百瑞精鼎國際股份有限公司

百瑞精鼎提供多元職場環境，歡迎身心障礙夥伴的加入。 為提供及增加身心障礙夥伴的就業機會，開立此投遞專區，歡迎相關人才踴躍投遞。 1. 歡迎持身心障礙手冊人才主動投遞，有意應徵者請以104系統投遞履歷，並請於個人履歷註明「欲應徵的職務」，如有合適職缺，本公司將主動聯繫通知，不合適者則不另通知。 2. 本公司目前開放之職缺內容，請參考104職缺說明，如有符合專長、經歷或興趣等工作機會，請主動投遞履歷，以增加面試機會。

Your time here: At Parexel, the CRA role offers the opportunity to go beyond the role of a typical clinical monitor. CRA’s are accountable for using their expertise to build and maintain the site relationship and ensure they’re set up for success. As the clinical sites’ sole point of contact, this includes addressing and resolving site issues and questions. You’ll also manage site quality and delivery from site identification through to close-out. As a CRA, Parexel will offer you world class technology and training catered to your individual experience. You can anticipate less travel and a lower protocol load in comparison to industry peers. Your hard work may be rewarded through a bonus incentive program, the opportunity to work within multiple therapeutic areas and an opportunity to advance your career in clinical research. If impact, flexibility, and career development appeal to you, Parexel could be your next home. What you’ll do: -Leverage your expertise. Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports. -Build relationships. Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff. -Protect patients. Review the performance of the trial at designated sites, ensure the rights and well-being of human subjects are safeguarded and are in accordance with protocol. -Drive productivity. Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines, while also ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s). -Ensure quality. Evaluate the quality and integrity of the reported data, site efficacy and drug accountability. -Execute. Monitor the completeness and quality of Regulatory Documentation and perform site document verification.

• Deliver best value and high quality service • Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed. • Assist in the coordination of project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g., setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation. • Assist in the production and QC of derived dataset specifications, programming specifications, and other process supporting documents. • Use efficient programming techniques to produce derived datasets, tables, figures and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures and data listings • Check own work in an ongoing way to ensure first-time quality. • Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance. • Proactively participate in quality improvement initiatives. • Ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required • Develop wider knowledge of SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenas. • Provide relevant training and mentorship to staff and project teams as appropriate. • Assist project teams in the resolution of problems encountered in the conduct of their daily work.

The Biostatistician works independently in the programming and quality control of derived datasets and all kind of statistical outputs (e.g., tables, listings and figures), works under the supervision of an experienced biostatistician in the production of analysis plans and reports, provides basic statistical advice to clients and fulfills the project primary role within a designated project team. Key Accountabilities • Production and/or QC of derived datasets and both simple and advanced statistical outputs using efficient programming techniques. • Understand and apply moderately advanced statistical methods. • Coordinate and lead a project team to successful completion of a project within given timelines and budget. • Interact with clients as key contact with regard to statistical and contractual issues. • Assist in the production of analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents. • Check own work in an ongoing way to ensure first-time quality. • Provide training in statistical analysis to internal clients. • Proactively participate in and/or lead process/quality improvement initiatives. • Mentor and train junior members of the department. • Support of Business Development, e.g. by attending and preparing bid defense meetings. • Travel to, attend and actively contribute to all kind of client meetings as appropriate (e.g. discussing analysis concepts, presenting and discussing study results) • Additional responsibilities as defined by supervisor/manager.

Timely deliver all national Regulatory Authority activities (may include NDA, DMF, PMF, BSE, post-marketing variations, CTA and amendments, etc.) within scope with first time quality. *Lead on regulatory projects as a Regulatory Lead or Project Lead, responsible for project management, finance oversight, main point of contact for client, and coordination for national RA submission activities. Job Description *Works effectively within a team environment but may work independently delivering services within their area of competence (may include NDA, DMF, PMF, BSE, post-marketing variations, CTA and amendments, etc.). *Lead on regulatory projects as a Regulatory Lead or Project Lead. Responsible for project planning, set-up, finance control. Functions as the main client contact and ensures accurate project reporting is in place. Ensures that the project team delivers to meet the client expectations for quality and timeliness. *Provides technical and/or business consulting services within personal area of expertise. *Takes initiative to prioritize work to achieve specified project outcomes while confirming alignment with project team. *Produces quality work that meets the expectations of project team and the client. *Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability. *Proactively assesses client needs and develops processes and solutions to address issues. *May participate in project scoping calls and/or proposal preparation with the support of senior colleagues. *Participation in internal initiatives/projects or as a mentor as requested by management.

