Document Review Specialist II – Client Embedded

This is a fully remote position, open to applicants in United Kingdom, +1 more country.

📋 Description

• Evaluate highly technical scientific documents to guarantee that quality standards meet or surpass client expectations.

• Confirm scientific logic and clarity by cross-referencing data in tables, listings, and figures with source documents.

• Ensure consistency in accordance with current regulatory standards and guidelines.

• Edit documents for precision, uniformity, and grammatical accuracy.

• Modify schedules to accommodate unexpected priority review requests.

• Refine scientific language for appropriate usage, flow, clarity, and target audience suitability.

• Proactively consult with authors regarding unique preferences and scientifically sound judgment.

• Maintain, communicate, and implement knowledge of current guidelines, templates, and industry standards.

• Collaborate with internal clients to foster effective communication and operational excellence.

• Review regulatory documents, including submission documents, protocols and amendments, clinical study reports, investigator’s brochures, and patient safety narratives.

⛳️ Requirements

• Bachelor's degree or an equivalent relevant formal academic/vocational qualification is required.

• A minimum of 2 years' experience in regulatory Medical Writing.

• Previous editorial experience comparable to at least 2 years.

• Experience in the pharmaceutical/CRO industry is preferred.

• For CRO experience, preference for a client-dedicated role or working with 1 to 2 clients across multiple projects.

• Equivalency may include a combination of appropriate education, training, and/or directly related editorial experience.

• Familiarity with methods, techniques, and procedures of medical writing tasks.

• Strong analytical skills.

• Working knowledge of medical terminology and statistical concepts.

• Understanding of GCP and guidelines such as ICH.

• Knowledge of FDA and other international regulatory agency requirements.

• Proficient oral and written communication and grammar skills.

• Advanced computer literacy and expertise.

• Knowledge and understanding of document management systems.

• Ability to work both independently and collaboratively in a cross-cultural, geographically dispersed environment.

• High proficiency in English.

🏝️ Benefits

• Award-winning learning and development program.

• Competitive salary.

• Comprehensive benefits package focusing on employee health and well-being.

• Flexible working culture.

• Work-life balance.

• Collaborative environment.

• Opportunities to share expertise and grow both professionally and personally.