ID
#8390456
Job type
Contract
Salary
Depends on Experience
Source
Softova Inc
Date
2021-01-14
Deadline
2021-03-15

Sr. Medical Writer

Massachusetts, Cambridge, 02138

Contract

Vacancy expired!

Job Title: Sr. Medical Writer

Location: Cambridge, MA

RESPONSIBILITIES:Draft, edit, format, and finalize clinical regulatory documents including, but not limited to: clinical protocols and amendments, investigator's brochures (IBs), and clinical study reports (CSRs).Provide quality control (QC) review of clinical regulatory documents, as appropriate.Produce high quality and on-time writing deliverables to support the activities and goals of the clinical study team(s), clinical program, and the Medical Writing function.Ensure a consistent style of presentation of clinical documents to maintain quality and ease of review, and adherence to company standards.Facilitate efficient review and finalization process of documents produced internally and externally by contractors and vendors.Assist in the development of templates and standard operating procedures (SOPs).Represent Medical Writing on one or more program teamsParticipate in Medical Writing initiatives, and process improvement, as appropriateOncology experience preferredBachelor's degree in a relevant scientific field is required; advanced degree preferred.Skills:A minimum of 5 years medical writing experience in the biopharmaceutical industry with in-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines and the drug development process.Strong written and verbal communication skills, including fluency in oral and written English with the ability to clearly present clinical data.Regulatory submissions and knowledge of eCTD formatting preferred.

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