IQVIA logo
IQVIA

Accelerate innovation for a healthier world.

メディカルライター, FSO Medical Writer

Medical writerMedical writerFull TimeRemoteSeniorTeam 10,001+H1B SponsorCompany SiteLinkedIn

Location

Japan

Posted

81 days ago

Salary

0

Seniority

Senior

Bachelor DegreeJapaneseEnglishGoogle Cloud Platform

Job Description

メディカルライター, FSO Medical Writer

IQVIA

• 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

Job Requirements

  • 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
  • 臨床薬理の知識、経験がある方歓迎

Benefits

  • 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
  • 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

Related Categories

Related Job Pages

More Medical writer Jobs

IQVIA logo

Associate Medical Writer

IQVIA

Accelerate innovation for a healthier world.

Medical writer81 days ago
ContractRemoteTeam 10,001+H1B Sponsor

Role Description 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。 - 治験、PMS、臨床研究で作成される文書の編集、QCを行う。 - 社内SOPまたはクライアントのSOPを遵守して、決められた時間内に業務を行う。 - 必要に応じて経験者のサポートを受けて、適切なコミュニケーションを行う。 - メディカルライターが作成する文書の編集、QCを行うこと。 - 決められたタイムライン内で業務を行うこと。 - チームメンバーとして協力して高品質の文書作成に貢献すること。 Qualifications - 理系の大学卒であることが望ましい。 - 臨床試験関連文書(CSR、CTD)のQC経験があればなお可。 - 日本語文書の編集、QCの経験があれば可。 - 英語の文書を編集、QCした経験があればなお可。 Requirements - 臨床試験に関する基礎的な知識があること。 - Wordを用いた文書の整合性チェックができること。 - 文書内の用語の統一、解析結果の図表との整合性の確認ができること。 - PDF、Wordなどの文書の扱いに慣れていること。 - チームメンバーとして協力して成果をあげる協調性があること。 - 決められた時間内に業務を行うことができること。 Benefits - フルリモート・フルフレックス。 - 1年契約を想定し、毎年更新。 - ※状況に応じて変更になる可能性がございます。 Selection Process - 書類提出(履歴書・職務経歴書)。 - 書類選考。 - 筆記試験&人事面談(オンライン)※計2時間15分。 - 部門面接(オンライン)。 - 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。

Japan
Lumanity logo

Senior Medical Writer

Lumanity

Incisive Thinking, Decisive Action

Medical writer81 days ago
Full TimeRemoteTeam 1,001-5,000Since 2020H1B No Sponsor

Overview/About Lumanity Lumanity is dedicated to improving patient health by accelerating and optimizing access to medical advances. We partner with life sciences companies around the world to generate evidence to demonstrate the value of their product, translate the science and data into compelling product narratives, and enable commercial decisions that position these products for success in the market. We do this through strategic and complimentary areas of focus: Asset Optimization and Commercialization, Value Access and Outcomes, Medical Strategy and Communications, and Real-World Evidence. Responsibilities / Position overview We are seeking an advanced degree life-sciences professional to serve as a Senior Medical Writer within our Medical Strategy and Communications team, which serves our clients by mobilizing our scientific knowledge to interpret the data and create compelling narratives to guide their medical strategy and through regulatory challenges. The Senior Medical Writer will ensure high-quality content is developed for a wide range of medical communications projects and deliverables including clinical publications (manuscripts and abstracts), slide decks, scientific platforms, symposia, advisory boards, and training materials. In this role, the Senior Medical Writer has final sign-off authority and will review all deliverables on assigned accounts for technical accuracy, proper incorporation and interpretation of investigator/client data, and overall content and editorial quality. Experience supporting oncology publications accounts is highly desirable. Qualifications The ideal candidate will have an advanced degree in a life-sciences field, meticulous attention to detail and the ability to simultaneously work on multiple projects relating to multiple products in various therapeutic areas. Additional Requirements and Qualifications - PhD, PharmD, or MD - 2+ years' experience in a healthcare communications agency environment or similar - Outstanding writing, editing and communication skills and excellent command of the English language - Exceptional attention to detail in relation to both scientific content and editorial standards - Ability to adapt writing style to different materials and target audiences - High level of proficiency with Microsoft Office applications (particularly Word and PowerPoint) - Experience with referencing software and database searching desirable Benefits We offer our employees a comprehensive benefits package that focuses on what matters to you – health and well-being, personal finances, professional development, and a healthy work/life balance: - Competitive salary plus bonus scheme - Medical, dental, and vision insurance options - 401(k) plan with employer match - Generous amount of paid time off annually + 10 paid holidays - Employee Assistance Program - Company-paid short-term and long-term disability coverage - Flexible spending accounts for health and dependent care and much more ----------------------------------------------------------------------------- #LI-Remote #LI-Remote

United States
Cadence Health logo

Registered Nurse - APCM - IL license Required

Cadence Health

Cadence is committed to equal opportunity and fairness regardless of race, color, religion, sex, gender identity, sexual orientation, nation of origin, ancestry, age, physical or mental disability, country of citizenship, medical condition, marital or domestic partner status, family status, family care status, military or veteran status or any other basis protected by local, state or federal laws. A notice to Cadence applicants: Our Talent team only directs candidates to apply through our official careers page at https://www.cadence.care/our-team . Cadence will never refer you to external websites, ask for payment or personal information, or conduct interviews via messaging apps. We receive all applications through our website and anyone suggesting otherwise is not with Cadence. If you require a reasonable accommodation during the hiring process, please contact people@cadencerpm.com .

Medical writer81 days ago
Full TimeRemoteTeam 201-500

In the U.S., 60% of adults – more than 133 million people – live with at least one chronic condition. These patients need frequent, proactive support to stay healthy, yet our care system isn’t built for that level of attention. With rising clinician shortages, strained infrastructure, and reactive care models, patients too often end up in the ER or the hospital when those outcomes could have been prevented. At Cadence, we’re building a better system. Our mission is to deliver proactive care to one million seniors by 2030. Our technology and clinical care team extend the reach of primary care providers and support patients every day at home. In partnership with leading health systems, Cadence consistently monitors tens of thousands of patients to improve outcomes, reduce costs, and help patients live longer, healthier lives. *]:pointer-events-auto scroll-mt-[calc(var(--header-height)+min(200px,max(70px,20svh)))]" data-turn-id="request-6973a1b9-fbd8-8325-be36-66622ef94b91-13" data-testid="conversation-turn-40" data-scroll-anchor="true" data-turn="assistant"> Cadence Health is seeking a Care Management Registered Nurse to support patients enrolled in our Advanced Primary Care Management (APCM) program. In this role, you will proactively monitor patient data, evaluate clinical information, and deliver timely interventions to promote patient safety and improved health outcomes. You will work closely with interdisciplinary care teams to reinforce care plans, support medication adherence, close care gaps, and provide patient education that empowers individuals to actively manage their health and chronic conditions. Licensure Requirements - Active Compact Multi-State RN license is required - An active Illinois RN License Schedule Requirements: - This role requires availability Monday - Friday. - Schedule hours are 9:00 AM to 6:00 PM Central Time What you'll do: - Proactively monitor patient vitals, symptoms, and relevant clinical data to identify care gaps and patients who require timely intervention. - Develop, implement, and manage individualized care plans aligned with physician recommendations and patient-specific health goals. - Engage with patients via phone and secure messaging to address concerns, manage escalations, and provide empathetic, responsive clinical support. - Conduct virtual follow-up visits to support program onboarding, adjust care plans, reinforce medication adherence, and help patients progress toward lifestyle and health goals. - Document all clinical interactions accurately and efficiently, and prepare clear care summaries for patients’ primary care providers to ensure seamless coordination. - Partner with interdisciplinary care teams to deliver high-quality, patient-centered care across chronic conditions such as CHF, hypertension, and type 2 diabetes. - Contribute to the development and refinement of clinical workflows and processes to support efficient, scalable, and high-impact care management programs. - Represent Cadence’s commitment to exceptional care in every patient interaction, aligning with the standards and goals of our health system partners. What you'll need: - Multi-state RN Compact State Licensure. - Active Illinois state RN license. - Associate Degree in Nursing Science. - 5+ years of recent clinical experience as an RN in an ICU/ER setting is preferred. - Prior experience supporting patients in a chronic care management program is a plus. - To ensure that our clinicians have the necessary tools for a successful remote work environment, home office setups must have consistently stable wifi with strong upload and download speeds. A wifi speed test is required before participating in the interview process to verify that these standards are met. - Skilled in nursing processes. - Excellent clinical acumen. - Exceptional written, verbal, and interpersonal communication skills. - EMR experience, preferably in Athena and EPIC. - Works effectively with minimum supervision. - Strong collaboration with cross-functional partners. - Ability to support the delivery of health care to patients by performing a variety of activities and procedures that are prescribed by and performed under the direction of the Cadence Nurse Practitioner and Cadence clinical policies and procedures. - Patient assessment competency. - Technical fluency with the ability to work in multiple platforms and systems, including Notion, Athena, EPIC, Zendesk, and G Suite. The anticipated base salary range for this role is $80,000 to $90,000 annual base salary, which is based on role scope, level, and location. In addition to base compensation, this role may be eligible