CER Medical Writer

Overview

Job Details

• Job Type: Full-time

• Employment Type and Location: Remote 1099 Contractor (Part-Time/Full-Time) located in India

Job Overview

Criterion Edge is seeking a Medical Writer to join our best-in-class writing team and deliver customer-focused writing services. In this role, you will work closely with other writers, project managers, and support specialists to produce regulatory and scientific reports for medical device, pharma/biotech, and in vitro device clients.

We are looking for a professional with medical writing experience, scientific knowledge, and excellent communication skills who thrives in a collaborative environment and produces high-quality deliverables.

Roles and Responsibilities

As a member of our project writing team, you will be responsible for producing high-quality regulatory and scientific documents. Your key responsibilities include:

Document Creation & Management

• Write and deliver assigned documents and report sections with accuracy and clarity.

• Ensure all data is clear, accurate, concise, and consistent across documents.

• Incorporate expert/scientific review comments and revise documents as required.

• Participate in quality control (QC) checks following established processes.

Project Collaboration & Communication

• Collaborate effectively with other writers and project managers to meet client needs.

• Document tasks, time estimates, and deadlines using Asana and provide weekly updates.

• Communicate clearly with external stakeholders and adapt based on client feedback.

Process Improvement & Mentorship

• Stay updated with best practices and regulatory guidelines in medical writing.

• Identify potential project risks and work with the team to find solutions.

• Mentor junior staff and provide written and verbal feedback when needed.

Qualifications and Skills

• Experience:

  • Minimum 2+ years of direct writing experience in pharmaceutical, medical device, in vitro device, or related fields.

• Education:

  • BSc degree in life sciences or a related discipline.

• Technical Skills:

  • Advanced proficiency in Microsoft Office (Word, Excel), Adobe Acrobat, and collaborative tools like SharePoint.

  • Familiarity with systematic literature review (SLR) methodology, including data screening, extraction, and analysis.

• Language & Communication:

  • High-level English fluency (or native speaker) with excellent oral and written communication skills.

  • Ability to interact confidently with external stakeholders.

• Personal Attributes:

  • Capable of working independently with minimal supervision.

  • Demonstrates scientific rigor and attention to detail in all deliverables.

  • Collaborative mindset with a proactive approach to solving challenges.

Would you like any additional customization or adjustments?