Senior Medical Writer, Clinical Focus — Remote

Veristat; Massachusetts; Hybrid; 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 is seeking a Senior Medical Writer - Clinical Focus to lead document authorship across service lines and serve as project lead on smaller engagements while supporting larger teams. The role involves interfacing directly with clients to ensure high-quality regulatory submissions for health authority review.

Minimum 3+ years in regulatory writing, with experience in CSRs, Investigator Brochures, protocols, ISS/ISE, and related clinical documents.

Qualifications

• Bachelor’s degree or higher in a scientific discipline strongly preferred.
• 3+ years of regulatory writing experience or equivalent experience with clinical related documentation.
• Understand regulatory authority guidelines and requirements to lead internal project teams.
• Experience in development of submission-level documents (not necessarily as document lead).
• Experience in development of clinical documents such as CSRs, Investigator Brochures, protocols, ISS, and/or ISE.

Responsibilities

• Lead, as project lead on smaller projects, interfacing with clients and supporting larger engagements.
• Contribute to document authorship across service lines and ensure quality.
• Support teams to help clients achieve regulatory approval/acceptance.

Skills

Regulatory writing

Clinical Study Reports

Investigator Brochures

Protocols

ISS/ISE

CRM leadership

Microsoft Word

Education

Bachelor’s degree in a scientific discipline

Tools

Microsoft Word

Job description

Veristat is seeking a Senior Medical Writer - Clinical Focus to lead document authorship across service lines and serve as project lead on smaller engagements while supporting larger teams. The role involves interfacing directly with clients to ensure high-quality regulatory submissions for health authority review.

Minimum 3+ years in regulatory writing, with experience in CSRs, Investigator Brochures, protocols, ISS/ISE, and related clinical documents.