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The Medical Writing Operations team is responsible for supporting the finalization activities of all documents written by the Medical Writing team, including the verification of data, an accuracy and consistency check of content, a review for grammar and company style-guide alignment, and the formatting of documents according to submission-ready standards. Our team also supports medical writers in obtaining literature references, with the management of CSR appendices, and helps to resolve technical issues with medical writing websites and tracking systems. We work across functions to optimize QC and editing processes and ensure the latest technologies are being used to support our mission.
Duties will include the following, under the manager's supervision
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.
How You Will Contribute:
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, ensureing 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.
Job 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.
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.
Internship Eligibility
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 internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st)
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
Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program
Program Highlights:
Hands-on experience with real projects and responsibilities
Dedicated mentorship program pairing interns with experienced professionals
Networking opportunities with industry professionals and fellow interns
Internship events focused on professional and skills development
Exposure to multiple business areas or departments within a Pharmaceutical Organization
Applications will be accepted between November 7th - November 30th
Takeda Compensation and Benefits Summary
We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Massachusetts - VirtualU.S. Hourly Wage Range:
$21.00 - $46.00
The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate’s school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. internship benefits vary by location and may include:
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.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Job Exempt
NoIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.