Medical Writer - GCP SOP

Clinical Resource Network (CRN); Chicago (IL); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a skilled Medical Writer to join their dynamic team in Chicago. This role focuses on editing and quality control of clinical procedures, ensuring adherence to high-quality standards and company guidelines. With over 8 years of experience in the pharmaceutical or biotechnology sectors, the ideal candidate will develop and revise SOPs while collaborating with various stakeholders. This innovative firm offers a comprehensive benefits program, including medical, dental, and 401(k) plans, making it an attractive opportunity for professionals looking to make a significant impact in clinical research.

Benefits

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Telehealth services

Commuter benefits

Qualifications

• 8+ years of experience in developing and editing GxP and Clinical SOPs.
• Proven experience with electronic document management systems.

Responsibilities

• Edit and perform QC reviews of clinical procedures.
• Develop and write new SOPs for the Clinical Operations team.
• Ensure high-quality standards in clinical documentation.

Skills

GxP SOPs

Clinical SOPs

Pharmaceutical experience

Biotechnology experience

Writing style guidelines

Electronic document management

Tools

Electronic templates

Document management systems

Job description

Our client is looking to fill the role of Medical Writer. The Contract Medical Writer is responsible for editing and performing quality control (QC) reviews of clinical procedures. This role will develop and revise clinical procedures. The Writer ensures that procedures, forms, and templates adhere to high-quality standards and the company's writing style guide, as well as standards for clinical procedures/documents.

Responsibilities :

1. Edit and perform QC reviews of clinical procedures.
2. Develop and write new SOPs for the Clinical Operations team.
3. Work with Process Owners, SMEs, and stakeholders to develop and revise clinical procedures.
4. Ensure that procedures, forms, and templates are written to a high-quality standard.
5. Adhere to the company’s writing style guide and standards for clinical procedures/documents.

Qualifications :

• 8 years of relevant experience developing and editing GxP SOPs and Clinical SOPs.
• Pharmaceutical or Biotechnology experience required.
• Start-up experience is ideal.
• Experience in applying writing style guidelines and standards.
• Experience across multiple disciplines within clinical development in the pharmaceutical industry, with knowledge of the drug development process.
• Proven experience in developing, maintaining, and using electronic templates.
• Experience working in an electronic document management system.

If you meet the required qualifications and are interested in this role, please apply today.

Clinical Resource Network Distinction

CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants — which sets us apart in the industries we serve.

About CRN

Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services include contract staffing, project staffing, consultative services, and full-time placements. For more information, visit our website and connect with us on Facebook and LinkedIn.

Opportunity awaits.