【概要】 ポジション名：Market Development Manager 部署：インサイドセールス 職務形態：正社員 / 非管理職 【職務概要】(Job Purpose) パレクセルの各事業部門と連携しながら、クライアントに対して最適なソリューションを提案するためのマーケットリード創出をお任せいたします。具体的には、新規および既存顧客に対するビジネスチャンスの発掘、案件パイプラインの構築、戦略立案、初期対応、営業チームへの引き継ぎなど、幅広くご担当いただきます。 【 主な業務内容 】(Key Accountabilities) ＜新規開拓・リードジェネレーション＞ ・Web経由の問い合わせの一次対応（ニーズのヒアリングなど） ・マーケティング部門、セールス部門などと連携し、ターゲット顧客に向けたリード獲得施策を企画・実行 ・Webツール(LinkedInやGoogleなど)を活用した顧客リストの作成 ・潜在的なビジネス機会の分析、戦略立案、進捗状況のモニタリング ＜社内連携・プロジェクト推進＞ ・マーケティングチーム・セールスチームと連携し、ウェビナー、イベントなどの施策を通じたブランド認知およびリード獲得活動の支援 ・セールスチームによる商談やデモのスケジューリング ・セールスアソシエイトやアカウントエグゼクティブへの顧客情報の引き継ぎ ■ 応募要件 【必須要件】 ・グローバルチームの一員として協働できる高いコミュニケーション力・推進力 ・高いプレゼンテーション・ファシリテーション能力（社内外向け） ・ビジネス系出版物、業界ジャーナル、技術文書の読解力 ・ビジネスチャンスを迅速に把握し、柔軟に対応できる判断力 ・製薬、CRO、医療機器業界での業務経験：2年以上 ・日本語：ネイティブレベル / 英語：ビジネスレベル（読み書き会話） 【歓迎要件】 ・課題を予測し、柔軟な代替策を提案できる思考力 ・マーケティング・営業・ビジネスディベロップメントの経験：2年以上 ・学士号（経営学・マーケティングなどの専攻が望ましい） ■ キャリアパス セールスラインマネージャーやアカウントエグゼクティブなどへのキャリアアップが可能です。 ■ ポジションの魅力 ・スキルの習得：インサイドセールス業務を通じて、リード獲得・顧客対応・戦略立案など、幅広いスキルを習得できます。 ・顧客とのつながり：クライアントとの対話を通じて、ニーズに応じた課題解決に貢献し、信頼関係を築けます。 ・成果報酬制度：成果に応じたボーナスやインセンティブ制度があり、高いモチベーションで業務に取り組めます。 ■働き方 ・フルフレックスタイム制 ・原則週３日出社、週２日リモートワーク　(※業務に合わせて出社日を選択できます) 　・補足）月に２回、日本時間深夜の時間帯(23時前後)に、グローバルチームとの定例ミーティングにご参加いただきます。 ■補足 ・就労ビザ 取得サポート支援あり ◆選考プロセス◆ 1, 書類選考（英文レジュメ必須）→ 2, オンライン面接 ２回（日本語・英語） -----------------------------------------------------------------------

** Part Time Intern Program** We are seeking a motivated and detail-oriented Laptop Setup Intern to join our IT team and support our Windows 11 deployment project. This is an excellent opportunity for students with a computer science background or related fields to gain hands-on experience. Preferred Skills: -Experience with Windows 11 or previous versions of Windows -Knowledge of computer networking basics Additional Information: -This is a part-time internship, requiring 2-3 days per week in the Taipei office **可一周進台北辦公室上班至少2-3天 ** ***歡迎您透過: 官網-jobs.parexel.com提交線上履歷，我們將優先與官網申請者安排面談。***