Document Review Specialist II - Medical Writing

Work Schedule

Environmental Conditions

Job 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. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Summarized Purpose:
We are excited to be expanding our Medical Writing Functional Service Partnership (FSP) Team in North America. We are seeking an experienced and skilled Document Review Specialist II who will be dedicated to one or more clients in the FSP space to join our team; experience working in a range of document management systems would be preferred. As a remote-based Document Review Specialist 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, to ensure quality standards and adherence to templates, client guidelines, editorial style guides, and industry standards. You will collaborate with internal clients, supporting and enabling effective communication that results in operational excellence and quality deliverables. This role requires meticulous attention to detail, a high English proficiency with the ability to communicate clearly and concisely, and a solid understanding of regulatory document content.

Key Responsibilities:

• Reviews highly technical scientific documents of all types developed within or outside of the company to ensure quality standards that meet or exceed client expectations.
  • Verifies scientific logic and clarity of the document by verifying data in tables, listings, and figures against source documents, checking for consistency according to current regulatory standards and guidelines.
  • Edits for accuracy, consistency, and grammatical correctness.
  • Adjusts schedule to accommodate unexpected requests for priority review.
  • 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.

Education and Experience:
• Bachelor's degree or equivalent and relevant formal academic/vocational qualification required.
• 2+ Years of experience in reviewing CSR, Protocol, ICF, IB and other Regulatory Documents
• Experience working in the pharmaceutical/CRO industry preferred.
• Experience of direct formatting in Word for template compliance preferred.
• If CRO experience: experience working in a client-dedicated role or with 1 to 2 clients over multiple projects is preferred.

Knowledge, Skills, and Abilities:
• 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.
  
  What We Offer:
  At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.  
  As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel. 
  Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.