Medical Writing Operations Clinical Editor Intern

Job not on LinkedIn

November 8

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $21 - $46 / hour

👨‍🎓 Internship

⚪️ Entry-level

✏️ Content Writer

🦅 H1B Visa Sponsor

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Takeda

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Takeda is a global biopharmaceutical company dedicated to bringing better health and a brighter future to patients worldwide. With a strong focus on research and development, manufacturing, and quality, Takeda operates with a commitment to ethics and a diverse workforce that spans over 80 countries. The company leverages innovative science and partnerships to create impactful medicines, including therapies in oncology and vaccines, ensuring that they effectively meet the needs of the patients they serve.

10,000+ employees

Founded 1781

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Grant on 2016-08

📋 Description

• Support medical writing operations with day-to-day activities such as quality control checks, word processing, managing CSR appendices, and obtaining/uploading literature references. • Edits, formats, and performs QC checks of clinical documents intended for submission to regulatory agencies and ad hoc documents. • Reviews documents in accordance with Takeda SOP company-defined templates, Takeda Style Guide, and existing finalization and QC processes within established timelines. • Ensures internal consistency and confirms that data are reported correctly, statements accurately reflect source documents or data, and content complies with applicable regulations. • Ensures copyright clearance, submission-readiness, and availability in bibliographic database of literature references used to support document development. • Ensures document formatting meets the electronic publishing and regulatory submission requirements per Takeda’s Submission-ready Standards. • Ensures documents are securely maintained and version controlled to maintain the integrity of documents in accordance with Takeda’s SOPs and processes. • May support additional Medical Writing Operations activities, including but not limited to the collection of literature references cited within the documents originating within Medical Writing, ensuring copyright clearance, submission-readiness, and availability in the EndNote library and electronic data management system for all literature references.

🎯 Requirements

• Must be pursuing a Bachelor’s or Master’s degree in English or the Sciences, but open to any liberal arts degrees who have an interest in exploring careers in the pharmaceutical industry. • Must have an interest in learning about clinical documentation, templates, standards, and relevant regulations or guidance documents. • Possesses knowledge of desktop applications including MS Word and Adobe Acrobat Professional and interest in technology and working with technical tools and systems, such as Microsoft Copilot, Excel, PowerPoint, SharePoint, and Veeva. • Exhibits strong attention to detail. • Possesses effective communication skills both verbally and in writing, including proofreading and copyediting skills. • Demonstrates effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously. • Understands the value of quality and compliance, and the implications and risks of non-compliance. • Shows flexibility to adapt to a changing and busy environment. • Has a creative and problem-solving mindset.

🏖️ Benefits

• Paid sick time • Civic Duty paid time off • Participation at company volunteer events • Participation at company sponsored special events • Access to on-site fitness center (where available) • Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking.