Lead Medical Writer - Remote Regulatory & Publications

Veristat, LLC.; Massachusetts; On-site; USD 132,000 - 151,000; Full time

Benefits offered by this job

Remote working

Flexible time off

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Job summary

Veristat, LLC. seeks a Principal Medical Writer with a MedPubs focus to independently plan and prepare regulatory documents for all product-development stages.

You will organize, analyze, and present scientific data per ICH and other guidelines, collaborating with cross-functional teams. The role requires a strong publication background, leadership of multiple manuscripts and abstracts, and advanced knowledge of publication standards.

Qualifications

• Bachelor’s degree required; PhD, MD or PharmD preferred; science-related field preferred.
• Minimum of 7 years of medical writing experience in a CRO or pharma/biotech setting.
• Lead writer on at least 20 manuscripts, abstracts, posters or oral presentations across all phases.
• Advanced knowledge of ICH and related guidelines; CMPP certification preferred.

Responsibilities

• Plan and prepare regulatory documents and medical communications for product development.
• Organize, analyze, interpret, and present scientific and statistical information per guidelines.
• Collaborate with cross-functional internal and external document teams and management.

Skills

MS Office

Adobe Acrobat

Strong writing

Oral communication

Education

Bachelor's degree

PhD/MD/PharmD preferred

Tools

ISMPP CMPP

Job description

Veristat, LLC. seeks a Principal Medical Writer with a MedPubs focus to independently plan and prepare regulatory documents for all product-development stages.

You will organize, analyze, and present scientific data per ICH and other guidelines, collaborating with cross-functional teams. The role requires a strong publication background, leadership of multiple manuscripts and abstracts, and advanced knowledge of publication standards.