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Medical Writer （有期契約雇用社員、1年契約）
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採用企業案件
サイネオス・ヘルス・ジャパン株式会社 クリニカル事業部
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- 会社規模非公開
- CRO
- その他
| 部署・役職名 | Medical Writer （有期契約雇用社員、1年契約） |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Medical writer on clinical study or regulatory project teams. Writes, edits, and coordinates content for clinical/regulatory documents to ensure high-quality completion of all assigned writing projects. • Compiles, writes, edits, and coordinates medical writing deliverables that present scientific information clearly and accurately, and works as a medical writer within and across departments with minimal or moderate supervision. • Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. • Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget. • Coordinates quality and editorial reviews. Ensures source documentation is managed appropriately. Leads document reviews, reviews documents as needed, and resolves comments from client. • Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format. • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Provides feedback to further define statistical output required. • Interacts and builds good working relations with clients, department head, and peers, as necessary, to produce writing deliverables. • Performs online clinical literature searches and complies with copyright requirements. • Identifies and proposes solutions to resolve document issues, escalating as appropriate. • Mentors less experienced medical writers on projects, as necessary. • Maintains a strong working knowledge of drug development process, regulatory guidelines, industry standards, and best practices. • Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership. • Completes required administrative tasks within the specified timeframes. • Performs other work-related duties as assigned. • Minimal travel may be required (less than 25%). |
| 労働条件 | 製薬メーカーにて就業（東京都） |
| 応募資格 |
【必須（MUST）】 • At least 2 years of relevant experience in science, technical, or medical writing.• Experience working in the biopharmaceutical, device, or contract research organization industry preferred. • Familiar with FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly preferred. • Experience writing relevant document types preferred. • Extensive knowledge of English grammar and ability to communicate clearly; familiar with AMA Manual of Style. • Effective presentation, proofreading, collaborative, and interpersonal skills. • Strong proficiency in MS Office. • Familiar with medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information. • 4 Year / Bachelors Degree 【歓迎（WANT）】 • Bachelor’s degree in a relevant discipline with relevant writing experience; graduate degree preferred. |
| アピールポイント | 自社サービス・製品あり 外資系企業 女性管理職実績あり 上場企業 従業員数1000人以上 2年連続売り上げ10％以上UP 年間休日120日以上 産休・育休取得実績あり 教育・研修制度充実 資格支援制度充実 社内公用語が英語 シェアトップクラス マネジメント業務なし 完全土日休み フレックスタイム 月平均残業時間20時間以内 |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 喫煙室設置 |
| 更新日 | 2026/07/29 |
| 求人番号 | 9302274 |
採用企業情報
- サイネオス・ヘルス・ジャパン株式会社 クリニカル事業部
-
- 会社規模非公開
- CRO
- その他
-
会社概要
【代表者】スティファン・グトウ
【本社所在地】東京都千代田区丸の内2-7-2 JPタワー12階
【事業内容】医薬品及び医療機器に関わる臨床開発の受託事業
【当社について】
サイネオス・ヘルスは、業界で唯一、横断的なバイオ医薬品ソリューションを提供する会社です。私たちは、現代のマーケットの期待に応えようとするお客様に対し、お客様のパフォーマンスがより加速することを支援する、医薬品開発受託機関(CRO)およびコマーシャルビジネス受託機関(CCO)です。業界をリードするINC ResearchとinVentiv Healthの2社の合併によって設立された弊社は、クリニカル事業とコマーシャル事業の知識と経験を備えた28,000人以上の社員を、世界110カ国以上の拠点に擁し、皆様をサポート致します。
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です