Medical Writer II
Location
Japan
Posted
3 days ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
Medical Writer II
Parexel
Role Description The Medical Writer (MW) will research, create, and edit all documents associated with clinical research. Responsibilities also include: - Acting as primary client contact for medical writing projects. - Working with other Parexel departments and clients to set and meet internal/external deliverable timelines. - Project leadership and training and support of junior medical writing staff. Key Accountabilities: - Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: - Briefing documents - Investigator brochures - Study protocols - Model informed consents - Interim and final clinical study reports - Common technical document (CTD) clinical overviews and summaries - Safety update/aggregate reports - Integrated summaries of safety and efficacy - Ensure that all work is complete and of high quality prior to team distribution or shipment to the client, including: - Data consistency and integrity - Publishing readiness - Adherence to regulatory guidelines - Compliance with departmental, corporate or client SOPs - Act as project manager/lead for medical writing projects, which may entail: - Serving as the primary client contact - Negotiating deliverable timelines - Resolving project-related issues - Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership, including: - Communicating content requirements - Coordinating and conducting interdepartmental team review of draft and final documents - Scheduling and leading/facilitating authoring team meetings - Evaluating progress on tasks and identifying issues - Managing/Driving the timeline and advancing document development to approval - Distributing final documents to project team and client Qualifications - Excellent interpersonal, verbal, and written communication skills. - Ability to consistently produce documents of high quality. - Demonstrates attention to details and proactivity. - Ability to understand all necessary steps in a project, plan ahead, and identify critical paths. - A flexible attitude with respect to work assignments and new learning; readily adapts to changes. - Ability to efficiently manage time spent on tasks and proactively identify deficiencies. - Competent working in a matrix environment and values the importance of teamwork. - Ability to negotiate on behalf of medical writing to ensure resources, timelines, and expectations are aligned. - Understands and satisfies client needs. - Gains trust and establishes a connection with the client beyond one's project. - Provides departmental expertise and perspectives to promote prospective business opportunities. Requirements - Japanese periodic safety report (especially DSUR annex format and unknown non-serious adverse event report) creation experience of 1 year or more. - Medical writing experience of 3 years or more. - Business-level English proficiency. Benefits - Ability to leverage English skills in a global environment. - Opportunity to enhance expertise in the area of safety reports. - Contribute to regulatory submissions through the creation of important documents in drug development. - Flexible working environment.
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• Prepare copy for a broad range of medical communication projects that meet company standards related to grammar, scientific accuracy and client objectives. These deliverables will include abstracts, scientific posters, manuscripts, slide decks, medical affairs deliverables and more. • Be proactive in ensuring delivery of assigned work within budget and according to promised deadlines • Liaise confidently and appropriately with clients and external thought leaders to ensure smooth running of assigned projects • Interpret and incorporate internal and external review comments ensuring consistency, scientific accuracy and industry compliance • Ensure all relevant information is shared with both editorial and client services team members • Maintain (or attain) awareness of therapeutic area, competitors, new products and new indications for relevant accounts • Assist the client services team by proactively discussing any changes in project specification/deadline that impact on project budgets and financial forecasts • Record and monitor actual versus budgeted time on own projects, complete timesheets accurately and submit on time to line manager, relevant client services lead(s) and finance department weekly • Keep abreast of industry self-regulation and compliance guidelines as well as client SOPs, and maintain good working practices at all times
Role Description Our Medical Writers work closely with members of the scientific team to develop high-quality medical communications materials across a range of formats, including: - Abstracts - Posters - Manuscripts - Slide decks - Presentations They focus on producing scientifically accurate, well-written content that meets client objectives, internal quality standards, and industry compliance requirements. This position offers hands-on exposure to medical communications writing while building strong foundations in scientific storytelling, accuracy, and editorial best practice. Alongside writing, our Medical Writers support project delivery by: - Managing their own tasks and deadlines - Contributing to research across therapeutic areas - Incorporating review feedback effectively - Developing knowledge of disease areas, competitors, and emerging data - Accurately tracking time against project budgets As a Medical Writer with Prime, you will: - Prepare copy for a broad range of medical communication projects that meet company standards related to grammar, scientific accuracy, and client objectives. - Be proactive in ensuring delivery of assigned work within budget and according to promised deadlines. - Liaise confidently and appropriately with clients and external thought leaders to ensure smooth running of assigned projects. - Interpret and incorporate internal and external review comments ensuring consistency, scientific accuracy, and industry compliance. - Ensure all relevant information is shared with both editorial and client services team members. - Maintain (or attain) awareness of therapeutic area, competitors, new products, and new indications for relevant accounts. - Assist the client services team by proactively discussing any changes in project specification/deadline that impact on project budgets and financial forecasts. - Record and monitor actual versus budgeted time on own projects, complete timesheets accurately, and submit on time to line manager, relevant client services lead(s), and finance department weekly. - Keep abreast of industry self-regulation and compliance guidelines as well as client SOPs, and maintain good working practices at all times. Qualifications - A life sciences degree, ideally combined with a science master’s or PhD - Strong and effective communication skills both verbally and in writing - Good knowledge of pharmaceutical industry and processes - Excellent attention to detail and organizational skills - Ability to multitask and work independently in a fast-paced agency environment - Ability and desire to learn new therapy areas and disease states as required - Proactive approach to sharing updates, status, ideas, and feedback with internal and external stakeholders - Proficiency in Microsoft Office (Word, PPT, Excel, Teams, Outlook) and Adobe Benefits - Generous time off policy - Health Insurance and Protection - Paid Holidays - 401K with match - Learning & Development opportunities - Remote working
Medical Writer – 6 Month Fixed Term Contract
BDBD is a global medical technology company that is advancing the world of health. www.bd.com
• Develop high-quality educational materials, including presentations, training decks, and supporting resources • Review and approve medical content to ensure alignment with internal standards and regulatory requirements • Support Train-the-Trainer programs by enabling clear communication of clinical content to physicians • Work with data analysts to ensure external materials present clinically relevant and interpretable data • Build compelling, evidence-based narratives that strengthen the impact of educational content • Translate complex scientific literature into concise, practical insights for education purposes • Maintain a structured and searchable reference library of clinical evidence and materials • Contribute to initiatives that demonstrate the clinical value and application of medical technologies
• Facilitate improvements in clinical documentation quality, completeness, and accuracy to support patient care and reimbursement outcomes. • Analyze clinical records and identify documentation opportunities related to severity of illness, risk of mortality, and coding accuracy. • Assign working DRGs for inpatient admissions and support appropriate code assignment. • Collaborate with physicians, Nurse Case Managers, and multidisciplinary care teams to obtain complete and accurate clinical documentation. • Query providers to clarify incomplete, conflicting, or ambiguous documentation using approved processes. • Perform clinical record abstracting and data collection to support reimbursement, quality initiatives, and outcome reporting. • Educate physicians and care teams on documentation standards, coding updates, MS-DRG changes, and coding guidelines. • Ensure the accuracy and integrity of medical record data prior to billing and claims submission. • Partner with Patient Accounting and coding teams to resolve reimbursement and documentation-related issues. • Support quality management and continuous improvement initiatives through data analysis, education, and documentation integrity efforts.



