Sr Document Review Spec - West Coast Based
Company: Thermo Fisher Scientific
Location: Seattle
Posted on: January 27, 2023
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Job Description:
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.+
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 appropriateEducation 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 environmentGeneral 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.)\#LI-CE1Thermo 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.
Keywords: Thermo Fisher Scientific, Seattle , Sr Document Review Spec - West Coast Based, Other , Seattle, Washington
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