Senior Medical Writer - Clinical Lead (Remote)

Veristat; Massachusetts; On-site; USD 116,000 - 128,000; Full time

Benefits offered by this job

Remote working

Flexible time off

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Job summary

Veristat, a global clinical research company, is seeking a Senior Medical Writer with a clinical focus to lead document authorship across service lines. The role interfaces with clients and serves as project lead on smaller engagements within a larger delivery team.

The qualified candidate will apply expertise in regulatory writing to support Clinical Study Reports, Investigator Brochures, protocols, ISS, and/or ISE, contributing to successful health authority submissions while collaborating

Qualifications

• 3+ years of regulatory writing experience or equivalent experience with clinical related documentation
• Understand regulatory authority guidelines and requirements to lead an internal project team and anticipate effects on the final product during health authority approvals
• Experience in the development of submission-level documents (does not require functioning as a document lead)
• Experience in developing clinical documents such as Clinical Study Reports, Investigator Brochures, protocols, ISS, and/or ISE

Education

Bachelor’s degree or higher in a scientific discipline

Tools

Microsoft Word

Job description

Veristat, a global clinical research company, is seeking a Senior Medical Writer with a clinical focus to lead document authorship across service lines. The role interfaces with clients and serves as project lead on smaller engagements within a larger delivery team.

The qualified candidate will apply expertise in regulatory writing to support Clinical Study Reports, Investigator Brochures, protocols, ISS, and/or ISE, contributing to successful health authority submissions while collaborating