At Thermo Fisher Scientific, you’ll 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.
Discover Impactful Work:
We are looking for a Senior Document Review Specialist to join our FSP Medical Writing team. This role would be dedicated to one client and fully remote, working from certain EMEA locations. As a Senior Document Review Specialist, you will review documents to ensure quality of a standard that meets or exceeds client's expectations. Documents include: regulatory submissions, integrated clinical study reports, serious adverse event narratives, study protocols and publications. You will be ensuring integrity of data in tables against source documents, instructing others outside of the quality review group on the review process.
A Day in the Life:
* Reviews highly technical documents of all types to ensure a quality standard that meets or exceeds client expectations.
* Ensures scientific logic and clarity of the document by verifying data in tables 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.
* Coordinates the work of team members and tracks the status of documents being reviewed.
* Mentors junior team members.
* May represent the department at meetings with clients.
* Contributes to the development and modification of the quality review process.
* Collaborates with the writer to manage alliance account(s).
* Delegates weekly assignments to the quality review team and fields questions as appropriate.
Keys to Success:
* Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
* Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
* Capable of concentrating on the details of a document without losing sight of the overall objectives and intent of the document's message.
* Thorough knowledge of medical terminology, statistical concepts, GCP, guidelines (ICH), and requirements of the FDA and other international regulatory agencies.
* Familiarity with interpreting data and excellent analytical ability.
* Effective oral and written communication skills.
* Good organizational and planning skills.
* Good interpersonal skills.
* Ability to work on own initiative.
* Good computer literacy and expertise.
* Solid understanding of document management systems.
* Suitable level of expertise within a broad range of medical writing projects.
* Good knowledge of global and regional medical writing and regulatory affairs duties for clinical trials, marketing authorization and late-phase procedures.
* Capable of providing general advice and training to others.
* 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.
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
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.
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