Senior Medical Writer
Company: Joul--
Location: Armonk
Posted on: May 22, 2025
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Job Description:
Title: Senior Medical Writer
Experience, qualification, and soft skills, have you got everything
required to succeed in this opportunity Find out below.
Location: Armonk, NY (hybrid)
Duration: 9 month contract, possible to renew
Pay range: $65-75/HR
Start Date: ASAP
The Senior Medical Writer (SMW) works with team members and
independently to write the content of clinical documents that may
include CSRs, protocols, ICFs, narratives and IBs in a variety of
therapeutic areas. Opportunities to contribute to other regulatory
documents may be provided. The SMW tracks his/her own writing
projects and is responsible for adhering to regulatory guidelines
and department document standards. The SMW may also serve as lead
for a compound and may also review the work of junior/outsourced
writers as well as review CSR-related documents (Statistical
Analysis Plans, TFLs) to help ensure appropriate content for
inclusion.
In this role, a typical day might include the following: Works with
the clinical team, to write the content of clinical documents that
may include CSRs, protocols, ICFs, narratives and IBs in a variety
of therapeutic areas. Opportunities to write or contribute to other
Regulatory documents may be provided
Represents MW at meeting and drives document development
meetings
Participates in process improvement initiatives, working groups,
etc. within MW and throughout Global Development
Manages processes and organizes priorities; solves problems;
fosters collaboration to resolves conflict
May review the work of junior and outsourced MWs
May review CSR-related documents (Statistical Analysis Plans, TFLs)
to help ensure appropriate content for inclusion
Writes in plain language style as appropriate (eg, for ICF),
explains complex medical/scientific concepts (such as medical
procedures, clinical study design, and drug mechanisms) to a lay or
patient audience
This job might be for you if you have: Strong knowledge of the
clinical research process and regulations/guidelines
Clinical document reading, writing, and editing experience
Strong organizational, interpersonal and communication skills
Strong knowledge of MS WORD, Adobe Acrobat, PowerPoint, and
electronic document management systems
Ability to manage multiple projects
Familiarity with ICH GCP guidelines
To be considered for this role, you must have Bachelor's degree
(advanced degree preferred) and minimum of 3 years of relevant MW
experience including working knowledge of biostatistics.
System One, and its subsidiaries including Joul--, ALTA IT
Services, and Mountain Ltd., are leaders in delivering outsourced
services and workforce solutions across North America. We help
clients get work done more efficiently and economically, without
compromising quality. System One not only serves as a valued
partner for our clients, but we offer eligible employees health and
welfare benefits coverage options including medical, dental,
vision, spending accounts, life insurance, voluntary plans, as well
as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified
applicants will receive consideration for employment without regard
to race, color, religion, sex (including pregnancy, childbirth, or
related medical conditions), sexual orientation, gender identity,
age, national origin, disability, family care or medical leave
status, genetic information, veteran status, marital status, or any
other characteristic protected by applicable federal, state, or
local law.
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Ref: #568-Clinical
Keywords: Joul--, Paterson , Senior Medical Writer, Healthcare , Armonk, New Jersey
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