Senior Medical Writer - Regulatory Lead (Remote)

Synchrogenix Information Strategies, LLC; Massachusetts; On-site; USD 132,000 - 151,000; Full time

Benefits offered by this job

Remote work option

Flexible time off

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Job summary

Veristat is seeking a Principal Medical Writer to independently plan and prepare regulatory documents and medical communications across product development stages. You will coordinate with cross‑functional teams to ensure compliance with ICH, ICMJE, and GPP guidelines and company standards.

The role requires a Bachelor’s degree, seven years of medical writing experience, and lead authorship on 20+ manuscripts. Remote work is available; compensation includes a salary range and bonus potential.

Qualifications

• Bachelor’s degree required; advanced degrees preferred (PhD/MD/PharmD).
• Minimum seven years of medical writing experience in CRO or pharma/biotech.
• Lead writer on 20+ manuscripts, abstracts, posters, or oral presentations.
• ISMPP or CMPP certification preferred.

Responsibilities

• Plan, write, and edit regulatory documents and medical communications across product development.
• Organize, analyze, and present scientific and statistical data per guidelines and standards.
• Collaborate with stakeholders to meet regulatory and client requirements.
• Maintain up-to-date knowledge of regulatory/publication guidelines for consistency and quality.

Skills

MS Office Suite

Adobe Acrobat

Strong written/oral communication

Regulatory guidelines knowledge

Leadership/writing oversight

Education

Bachelor's degree

PhD/MD/PharmD preferred

Job description

Veristat is seeking a Principal Medical Writer to independently plan and prepare regulatory documents and medical communications across product development stages. You will coordinate with cross‑functional teams to ensure compliance with ICH, ICMJE, and GPP guidelines and company standards.

The role requires a Bachelor’s degree, seven years of medical writing experience, and lead authorship on 20+ manuscripts. Remote work is available; compensation includes a salary range and bonus potential.