Sr. Medical Writer (100 % REMOTE)
Company: Thrive
Location: Seattle
Posted on: May 16, 2022
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Job Description:
A Biotechnology sponsor company is looking for a Sr. Medical
Writer
Rates are very flexible
Overview
You will be responsible for creating, authoring, and leading the
management of key documents for programs, regulatory filings,
clinical studies and external publications, such as clinical
protocols (and amendments), clinical study reports, subject consent
forms, investigator's brochures, product dossiers, integrated
safety and efficacy summaries, and other documents required for
regulatory submissions, abstracts, posters and manuscripts.
In this position, you will collaborate with and actively
participate in cross-functional teams including representatives
from clinical operations, data sciences, regulatory affairs,
medical, biostatistics, pharmacovigilance/safety, new product
planning, program management, and corporate communications. In
addition, you may partner with Key Opinion Leaders (KOLs), Contract
Research Organizations (CROs), and co-development partners.
Responsibilities:
--- Coordinate development of, and serve as principal writer for,
clinical protocols/amendments, clinical study reports, investigator
brochures, Module 2 summaries and other elements of regulatory
submissions
--- Organize and lead document development and review meetings
--- Develop and ensure adherence to clinical and regulatory writing
timelines, standards and processes
--- Critically review statistical analysis plans to ensure
alignment with anticipated data presentations in clinical study
reports and Module 2 summaries
--- Perform literature-based research to support writing
activities
--- Lead medical writing and cross-functional initiatives
pertaining to document standards, template development, and
processes
Qualifications:
--- At least 6 years of clinical/regulatory medical writing
experience in the pharmaceutical or biotech industry
--- An understanding of the drug development process including
clinical study conduct, data collection and analysis, and
interactions essential to regulatory submissions
--- Knowledge of ICH guidelines, GxP, and relevant regulatory
requirements
--- Demonstrated understanding of standard clinical document types
(i.e., protocol, investigator's brochure, clinical study reports,
etc.) and experience as a lead author with such documents
--- A Bachelors, Masters, PharmD or Ph.D. in a life science or
health discipline
Keywords: Thrive, Seattle , Sr. Medical Writer (100 % REMOTE), Healthcare , Seattle, Washington
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