Sr Document Review Spec - West Coast Based
Thermo Fisher Scientific
Nơi làm việc
Seattle, WA, USA
Chi tiết công việc
Summarized Purpose:
Effectively reviews documents created within or outside of the company 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. Ensures integrity of data in tables against source documents. Instructs others outside of the quality review group on the review process. This role will be embedded within a client dedicated team. You will work alongside the clients own experienced personnel, as well as PPD Clinical Research Services colleagues to deliver leading edge clinical support.
• Reviews highly technical documents of all types created within or outside of the company to ensure quality standard that meets or exceeds client's 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 manager alliance account(s)
• Delegates weekly assignments to the quality review team and fields questions as appropriate
Education and Experience:
• 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’).
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
• 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 (e.g. 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
• Competent word processing skills
• 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
General Remote Based
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)
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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status
