Medical Writer - GCP SOP

Clinical Resource Network (CRN); San Francisco (CA); Remote; USD 200,000 - 250,000; Part time

Job summary

An established industry player is seeking a talented Medical Writer to join their team. This role involves editing and quality control of clinical procedures, ensuring adherence to high standards and company guidelines. As a part-time, fully remote position, you will have the flexibility to contribute to the development of critical clinical documentation. With a focus on quality and precision, this opportunity allows you to leverage your extensive experience in the pharmaceutical sector while working within a supportive and innovative environment. If you are passionate about making a difference in clinical research, this role is for you.

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.
• Experience in applying writing style guidelines and standards.
• Proven experience in using electronic templates.

Responsibilities

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

Skills

GxP SOPs Development

Editing Skills

Clinical SOPs Knowledge

Pharmaceutical Industry Knowledge

Electronic Document Management

Tools

Electronic Document Management System

Job description

Direct message the job poster from Clinical Resource Network (CRN)

Leader in Pharmaceutical Talent Acquisition

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 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 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.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Contract

Job function

• Job function

  Science

• Industries

  Pharmaceutical Manufacturing

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