Medical Writer II - FSP

【職務内容】

医薬品開発における各種ドキュメントの作成・レビューを担当いただきます。

主な作成文書：

• 定期安全性報告書（DSUR関連文書）
• 治験実施計画書（Protocol）
• 同意説明文書（ICF）
• 治験総括報告書（CSR）
• 治験責任医師向け資料（Investigator's Brochure）
• CTD（コモン・テクニカル・ドキュメント）
• 安全性評価報告書
• その他規制当局提出用文書

【求める人物像】

• 臨床開発および医薬品開発プロセスへの理解がある方
• ICH-GCPや関連規制の知識を有する方
• 高品質な文書作成能力をお持ちの方
• 細部への注意力が高く、正確性を重視できる方
• 複数案件を管理し、納期を意識して業務を進められる方
• 社内外の関係者と円滑にコミュニケーションを取れる方
• 自発的に課題を発見し、解決に向けて行動できる方

【必須要件】

• 日本の定期安全性報告書（特にDSUR別紙様式及び未知非重篤副作用報告書）作成経験1年以上
• メディカルライティング経験3年以上
• ビジネスレベルの英語力

【歓迎要件】

• 安全性報告書以外のメディカルライティング経験
• Protocol、CSR、ICF、CTD作成経験
• CROまたは製薬会社での就業経験
• グローバルプロジェクト参画経験
• グローバルチームや海外ラインマネージャーとのコミュニケーション
• 英語での社内トレーニングへの参加

【ポジションの魅力】

• グローバル環境で英語力を活かせる
• 安全性報告書領域の専門性を高められる
• 医薬品開発の重要文書作成を通じて規制当局申請に貢献できる
• フレキシブルな働き方が可能な環境

Job 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

The MW will

• gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalizes 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, and integrated summaries of safety and efficacy.

• It has to be ensured that all work is complete and of high quality prior to team distribution or shipment to the client: data consistency and integrity, publishing readiness, adherence to regulatory guidelines, and compliance with departmental, corporate or client SOPs.

• The MW acts in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management. Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs. Distribute final documents to project team and client.

Qualifications :

Skills:

• 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 deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills.

• Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity.

• Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.

• Understands and satisfies client needs.

• Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services.

• Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy.

Knowledge and Experience:

• Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.

• Extensive clinical/scientific writing skills.

• Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar.

• Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases ( Excel).

• Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.

Education:

• Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.