Regulatory Document Review Specialist II/Senior Document Review Specialist (FSP)

At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life—enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies.

About the role

We are expanding our Medical Writing Functional Service Partnership (FSP) Team in North America and seeking an experienced and skilled Document Review Specialist II. This remote-based role will be dedicated to one or more clients in the FSP space, with a preference for experience working in a range of document management systems. You will review regulatory documents—including submissions, protocols, amendments, clinical study reports, investigator’s brochures, and patient safety narratives—to ensure quality standards and adherence to templates, client guidelines, editorial style guides, and industry standards. Collaboration with internal clients is key to achieving operational excellence and quality deliverables. This role requires meticulous attention to detail, high English proficiency, and a solid understanding of regulatory document content.

This is a document review role only and you will not be responsible for writing.

Responsibilities

• Reviews highly technical scientific documents of all types to ensure quality standards meet or exceed client expectations.
• Verifies scientific logic and clarity by cross-checking data in tables, listings, and figures against source documents and ensuring consistency with current regulatory standards and guidelines.
• Edits for accuracy, consistency, and grammatical correctness.
• Adjusts schedule to accommodate unexpected priority review requests.
• Revises scientific language for usage, flow, clarity, and audience appropriateness.
• Proactively queries authors to ensure compatibility with unique preferences and scientifically sound judgment.
• Maintains, communicates, and applies knowledge of current guidelines, templates, and industry standards.

Requirements

• Bachelor’s degree or equivalent and relevant formal academic/vocational qualification.
• 5 years of regulatory document review experience, including protocols, protocol amendments, clinical study reports, narratives, investigator brochures, regulatory responses, and submission modules (primarily Modules 2.5, 2.7.3, and 2.7.4).
• Experience working in the pharmaceutical/CRO industry preferred.
• If CRO experience: preference for working in a client-dedicated role or with 1 to 2 clients over multiple projects.
• In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience may be considered.

Skills

• Capable of focusing on document details and the overall objectives and intent of document messaging.
• Good knowledge of medical writing methods, techniques, and procedures.
• Strong analytical ability.
• Good working knowledge of medical terminology, statistical concepts, GCP, guidelines (e.g., ICH), and requirements of the FDA and other international regulatory agencies.
• Attentive to detail and quality of documents; thorough and methodical.
• Proficient oral and written communication and grammatical skills.
• Good organizational and planning skills.
• Good interpersonal skills.
• Proven ability to work effectively in a team environment.
• Advanced computer literacy and expertise.
• Good knowledge and understanding of document management systems.
• Capable of working well under pressure and remaining motivated.
• Capable of working both independently and collaboratively in a cross-cultural, geographically dispersed environment.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability.
• Retirement and savings programs, such as a competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount.

Pay

The salary pay range for this Medical Document Review Specialist II position based in Maryland is $85,000.00–$100,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.