Senior Medical Writer – Regulatory Submissions & Strategy

Artech Information System LLC; Peapack-Gladstone (NJ); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading staffing solutions firm in New Jersey is seeking a professional to create documents necessary for clinical data management and regulatory submissions. The ideal candidate will possess excellent scientific writing and analytical skills, managing deadlines and ensuring compliance with regulatory standards. You will lead document strategies and collaborate with project teams to deliver high-quality documents effectively. Strong interpersonal skills and familiarity with global regulatory guidance are essential for success in this role.

Qualifications

• Excellent scientific writing skills, with the ability to summarize and interpret complex data.
• Strong organizational skills and ability to manage deadlines.
• Proficiency with statistical concepts.

Responsibilities

• Manage document timelines and communicate resource needs.
• Ensure compliance with internal SOPs and regulatory guidance.
• Lead document strategy and collaborate with project teams.
• Deliver high-quality documents on time, managing any potential issues.
• Support teams with clinical data analyses and quality assurance.

Skills

Scientific writing skills

Analytic skills

Oral presentation skills

Strong organizational skills

Effective influencing and negotiating skills

Knowledge of global regulatory guidance

Functional fluency in spoken English

Tools

Word

PowerPoint

Excel

Job description

A leading staffing solutions firm in New Jersey is seeking a professional to create documents necessary for clinical data management and regulatory submissions. The ideal candidate will possess excellent scientific writing and analytical skills, managing deadlines and ensuring compliance with regulatory standards. You will lead document strategies and collaborate with project teams to deliver high-quality documents effectively. Strong interpersonal skills and familiarity with global regulatory guidance are essential for success in this role.