Clinical SOP Writer

Lancesoft; Nutley (NJ); Hybrid; USD 60,000 - 90,000; Part time

Job summary

Lancesoft in Nutley, NJ seeks a Clinical SOP Writer to develop new and revise existing procedures in a remote or hybrid setting. You will collaborate with Process Owners, SMEs, and stakeholders to ensure procedures meet high-quality standards and regulatory requirements.

Ideal candidates have a Bachelor's degree in English or science with writing experience, strong MS Word/Excel skills, and proven editing, QC, and communication abilities along with solid project management skills.

Qualifications

• Bachelor's degree in English or related subject, or science with writing experience.
• Proven writing, editing, and quality control review experience.
• Proficiency in MS Word and Excel, applying writing style guidelines and standards.
• Experience with clinical development and regulatory requirements (ICH/GCP).
• Strong communication and project management skills.

Responsibilities

• Develop new and revise existing clinical procedures, forms, and templates.
• QC review of clinical procedures.

Skills

Writing & Editing

Quality Control

MS Word

MS Excel

Regulatory Knowledge

Project Management

Communication Skills

Education

Bachelor's degree in English or related subject

Bachelor's degree in science with writing experience

Tools

MS Office Suite

Job description

Clinical SOP Writer Remote or Hybrid PART/FULL TIME 20-40 HOURS A WEEK

The Clinical SOP Writer works with Process Owners, Subject Matter Experts (SMEs), and relevant stakeholders to develop new and revise existing clinical procedures. The Writer ensures procedures and associated forms and templates are written to a high-quality standard and according to writing style guide and to standards for clinical procedures/documents. The Clinical SOP Writer may also perform QC review of clinical procedures.

Requirements

• Bachelor s degree in English or related subject, or Bachelor s degree in science with proven writing experience
• Proven writing, editing, and quality control review experience.
• Proficiency in MS Word and Excel, experience in applying writing style guidelines and standards
• Experience of working with multiple disciplines in clinical development in the pharmaceutical industry, with knowledge of the drug development process.
• A working knowledge of compliance standards, and ICH, GCP, and regulatory requirements
• Customer-focused approach, with strong project management, multitasking, and interpersonal skills.
• Excellent communication skills both oral and written at all levels