Senior Medical Writer - Remote Regulatory Submissions

SimulStat Inc.; Summit (NJ); Remote; USD 110,000 - 150,000; Full time

Job summary

SimulStat Inc. seeks a Sr. Medical Writer to support the development of global regulatory documentation strategy and the execution of tactics.

You will conceptualize and develop medical communications for reviewer-friendly clinical documents to support regulatory agency review, coordinating progress against global regulatory plans. The role requires a strong background in medical writing, regulatory submissions, and project management, with 6–8 years of industry experience and advanced degrees

Qualifications

• Minimum 6–8 years of medical writing experience.
• Experience managing regulatory submissions desirable.
• Knowledge of drug development and regulatory requirements.

Responsibilities

• Develop and contribute to global regulatory documentation strategy and execution.
• Coordinate writing and reviews of regulatory submission documents.
• Adhere to SOPs and guidelines governing regulatory documents and submissions to health authorities.
• Establish target dates and communicate timelines to management.

Skills

Medical writing

Regulatory knowledge

Project management

Analytical skills

Team collaboration

Regulatory submissions

Computer skills

Education

Bachelor's degree in life sciences

MS/PhD desirable

Tools

MS Office

Job description

SimulStat Inc. seeks a Sr. Medical Writer to support the development of global regulatory documentation strategy and the execution of tactics.

You will conceptualize and develop medical communications for reviewer-friendly clinical documents to support regulatory agency review, coordinating progress against global regulatory plans. The role requires a strong background in medical writing, regulatory submissions, and project management, with 6–8 years of industry experience and advanced degrees