for incentive compensation as part of the overall total rewards package. This position is remote and based in the United States. Actual compensation will be determined based on factors including experience, skills, internal equity, and applicable law. Who we are Cadence Health was built around a simple promise: patients always come first. Our technology-enabled remote care model pairs continuous health insights with a highly skilled clinical Care Team, empowering seniors to stay healthier, avoid complications, and live more independent, fulfilling lives, all without the limits of a traditional office visit. Your expertise is the heart of our system. Nurse practitioners, registered nurses, medical assistants, patient-success coordinators, and other frontline clinicians are the face and beating heart of Cadence. You’ll bring warmth, clinical precision, and the empathy that turns a virtual touchpoint into a human connection. Every chat, phone call, and care plan you deliver shapes how patients experience “what healthcare should be.” A modern toolkit to practice top-of-license care We’ve replaced reactive visits with real-time data, intelligent workflows, and seamless collaboration tools. That means you can spend less time on busywork and more time practicing at the top of your license, coaching patients, spotting risks early, and coordinating with physicians to keep care proactive and personal. Thriving in a fast-moving, mission-driven culture. Change excites us. Innovation fuels us. If you’re energized by technology, eager to re-imagine care delivery, and motivated to improve outcomes for both patients and the providers who serve them, you’ll feel at home here. We invest in continuous learning, clinical mentorship, and transparent growth paths so you can advance your skills while making a measurable impact every day. Join us in redefining healthy aging. If you’re passionate about compassionate care and ready to transform how seniors across the country manage chronic conditions, recover after hospitalization, and age with confidence, let’s talk. Together, we’ll build a future where exceptional care is consistent, connected, and just a call away. What You'll Get: Cadence full-time employees are eligible for the benefits described below. Part-time employees may qualify for benefits mandated by state or local law. Cadence recognizes the unique needs of its diverse, distributed workforce and seeks to provide an inclusive work environment for its world-class clinicians and technologists. - Company culture all about impact, shared growth mindset, empowerment, and integrity - An opportunity to help improve the quality of life of millions of Americans - Unique chance to support the development of an amazing product; Cadence’s in-house clinicians are our super users and beta testers - Competitive salaries and quarterly incentives - Medical, dental, and vision insurance - Competitive PTO - 401K and 401K match - National and local discounts powered by TriNet - Onboarding stipend for remote equipment and home office setup - Paid Parental Leave - Charitable Donation Match program We are committed to equal opportunity and fairness regardless of race, color, religion, sex, gender identity, sexual orientation, nation of origin, ancestry, age, physical or mental disability, country of citizenship, medical condition, marital or domestic partner status, family status, family care status, military or veteran status or any other basis protected by local, state or federal laws. Candidates must be willing to comply with all pre-employment drug screening requirements and, where applicable, comply with additional drug screening requirements as a condition of continued employment in accordance with company policy and applicable law. *A notice to Cadence applicants: Our Talent team only directs candidates to apply through our official careers page at https://www.cadence.care/our-team. Cadence will never refer you to external websites, ask for payment or personal information, or conduct interviews via messaging apps. We receive all applications through our website and anyone suggesting otherwise is not with Cadence.

United States
$80K - $90K / year
Job Closed
Trinity Health logo

Clinical Documentation Specialist

Trinity Health

We are one of the largest not-for-profit, faith-based health care systems in the nation.

Medical writer81 days ago
Full TimeRemoteTeam 10,001+H1B Sponsor

• Clinical Documentation Specialist utilizes advanced clinical and coding expertise to direct efforts toward the integrity of clinical documentation through the roles of reviewer, educator and consultant. • Facilitates the overall quality, completeness, accuracy, and integrity of medical record documentation through extensive record review. • Conducts concurrent reviews of selected patient records to address legibility, clarity, completeness, consistency, and precision of clinical documentation. • Demonstrates understanding of clinical documentation requirements to ensure that the severity of illness, risk of mortality, and services provided are accurately reflected in the record. • Communicates documentation discrepancies and coding definitions to the physicians both written and verbally as needed to clarify clinical documentation in accordance to query standards and/or policies. • Conduct 1:1 educational sessions with physicians and other healthcare team members related to specific documentation requirements. • Collaborates with the multi-disciplinary team, including physicians, patient care services, case management, coding specialists and other healthcare disciplines regarding clinical documentation issues.

Ohio
$36 - $56 / hour
Job Closed