Senior Technical Author

2 weeks ago


City Of London, United Kingdom RBW Consulting LLP Full time

About the Opportunity:

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  • We are seeking a Senior Technical Author - Pharmaceutical Industry to join our dynamic Regulatory Department as a freelancer until March 2025, with the possibility of renewal.
  • As a key member of our team, you will be responsible for preparing, reviewing, and finalizing regulatory submission documents for late-stage clinical applications (Phase 3) and marketing applications.
  • This role offers a unique chance to contribute to the development of groundbreaking therapies by ensuring the highest quality in regulatory submissions.
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About the Position:

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  • The ideal candidate will have at least 5 years of technical writing experience in CMC regulatory submissions, with a degree in Pharmacy, Chemistry, Biology, or a related field.
  • Strong organizational and project management skills, as well as exceptional technical writing skills, are essential for this role.
  • A business level proficiency in written and spoken English is also required.
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Key Responsibilities:

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  • Prepare, review, and finalize regulatory submission documents for late-stage clinical applications (Phase 3) and marketing applications.
  • Write CMC sections of regulatory submissions, including Module 2.9.
  • Manage CMC regulatory submission workflows within the document management system.
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Salary:

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$120,000 per year, based on industry standards and considering the location and job requirements.



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