Note: The job is a remote job and is open to candidates in USA. BioSpace is a company focusing on the pharmaceutical industry, and they are seeking a Clinical Editor Intern for their Medical Writing Operations team. The intern will support the finalization activities of clinical documents, including quality control checks, formatting, and ensuring compliance with regulatory standards.
Responsibilities
- Support medical writing operations with day-to-day activities such as quality control checks, word processing, managing CSR appendices, and obtaining/uploading literature references
- May support administrative tasks or other Medical Writing Operations process improvement initiatives
- Edits, formats, and performs QC checks of clinical documents intended for submission to regulatory agencies and ad hoc documents, as follows:
- 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 (eg, SAS tables and listings), and content complies with applicable regulations (eg, ICH E3 [CSR] and E6 [GCP], 21 CFR)
- 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
- Formatting of documents to comply with submission-ready standards
- Management of CSR appendices
- Supports QC process improvement initiative
Skills
- 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
- This position will be Remote
- 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
- Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship
- Must be currently enrolled in a degree program graduating December 2026 or later
- The intern must be able to commit to one of these time frames
- Able to work full time 40 hours a week during internship dates
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.
Company Overview
BioSpace is the leading online community for industry news and careers for life science professionals. It was founded in 1988, and is headquartered in San Francisco, California, USA, with a workforce of 11-50 employees. Its website is http://www.biospace.com/.
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