Document Review Specialist II - Medical Writing (FSP)

Why This Role Matters

In clinical research and regulatory submissions, accuracy is non-negotiable. Every protocol, clinical study report, investigator brochure, and safety narrative contributes directly to regulatory decisions that impact patient access to life-changing therapies. A single inconsistency in data tables, formatting, or scientific logic can delay approvals and affect global health outcomes.
At Thermo Fisher Scientific, through its PPD clinical research portfolio, this role ensures regulatory documents meet the highest quality standards before submission. As a Document Review Specialist II within the Medical Writing Functional Service Partnership (FSP) team, you serve as a critical quality checkpoint for global clinical programs conducted across 100+ countries.
This position is ideal for detail-oriented professionals with strong regulatory knowledge who thrive in structured, high-accountability environments and want to contribute to global clinical development excellence.

Job Description

The Document Review Specialist II is responsible for reviewing highly technical scientific and regulatory documents to ensure clarity, accuracy, consistency, and compliance with industry standards. Working within the FSP model, you will be dedicated to one or more clients and collaborate closely with medical writers, regulatory teams, and cross-functional stakeholders.
You will review documents such as Clinical Study Reports (CSRs), study protocols, amendments, Investigator’s Brochures (IBs), Informed Consent Forms (ICFs), regulatory submissions, and patient safety narratives. The role requires verifying data accuracy across tables, listings, and figures; ensuring alignment with templates and editorial style guides; and confirming adherence to ICH, FDA, and international regulatory standards.
This role demands meticulous attention to detail, advanced English proficiency, scientific comprehension, and the ability to manage priority reviews under tight timelines.

Key Features of the Role:

• Dedicated client-facing role within the FSP model
• Exposure to global regulatory documentation standards
• Involvement in high-impact clinical research submissions
• Opportunity to work in a remote, cross-cultural team environment
• Strong pathway into advanced medical writing or regulatory operations roles
• Engagement with document management systems and structured workflows

Responsibilities

Document Quality Review & Editing:
• Review highly technical scientific documents for quality and compliance
• Verify scientific logic and clarity of document content
• Cross-check data in tables, listings, and figures against source documents
• Edit for grammatical correctness, consistency, and formatting accuracy
• Ensure compliance with client templates and editorial style guides

Regulatory Compliance & Standards Alignment:
• Apply current ICH, FDA, and global regulatory guidelines
• Maintain awareness of industry standards and template updates
• Ensure document alignment with regulatory expectations

Collaboration & Communication:
• Proactively query authors regarding inconsistencies or scientific concerns
• Support effective communication between internal teams and clients
• Adjust schedules to accommodate urgent or priority review requests
• Contribute to operational excellence and timely deliverables

System & Process Management:
• Work within document management systems
• Support template compliance through direct formatting in Microsoft Word
• Maintain organized documentation tracking and review workflows

Required Qualifications

• Bachelor’s degree or equivalent academic/vocational qualification
• Minimum 2+ years of experience reviewing regulatory documents such as CSRs, Protocols, ICFs, and IBs
• Experience within pharmaceutical, biotechnology, or CRO industry preferred

Educational Requirements:

A Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Biomedical Sciences, English (Scientific Writing), or a related discipline is required. Additional certifications in medical writing or regulatory affairs are advantageous.

Experience and Skills:

Technical & Regulatory Knowledge:
• Strong understanding of medical writing processes
• Familiarity with GCP guidelines and ICH standards
• Knowledge of FDA and international regulatory requirements
• Understanding of statistical concepts used in clinical documents

Document & Editorial Skills:
• Advanced English proficiency (written and verbal)
• Strong grammatical and editing capability
• Ability to focus on both micro-level details and overall document intent
• Experience with direct formatting in Microsoft Word

Systems & Digital Skills:
• Working knowledge of document management systems
• Advanced computer literacy
• Comfortable working in digital and decentralized environments

Professional Competencies:
• Strong analytical thinking
• Excellent organizational and planning skills
• Ability to work under pressure
• Effective team collaboration in cross-cultural settings
• Capacity to work independently in remote environments

Salary Insights:

Compensation will be competitive and aligned with industry benchmarks for medical writing and document review roles within global CRO environments.
Additional benefits may include:
• Comprehensive health and wellness benefits
• Flexible working culture supporting work-life balance
• Structured learning and development programs
• Exposure to global clinical research frameworks

Company Overview

Thermo Fisher Scientific is a global leader in scientific services and life sciences solutions, employing over 100,000 colleagues worldwide. Through its clinical research division PPD, the organization conducts clinical trials in more than 100 countries and supports the development of life-changing therapies.
The company’s mission is to enable customers to make the world healthier, cleaner, and safer. Its values—Integrity, Intensity, Innovation, and Involvement—guide teams across laboratory services, digital solutions, and decentralized clinical trial operations.
Employees benefit from award-winning learning and development programs, a collaborative global culture, and strong support for career growth in regulatory science and clinical research operations.

FAQs

Q1: Is CRO experience mandatory?
Not mandatory, but experience within pharmaceutical or CRO environments is strongly preferred.

Q2: Is this a medical writing role?
This is a document review and quality assurance role within medical writing, not primary authoring.

Q3: Does the role require client interaction?
Yes, especially within the FSP model where professionals may support dedicated clients.

Q4: Is remote work allowed?
Yes, the role is remote-based within a structured office schedule (Mon–Fri).

Q5: What career growth opportunities exist?
This role can lead to Senior Document Review Specialist, Medical Writer, Regulatory Writing Lead, or Quality Compliance roles within clinical research.

Application Tips

• Highlight experience reviewing CSRs, Protocols, ICFs, and IBs
• Emphasize regulatory guideline familiarity (ICH, FDA, GCP)
• Showcase editing, formatting, and template compliance skills
• Mention experience with document management systems
• Demonstrate ability to manage priority reviews under deadlines