BioSpace · 1 month ago
2026 Summer Internship Program: Medical Writing Operations Clinical Editor Intern
United States
Internship
Remote
Intern
$21/hr - $46/hr
Start in 2026 SummerBioSpace 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.
BiotechnologyCommunitiesHealth CareMedical
No H1B
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
Qualification
Required
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
BioSpace
BioSpace is the leading online community for industry news and careers for life science professionals.
Founded in 1988
11-50 employees
Funding
Current Stage
Growth StageTotal Funding
$10M2000-08-24Series B· $10M
Leadership Team
J
Joshua Goodwin
CEO/President
K
Kristin Jones
Chief Revenue Officer (CRO)
Recent News
2025-11-07
Catalyst Pharmaceuticals, Inc.
2025-11-06
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