Medical Writing Publisher

Bengaluru - India

Monthly Salary: Not Disclosed

Posted on: 14 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Overview:

Responsible for Medical Writing activities such as appendices collation peer review and QC and publishing for designated projects and to ensure quality and compliance with Fortrea or Sponsors SOPs ICH GCP and regulatory requirements.

Summary of Responsibilities:

Assist with preparation of study related documents e.g. Study Protocols Clinical Study Reports Patient Narratives etc.
Prepare the Clinical Study Report Appendices (ICH E3 Section 16).
Assist with the publishing of documents within the Medical Writing Department and other departments as agreed with Medical Writing Management.
Review timelines and ensure that Medical Writers/Project Manager/Client are informed of status.
Assist with the review and QC process for documents within Medical Writing.
Ensure that work is in compliance with the relevant regulatory guidelines.
With guidance from line management and experienced staff set priorities for preparatory tasks and ensure deadlines are maintained.
And all other duties as needed or assigned.

Qualifications (Minimum Required):

Bachelors degree in a biomedical life sciences or related discipline.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

Minimum 2 to 3 years of experience or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
Prior experience as a Publisher within a Medical Writing or clinical department for national or multinational studies.

Physical Demands/Work Environment:

Home based environment.
Must be able to see (distinguish colors) and hear to meet if necessary the job requirements.
Must have excellent command of the English language both oral and written.
Must be able to use hands to finger handle or touch objects tools or controls including a computer keyboard for up to 6-8 hours.
Regularly required to sit.

Learn more about our EEO & Accommodations request here.

Job Overview:Responsible for Medical Writing activities such as appendices collation peer review and QC and publishing for designated projects and to ensure quality and compliance with Fortrea or Sponsors SOPs ICH GCP and regulatory requirements.Summary of Responsibilities:Assist with preparation of...