Medical Writer - GCP SOP

Mediabistro; Plano (TX); Remote; USD 40,000 - 80,000; Part time

Job summary

An established industry player is seeking a Contract Medical Writer for a part-time role focused on editing and quality control of clinical procedures. This fully remote position requires 8 years of relevant experience in the pharmaceutical or biotechnology sectors. The ideal candidate will have a strong background in developing and revising clinical SOPs while adhering to high-quality standards. This role offers a unique opportunity to contribute to clinical operations while enjoying the flexibility of remote work. Join a team that values quality and professionalism in clinical documentation.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Telehealth Services

Commuter Benefits

Qualifications

• 8 years of experience in developing and editing clinical SOPs.
• Experience with writing style guidelines in the pharmaceutical industry.

Responsibilities

• Edit and perform quality control reviews of clinical procedures.
• Develop and write new SOPs for the Clinical Operations team.

Skills

GxP SOPs Development

Clinical SOPs Editing

Writing Style Guidelines

Electronic Document Management

Pharmaceutical Industry Knowledge

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. This is a Part Time (up to 30 hours a week), 6 month contract role and is fully remote.

Responsibilities :

Edit and perform QC reviews of clinical procedures.Develop and write new SOPs for the Clinical Operations team.Work with Process Owners, SMEs, and stakeholders to develop and revise clinical procedures.Ensure that procedures, forms, and templates are written to a high-quality standard.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 SOPsPharmaceutical or Biotechnology experience requiredStart-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 encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit https : / / www.solomonpage.com / crn and connect with us on Facebook and LinkedIn.

Opportunity Awaits.

Create a job alert for this search