAの日本法人として、IQVIAジャパンでは約6,000人が一丸となり、この使命に向かって日々、力を尽くしています。 【部署・チーム名】 Medical Writing部門では、国内外の製薬会社・ベンチャー企業等から、幅広い治療分野の業務を受託しているため、様々な文書作成に携わり、非常に多くの経験をすることができます。また、社内の教育システムも充実しており、新規案件に対して専門的なアプローチが可能な体制になっています。 【主な業務内容】 メディカルライター（担当者）として次のような業務をお任せします。 - 臨床試験関連文書（治験実施計画書、治験総括報告書、コモンテクニカルドキュメント等）の作成 - グローバル試験の治験実施計画書に対して日本要件を満たすための修正版の作成 - 製造販売後調査関連文書（安全性定期報告、再審査申請資料等）の作成 - 臨床研究報告書・論文の作成 - 各種文書のQC　他 【求める人物像】 必須条件 - Medical Writing実務経験がある（翻訳のみの方は対象外） - 理系大学、大学院卒 - 薬学･医学的な基礎知識を有する - 医薬品開発全般、GCP、ICH関連ガイドライン、国内薬事規制(GPSP等)を理解している - 英語の読み書きが可能（辞書を使って英文書の添削や和文英訳が可能なレベル） - Fluency in Japanese would be required 歓迎要件 - 臨床薬理の知識、経験がある方 【このポジションの魅力・キャリアパス・チーム構成・雰囲気】 - 医薬品、医療機器、再生医療等幅広い分野の開発品目に関する文書作成を経験できます - 文書作成に際し、社内の医師や薬事の専門知識を有する者からアドバイスを受けることできます - グローバルメディカルライティングのメンバーとしてグローバルな環境で仕事をすることができます 【勤務地】 全国フルリモート可 【雇用形態・勤務時間・福利厚生・休日休暇】 - 雇用形態：正社員／契約社員 - 勤務時間：9:00-17:30 - フレックス勤務：あり - 在宅勤務制度：あり 福利厚生：法定内（社会保険制度）・法定外（IQVIA独自制度）の両面から充実した福利厚生制度あり - 受動喫煙対策：あり - 休日休暇：年次有給休暇、夏季休暇、病気休暇、特別休暇、女性特別休暇、育児介護休暇、看護休暇·など - 試用期間：あり（通常６か月） 【給与・待遇】 - 給与：当社規定により優遇します - 昇給：あり - 賞与：あり - 時間外手当：あり 【選考プロセス（オンライン完結）】 ①書類提出（履歴書・職務経歴書） ②書類選考 ③筆記試験&人事面談（オンライン）※計2時間15分 ④部門面接（オンライン） ◆補足◆ 部門面接について - 部門マネジャー　30分の個別面接 - 部門ディレクター　1時間の個別面接 同日に1時間30分続けて実施 ※難しい場合は別日に分けて調整が可能です。 IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.