Senior Medical Writer, Regulatory & Clinical Documentation

PepGen; Boston (MA); Remote; USD 80,000 - 100,000; Full time

Job summary

A clinical-stage biotechnology company is seeking a Medical Writer to lead the development of regulatory and clinical documents. The role requires expertise in medical writing and collaboration with various teams to ensure high-quality documentation. Candidates should have a minimum Bachelor's degree, ideally a PhD, with at least 5 years of experience in regulatory medical writing. The position is based in Boston, offering a dynamic team environment focused on innovative therapy development.

Qualifications

• 5+ years of regulatory medical writing experience.
• Outstanding written and verbal communication skills.
• Well-organized with knowledge of biostatistics and regulatory environment.

Responsibilities

• Lead development of regulatory and clinical documents.
• Manage clinical/regulatory document preparation collaboratively.
• Develop medical writing departmental processes and procedures.

Skills

Medical writing

Communication skills

Collaboration skills

Knowledge of drug development

Education

Bachelor’s degree or PhD in Life Science

Job description

A clinical-stage biotechnology company is seeking a Medical Writer to lead the development of regulatory and clinical documents. The role requires expertise in medical writing and collaboration with various teams to ensure high-quality documentation. Candidates should have a minimum Bachelor's degree, ideally a PhD, with at least 5 years of experience in regulatory medical writing. The position is based in Boston, offering a dynamic team environment focused on innovative therapy development.