Remote Principal Medical Writer – CMC Focus

Veristat; Massachusetts; Hybrid; USD 132,000 - 151,000; Full time

Benefits offered by this job

Remote working

Flexible time off

Medical insurance

Tuition reimbursement

Retirement plans

Job summary

Veristat is seeking a Principal Medical Writer with CMC focus for remote work. You will lead authoring for complex regulatory submissions, mentor junior writers, and drive document quality across modules, including Module 3 and 2.3, ensuring alignment with global health authority expectations.

You should have 7+ years of regulatory writing experience, a science degree, and strong leadership skills to manage timelines and client needs in a fully remote, collaborative environment.

Qualifications

• Bachelor's degree or higher, scientific discipline strongly preferred.
• 7+ years of regulatory writing experience.
• Experience with NDAs, INDs, BLAs, or IMPDs.
• Lead authoring for Modules 3 and 2.3 in submissions.

Responsibilities

• Lead authoring for Modules 3 and 2.3 in regulatory submissions.
• Mentor team members on regulatory writing practices.
• Collaborate with cross-functional teams to ensure compliant documents.

Skills

Regulatory writing

Project leadership

Mentoring teammates

Microsoft Word & docs

Communication skills

Time management

Submissions knowledge

Education

Bachelor’s degree or higher (science)

Tools

MS Word

Job description

Veristat is seeking a Principal Medical Writer with CMC focus for remote work. You will lead authoring for complex regulatory submissions, mentor junior writers, and drive document quality across modules, including Module 3 and 2.3, ensuring alignment with global health authority expectations.

You should have 7+ years of regulatory writing experience, a science degree, and strong leadership skills to manage timelines and client needs in a fully remote, collaborative environment.