Medical Writer: Regulatory Submissions & CSRs

Artech Information System LLC; Pennington (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

A global staffing and IT consulting company is seeking a Medical Writer to coordinate and author documents for regulatory submissions. The ideal candidate should have a PhD/MD/PharmD in a relevant scientific discipline or equivalent experience in pharmaceutical regulatory documentation. Strong writing skills, organizational abilities, and experience working in cross-functional teams are essential. This role involves participating in document strategy sessions and ensuring high-quality deliverables within set timelines.

Qualifications

• PhD/MD/PharmD in scientific discipline or MS/BS with relevant experience.
• Strong writing skills for regulatory documentation and publications.
• Ability to manage timelines and quality of work in cross-functional teams.

Responsibilities

• Coordinate and author documents for regulatory submissions.
• Participate in document strategy sessions and manage timelines.
• Review and edit documents, ensuring high quality.

Skills

Strong writing skills

Organization skills

Communication skills

Interpersonal skills

Education

PhD/MD/PharmD in a relevant scientific discipline

MS / BS with a minimum of 3 to 5 years in pharmaceutical regulatory documentation

Tools

Document management system

Job description

A global staffing and IT consulting company is seeking a Medical Writer to coordinate and author documents for regulatory submissions. The ideal candidate should have a PhD/MD/PharmD in a relevant scientific discipline or equivalent experience in pharmaceutical regulatory documentation. Strong writing skills, organizational abilities, and experience working in cross-functional teams are essential. This role involves participating in document strategy sessions and ensuring high-quality deliverables within set timelines.