Senior Medical Writer
Location
Japan
Posted
52 days ago
Salary
0
Seniority
Senior
No structured requirement data.
Job Description
Senior Medical Writer
ICON plc
Role Description We are currently seeking a Senior Medical Writer to join our diverse and dynamic team. As a Senior Medical Writer at ICON, you will play a pivotal role in leading the development and execution of medical writing strategies for clinical research projects, contributing to the advancement of innovative treatments and therapies. - 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. Qualifications - Advanced degree in Life Sciences, Pharmacy, Medicine, or related field, with a minimum of 3-5 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry. - Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses, with excellent writing, editing, and proofreading skills, and the ability to communicate scientific concepts to diverse audiences. - Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications, and experience in interacting with regulatory agencies during the review and approval process. - Demonstrated ability to work effectively in a fast-paced, deadline-driven environment, managing multiple projects simultaneously and prioritizing tasks based on project timelines and deliverables. - Excellent interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams, build relationships with key stakeholders, and influence decision-making processes. - 大学卒以上(医薬、獣医、農学、生命科学等の学部学科)、または同等の学位保有者。 - 製薬会社、またはCROにおける5年以上のメディカルライティング業務の経験。 - 主要な当局提出資料の作成にメディカルライターとして関与した経験。 - プロトコール設計から承認申請までのプロセスや、技術的問題を含む臨床開発に関する十分な知識。 - 規制要件、ICHガイドライン、文書作成(CTDを含む)に関する薬事的プロセスについての知識。 - ビジネスレベルの英語力(読み書きスピーキングについて業務遂行プロジェクトリードに支障がないこと)。 Requirements - Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Benefits - Competitive base salary and performance related incentives. - Health and wellbeing programmes including medical, dental, and vision coverage where applicable. - Retirement and pension plans. - Life assurance and disability coverage. - Employee assistance programmes and wellbeing resources. - Learning and development opportunities through structured training and career pathways. - Benefits may vary depending on role and location. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request.
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Role Description The CDI Specialist facilitates and obtains appropriate physician documentation for any patient clinical condition or procedure to support the appropriate severity of illness, expected risk of mortality, and complexity of care as documented in patient medical records. Extensive medical record review and interaction with physicians, nursing staff, other patient care givers and HIM coding professionals is done to ensure the documentation is complete and accurate. - Completes initial patient medical record review within 24-48 hours of patient's admission; completes subsequent reviews of patient's medical record reviews every 24-48 hours and enters review findings in CDE software system. - Assigns Principal diagnosis, CC/MCC (complication and comorbidity/major complication and comorbidity), evaluates for Severity of Illness (SOI) and Risk of Mortality (ROM) on all patients while in-house. Assigns working ICD-10-CM and PCS codes and DRG (Diagnosis Related Group) using encoder in CDE software. - Clarifies with physicians regarding missing, unclear, unsupported or conflicting health record documentation by requesting and obtaining additional documentation from physicians when needed. Face to face physician interaction and written clarifications are used. - Educates key healthcare providers such as physicians, nurse practitioners, allied health professionals, nursing and care coordination regarding clinical documentation improvement, documentation guidelines and the need for accurate and complete documentation in the health record. - Partners with coding professionals to ensure accuracy of diagnostic and procedural data and completeness of supporting documentation to determine the working and final DRG assignment. Reviews DRG denial letters and writes denial appeal letters. - Collaborates with care coordination, nursing staff and other ancillary staff regarding interaction with physicians on documentation and to resolve physician clarifications prior to patient discharge. - Maintains and upholds all clinical documentation regulatory guidelines. - Formulates and submits timely, well prepared appeals for reconsideration by third party administrators (payors). Including supporting documented clinical evidence, Coding/CDE Guidelines and other regulatory standards/guidelines as appropriate. Works collaboratively with co-workers and management to effectively resolve root cause issues that impact payor contracts, hospital operations, or departmental to maintain reimbursement and minimize appeal requests and/or denials. Qualifications - Minimum of five years acute care nursing experience with specific medical/surgical, Intensive Care, or Emergency Department experience. - Excellent interpersonal skills including excellent verbal and written communication skills; proficient in and demonstrate excellent physician relations. - Ability to organize and present information clearly and concisely; excellent computer and keyboarding skills; high degree of prioritization skills. - Must be inquisitive and demonstrate openness to innovation including AI to explore better processes and ways to alleviate friction and improve patient and client experiences. Requirements - Current RN Licensure. - CRCR Required within 9 months of hire. Benefits - Bonus Incentives. - Paid Certifications. - Tuition Reimbursement. - Comprehensive Benefits. - Career Advancement.
Co-Founder & CEO – HealthTech, AI Clinical Documentation Compliance
FutureSightWe build world-class software companies with values driven founders.
• Set the venture's direction and lead its execution • Refine the ICP, pricing model, and product positioning • Lead pilots with compliance and revenue cycle leaders, convert them to paid engagements, and build the go-to-market motion • Partner with the FutureSight product and engineering team to ship V1 and iterate on user feedback • Lead the seed raise, supported by FutureSight's network and traction • Recruit and lead the founding team, and establish the cultural foundation of the company
Co-Founder & CEO – HealthTech, AI Clinical Documentation Compliance
FutureSightWe build world-class software companies with values driven founders.
• Set the venture's direction and lead its execution. • Refine the ICP, pricing model, and product positioning • Lead pilots with compliance and revenue cycle leaders, convert them to paid engagements, and build the go-to-market motion • Partner with the FutureSight product and engineering team to ship V1 and iterate on user feedback • Lead the seed raise, supported by FutureSight's network and traction • Recruit and lead the founding team, and establish the cultural foundation of the company
Co-Founder & CEO – HealthTech, AI Clinical Documentation Compliance
FutureSightWe build world-class software companies with values driven founders.
• Set the venture's direction and lead its execution • Refine the ICP, pricing model, and product positioning • Lead pilots with compliance and revenue cycle leaders, convert them to paid engagements, and build the go-to-market motion • Partner with the FutureSight product and engineering team to ship V1 and iterate on user feedback • Lead the seed raise, supported by FutureSight's network and traction • Recruit and lead the founding team, and establish the cultural foundation of the company

