Medical Writer - GCP SOP

Mediabistro; Littleton (CO); On-site; USD 70,000 - 110,000; Full time

Job summary

An innovative firm is seeking a skilled Medical Writer to ensure high-quality clinical procedures and documents. With a focus on editing and quality control, this role involves developing new SOPs and collaborating with various stakeholders to uphold writing standards. The ideal candidate will have extensive experience in the pharmaceutical or biotechnology sectors, particularly in developing GxP SOPs. This position offers a unique opportunity to contribute to the clinical operations of a forward-thinking organization, providing essential support in the drug development process.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Telehealth Services

Employee Stock Ownership Plan (ESOP)

Commuter Benefits

Qualifications

• 8+ years of experience in developing and editing GxP and Clinical SOPs.
• Proven experience in applying writing style guidelines and standards.

Responsibilities

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

Skills

GxP SOPs Development

Clinical SOPs Editing

Writing Style Guidelines

Clinical Development Knowledge

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 :

1. 8 years of relevant experience developing and editing GxP SOPs and Clinical SOPs.
2. Pharmaceutical or Biotechnology experience required.
3. Start-up experience is ideal.
4. Experience in applying writing style guidelines and standards.
5. Experience across multiple disciplines within clinical development in the pharmaceutical industry, with knowledge of the drug development process.
6. Proven experience in developing, maintaining, and using electronic templates.
7. 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.