[Hiring] Document Review Specialist II @Thermo Fisher Scientific

Role Description

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.

We are excited to be expanding our Medical Writing Functional Service Partnership (FSP) Team in the United Kingdom or Serbia. We are seeking a talented and experienced Document Review Specialist II with at least 2 years’ experience in regulatory Medical Writing to join our team. This is a remote role dedicated to a particular client in the FSP space.

As a remote-based Document Review Specialist II within the FSP Team, you will:

• Effectively review regulatory documents, including but not limited to submissions documents, protocols and amendments, clinical study reports, investigator’s brochures, and patient safety narratives.
• Ensure quality standards and adherence to templates, client guidelines, editorial style guides, and industry standards.
• Collaborate with internal clients, supporting and enabling effective communication that results in operational excellence and quality deliverables.

Qualifications

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification required.
• Previous editorial experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
• Experience working in the pharmaceutical/CRO industry preferred.
• If CRO experience: experience working in a client-dedicated role or with 1 to 2 clients over multiple projects is preferred.
• In some cases, an equivalency, consisting of a combination of appropriate education, training, and/or directly related editorial experience, will be considered sufficient for an individual to meet the requirements of the role.

Requirements

• Capable of focusing on document details and the overall objectives and intent of document messaging.
• Good knowledge of the methods, techniques, and procedures of medical writing tasks.
• 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 with a team in a cross‑cultural, geographically dispersed environment.

Benefits

• Award-winning learning and development programme, ensuring you reach your potential.
• Competitive salary.
• Extensive benefits package based around the health and well-being of our employees.
• Flexible working culture, valuing a work-life balance.
• Collaborative environment, with teams eager to share expertise and have fun together.