FSP Medical Writer

Why This Role Matters

Regulatory and clinical documents are the foundation of global drug development. Every protocol, clinical study report, and regulatory submission submitted to health authorities influences decisions that impact patient access to innovative therapies. High-quality medical writing ensures clarity, scientific integrity, regulatory compliance, and timely approvals.
At Thermo Fisher Scientific, through its clinical research division PPD, the FSP Medical Writer plays a critical role in supporting global clients within a Functional Service Partnership model. This role ensures that complex clinical data is transformed into clear, compliant, and submission-ready regulatory documentation.
If you are scientifically strong, detail-oriented, and confident in regulatory writing, this position provides exposure to global regulatory standards and structured content authoring systems while supporting life-changing therapies worldwide.

Job Description

The FSP Medical Writer is responsible for developing, editing, and finalizing high-quality clinical and regulatory documents dedicated to one or more clients within the FSP model. The role involves authoring Clinical Study Reports (CSRs), protocols, Investigator’s Brochures (IBs), regulatory submissions, and other essential clinical documentation.
The position requires collaboration with cross-functional teams including clinical operations, biostatistics, regulatory affairs, safety, and project management to ensure scientific accuracy and regulatory compliance. The writer must ensure that documents align with ICH, FDA, and other international regulatory standards while meeting internal quality benchmarks and client expectations.
Experience in structured content authoring systems, automation tools, and AI-supported content workflows is advantageous, as the organization continues to enhance digital medical writing capabilities.

Key Features of the Role:

• Client-dedicated position within the FSP model
• Exposure to global regulatory submissions
• Opportunity to work with structured content authoring systems
• Involvement in AI-driven content creation and automation initiatives
• Strong pathway into senior medical writing or regulatory leadership roles
• Cross-functional collaboration across global clinical development teams

Responsibilities

Medical & Regulatory Writing:
• Write and edit Clinical Study Reports (CSRs)
• Develop study protocols and amendments
• Author Investigator’s Brochures (IBs)
• Prepare regulatory submission documents
• Contribute to safety writing such as DSURs (if applicable)

Document Quality & Compliance:
• Ensure documents align with regulatory guidelines and company standards
• Apply ICH, FDA, and global regulatory requirements
• Maintain clarity, consistency, and scientific accuracy
• Provide structured, submission-ready documentation

Collaboration & Review:
• Partner with cross-functional teams to gather and verify clinical data
• Provide input on document structure and presentation
• Review and provide feedback on documents prepared by other writers
• Manage timelines and deliverables for assigned projects

Digital & Innovation Support:
• Work within structured content management systems
• Support AI-driven content creation initiatives
• Utilize automation tools to enhance efficiency
• Stay updated on evolving medical writing technologies and standards

Required Qualifications

• Bachelor’s degree in a scientific discipline (Advanced degree preferred)
• Minimum 2+ years of regulatory medical writing experience
• Experience within pharmaceutical or CRO industry required

Educational Requirements:

Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Medicine, or related scientific discipline. A Master’s or advanced scientific degree is preferred for candidates seeking long-term growth in regulatory writing leadership roles.

Experience and Skills:

Technical Knowledge:
• Extensive knowledge of regulatory guidelines and drug development processes
• Understanding of GCP and ICH guidelines
• Familiarity with FDA and global regulatory agency requirements
• Experience writing CSRs, protocols, IBs, and regulatory submissions

Preferred Expertise:
• Experience in safety writing (e.g., DSUR)
• Experience with structured content management systems
• Familiarity with AI-driven content creation and Natural Language Generation tools

Professional Competencies:
• Strong organizational and program management skills
• Proven leadership capability to mentor or guide team members
• High level of independence in decision-making
• Strong analytical thinking and problem-solving skills
• Excellent written and verbal communication
• Strong interpersonal skills for stakeholder collaboration
• Ability to work effectively in cross-cultural, global teams

Salary Insights:

Compensation will be competitive and aligned with industry standards for medical writing roles within global CRO environments.
Additional benefits may include:
• Comprehensive health and wellness benefits
• Flexible working culture supporting work-life balance
• Award-winning learning and development programs
• Exposure to advanced digital medical writing platforms
• Long-term career progression opportunities

Company Overview

Thermo Fisher Scientific is a global leader in scientific services, 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 innovative therapies across therapeutic areas.
The company’s mission is to enable customers to make the world healthier, cleaner, and safer. Guided by its core values—Integrity, Intensity, Innovation, and Involvement Thermo Fisher Scientific fosters collaboration, scientific excellence, and technological advancement.
Employees benefit from a collaborative global culture with a local feel, structured professional growth programs, and strong support for work-life balance.

FAQs

Q1: Is this a remote role?
The role follows a standard office schedule (Mon–Fri) but may operate within flexible FSP arrangements depending on client needs.

Q2: Is safety writing mandatory?
Safety writing experience (e.g., DSUR) is advantageous but not mandatory.

Q3: Is structured content authoring experience required?
Not mandatory, but strongly preferred for candidates interested in digital innovation.

Q4: Does the role involve leadership responsibilities?
Yes, experienced candidates may mentor junior writers and manage document workflows.

Q5: What are the career progression opportunities?
Potential growth includes Senior Medical Writer, Lead Medical Writer, Regulatory Writing Manager, or Global Submission Lead roles.

Application Tips

• Highlight CSR, protocol, and IB writing experience clearly
• Mention regulatory submission involvement
• Emphasize structured content or AI-tool exposure
• Demonstrate ability to manage timelines independently
• Showcase collaboration with cross-functional clinical teams