Medical Writer
Company: Aerotek
Location: Remote
Posted on: January 15, 2022
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Job Description:
Description:Under departmental supervision, the Medical Writer
will research, create, edit, and coordinate the production of
clinical documents associated with submissions to regulatory
authorities, including but not limited to: study protocols, model
informed consents, interim and final clinical study reports, and
safety update reports. The Medical Writer will also be responsible
for the production of clinical study documentation associated with
clinical trials that may not be included in a regulatory
submission.Medical writers primary responsibility is to communicate
complex medical information in clear and compliant writing. The
Medical Writer must ensure all deliverables are in accordance with
regulations, standards, and guidelines. The regulatory documents
that the Medical Writer prepares must meet ICH, GLPs, and GCPs
guidelines, a writing style guide, and company template. The
Medical Writer must understand the levels of evidence required to
achieve regulatory, clinical, operational, and marketing goals.
Essential Job Functions: Medical writer will be responsible for the
following: Partner with clinical teams to understand the nature of
the scientific work that they will be covering. Conduct
comprehensive literature searches to enhance their experience
understanding, then evaluate, analyze, and apply to clinical
documents. Compile, write, and edit medical writing deliverables
covering all phases of clinical research for submission to
regulatory agencies. Deliver clinical documents including
comprehensive clinical study reports, study protocols, annual
reports, investigator brochures, risk/benefit analysis and
integrated summaries from raw data. Manage assigned writing
projects. Attend meetings and support assigned therapeutic area
publication team in manuscript and/or publications submissions to
scientific meetings, medical journals. Manage document development
timelines to facilitate timely submission. Job Requirements:
Medical Writer must be aware of current industry practices and
regulatory requirements that affect medical writing. They must keep
abreast of current literature, emerging science, technological
developments, and medical trends. Ability to learn and recognize
how to best interpret, summarize, and present statistical and
medical information to ensure quality and accuracy of content in
document types under supervision. Leadership skills, both in time
management as well as in project/process management Able to resolve
basic problems independently and complex problems under
supervision. Familiarity with relevant publication, industry, and
regulatory document guidance and best practices Ability to build
solid and positive relationships with cross-functional team
members. Learning agility and attention to detail. Demonstrated
understanding of clinical research, the drug development process,
and industry guidelines and regulations, e.g., ICH-GCP. Extensive
clinical/scientific writing skills. Scientific essential; writing
experience includes multiple clinical study reports. Advanced word
processing skills, including MS Office (expertise in Word);
software and systems knowledge or ability to learn and adapt to
various IT systems: document management systems, collaborative
authoring (e.g., SharePoint), and file conversion and databases
(Excel). Willingness to work in a matrix environment, values the
importance of teamwork, and understands roles of other project team
members. Possesses team leadership skills and cross-cultural
sensitivity.Additional Skills & Qualifications:Experience /
Education Bachelors degree in life sciences; Masters, PhD, PharmD
desirable. Minimum of 3-5 years of experience in the pharmaceutical
or related industry, with relevant Oncology and/or Non-Oncology
(cardiovascular, respiratory and immunology) publication writing
experience specific to CSS, CSP, CSR, IP, and regulatory package
documentation. Fluent in written and spoken English with
appropriate attention to phraseology, grammar, and
punctuation.Experience Level:Intermediate LevelCompensation is tied
to the Colorado market for jobsperformed in Colorado.Other
locations may be subject to variances basedon locations-related
factors.We reserve the right to pay above or below the posted
wagebased on factors unrelated to sex, race, or any other protected
classification.Eligibility requirements apply to some benefits and
maydepend on your job classification and length of employment.
Benefits aresubject to change and may be subject to specific
elections, plan, or programterms.This temporary role may be
eligible for the following:
Keywords: Aerotek, Eugene , Medical Writer, Advertising , Remote, Oregon
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