Medical writing, oncology

Company Overview
◆グローバルランキング5位以内
◆ヨーロッパヘッドクオーター
◆癌、呼吸器、循環器、眼科領域を始め幅広い領域にパイプラインを持つ
◆癌領域に最先端の技術

Job Description
Job Purpose
・ To write and manage the production of high quality clinical documentation for submission to regulatory authorities in support of marketing applications and documentation for other purposes.
・ To provide leadership as a medical writer within submission teams, and authoritative documentation-related consultancy to Medical Writing group and other line units.
・ To provide medical documents which are met with end-clients’ objective and needs. Clients include Health Authority, investigators, patients and internal clinical development project related members.
・ To control various internal regulatory/medical documents to have them met the aligned Target Product Profile (TPP) through the development coordinating with related divisions.

Major Accountabilities
・ Act as a member of clinical trial teams following protocol finalization and write/edit clinical study reports.
・ Write/edit summary documents for submissions, other clinical/regulatory documents as required and according to availability of resource.
・ Analyze and interpret data and other information in order to determine the best approach to composing the document.
・ Compose initial draft of a document by referring to all information compiled in preparation for composition.
・ Integrate into the initial draft the input, expertise, and opinions from members of the authoring team and internal/external experts and business partners.
・ Compose the final document by referring to reviewers’ input and other information compiled.
・ Provide advice, support, and composition for designing content that can be reused in other deliverables.
・ Edit document to ensure document quality in regard to correctness of structure, content, language, and/or style.
・ Act as submission coordinator to ensure provision of adequate medical writing resources for dossier preparation and co-ordinate production of summary documentation in collaboration with clinical team.
・ Provide authoritative documentation consultancy to other line units on regulatory submissions and other documentation-related issues.
・ Lead development of document templates and documentation-related processes both within Medical Writing group and more widely.
・ Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
・ 100% timely delivery of all training requirements including compliance.

Requirements
・ Languages: Excellent written /oral English and local language.
・ Experience / Professional

Requirement:
・ At least 2 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus knowledge of the medical writing processes.
・ Extensive experience with clinical/regulatory documentation and publication writing.
・ Solid computer technical skills (Word/Excel/Powerpoint) to prepare documents.
・ Excellent medical writing skills and editing skills.
・ Expert data interpretation and presentation skills.
・ Excellent understanding of biostatistics.
・ Submission expertise.
・ Expert knowledge of regulatory requirements and clinical development, such as ICH guideline.
・ Experience of process improvement and quality management.
・ Experience in managing external medical writers.

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