Medical Writer
The ideal candidate will take on the following tasks:
Write, edit, review and format documents to conform with regulatory submissions and internal standards.
Provide medical writing support for the preparation of manuscripts, abstracts, posters and review articles.
Participate in document QC process.
As a lead writer, plan and manage the documentation process, project timelines, and resource requirements on large medical writing projects.
Supervise CRO medical writers.
Format text, tables and graphs in regulatory documents to meet standards for electronic regulatory submissions.
Attends meetings re: documents in development (e.g., clinical study report team meetings), and provides attendees with document status reports.
The ideal candidate will possess the following qualities:
Advanced degree in life sciences and 8
years of medical writing and editing experience in the biotech, pharma or medical device industry.
Experience writing, editing, reviewing and formatting clinical regulatory documents (e.g. clinical study protocols, clinical study reports, investigator brochures and sections of INDs, NDAs and/or BLAs).
Thorough knowledge of ICH Guidelines associated with regulatory submissions (BLAs and/or NDAs, INDs), and other regulatory documents (CSRs, IBs and clinical study protocols).
Knowledge of bio statistical and clinical research concepts.
Strong understanding of the drug, biologic, and/or medical device product development process.Estimated Salary: $20 to $28 per hour based on qualifications.
Write, edit, review and format documents to conform with regulatory submissions and internal standards.
Provide medical writing support for the preparation of manuscripts, abstracts, posters and review articles.
Participate in document QC process.
As a lead writer, plan and manage the documentation process, project timelines, and resource requirements on large medical writing projects.
Supervise CRO medical writers.
Format text, tables and graphs in regulatory documents to meet standards for electronic regulatory submissions.
Attends meetings re: documents in development (e.g., clinical study report team meetings), and provides attendees with document status reports.
The ideal candidate will possess the following qualities:
Advanced degree in life sciences and 8
years of medical writing and editing experience in the biotech, pharma or medical device industry.
Experience writing, editing, reviewing and formatting clinical regulatory documents (e.g. clinical study protocols, clinical study reports, investigator brochures and sections of INDs, NDAs and/or BLAs).
Thorough knowledge of ICH Guidelines associated with regulatory submissions (BLAs and/or NDAs, INDs), and other regulatory documents (CSRs, IBs and clinical study protocols).
Knowledge of bio statistical and clinical research concepts.
Strong understanding of the drug, biologic, and/or medical device product development process.Estimated Salary: $20 to $28 per hour based on qualifications.
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