Medical Device, Medical Writer

Criterion Edge Professional Services Inc.; United States; Remote; USD 10,000 - 21,000; Part time

Job summary

Criterion Edge is seeking a remote Medical Writer to join our best-in-class writing team and help take our regulatory and scientific deliverables to new heights. You will produce a wide variety of reports, plans, and other documents for medical device, pharma/biotech, and in vitro device clients, collaborating with writers, project managers, and support staff.

This role emphasizes accuracy and regulatory alignment.

Qualifications

• 2+ years of direct writing experience in pharmaceutical, medical device, in vitro device or related academic fields.
• Minimum of a BSc in a life sciences or related discipline / related field.
• Advanced word processing skills, including Microsoft Office, Adobe Acrobat, Excel and SharePoint.
• Familiar with current guidelines and regulations governing the project.
• Knowledge of systematic literature review (SLR) methodology and best practices.
• High level of English fluency with strong oral and written communication.

Responsibilities

• Direct responsibility for writing documents or document sections on assigned projects.
• Organize workload, identify project needs and meet timelines.
• Meet client expectations through teamwork and adherence to deadlines.
• Collaborate effectively with other project writing team members.
• Document tasks, time estimates and due dates into the project plan and provide progress updates.
• Ensure data presented is clear, complete, accurate, and concise with consistent conclusions.
• Incorporate expert feedback and adjust content accordingly.
• Stay current with medical writing best practices and regulatory knowledge.
• Identify risks and discuss solutions with the project team.
• Participate in QC checks for accuracy following internal processes.
• Provide feedback to junior staff and mentors when appropriate.
• Establish professional relationships with colleagues and clients.
• Demonstrate initiative and seek clarity when faced with unfamiliar requirements.

Skills

Medical writing experience

English communication

Regulatory guidelines knowledge

Independent work

Education

BSc in Life Sciences

Tools

Microsoft Word

Adobe Acrobat

Excel

SharePoint

Job description

Criterion Edge is seeking a remote candidate for the role of Medical Writer to join our best-in‑class writing team and help take our customer focused writing services to new heights.

Employment Type and Location:

Remote 1099 Contractor (Part Time/Full Time) located in India

Job Overview

In the role of Medical Writer, you will have the opportunity to work closely with other writers, project managers and support specialists to produce a wide variety of regulatory and scientific reports, plans, and other written deliverables for medical device, pharma/biotech, and in vitro device clients.

The ideal candidate is a writing professional looking to build on their relevant medical writing experience, scientific knowledge, and well-developed written and oral communication skills. We value proactive thinkers with the ability and desire to work in a multifunctional team setting, producing documents and reports that align with the highest regulatory, scientific, and professional standards.

Roles and Responsibilities

• Direct responsibility for writing documents or document sections on assigned projects.
• Able to organize own project workload and tasks, identify project needs and adhere to project timelines.
• Understand client expectations and work to meet those expectations through teamwork, adherence to deadlines, problem-solving and scientific knowledge.
• Effectively collaborate with other members of the project writing team.
• Working with a Criterion Edge Project Manager, document your assigned tasks, time estimates and due dates into the Asana project plan. Provide weekly progress updates.
• Ensure all data presented in the document are clear, complete, accurate, and concise. Ensure all statements and conclusions are integrated, balanced, supported by appropriate data, and consistent across all related documents.
• Receive expert/scientific review comments and adjust the document content as required based on internal and external feedback.
• Stay abreast of current medical writing best practices and relevant regulatory knowledge.
• Proactively identify potential project risks and bring those forward to the overall project team to discuss and identify solutions.
• Participate in quality control (QC) checks for accuracy following established internal QC processes.
• Provide written and verbal feedback to junior staff and managers when appropriate.
• When requested, serve as a project mentor to assist in the training and development of junior staff on your project team(s).
• Establish and maintain effective, professional working relationships with co-workers, managers, and clients.
• Demonstrate initiative and sound judgement when faced with less familiar project requirements and/or document situations or challenges. Seeks understanding and additional clarity from Project Lead and/or Project Management before proceeding.

Qualifications and Skills

• 2+ years of direct writing experience in pharmaceutical, medical device, in vitro device or related academic fields.
• Minimum of a BSc in a life sciences or related discipline / related field.
• Advanced word processing skills, including Microsoft Office (including Word), Adobe Acrobat, Excel and collaborative document sharing platforms such as SharePoint; ability to learn and adapt to various IT systems.
• Familiar with all current and applicable guidelines and regulations governing the assigned project.
• Knowledge of and experience with systematic literature review (SLR) methodology and best practices, including Level 1 and Level 2 literature screening, data extraction and weighting and appraisal of data sets.
• High level of English fluency or native English speaker, with excellent oral (including presentation) and written communication, including grammatical/technical writing skills.
• Able to interact confidently with external stakeholders and communicate with others effectively and clearly.
• Capableof workingindependently to achieve assigned project goals with minimal supervision.
• Reliably produces high-quality written deliverables in accordance with customer and project requirements and agreed timelines.
• Excellent attention to detail and accuracy.
• Contributes, collaborates, shares responsibilities, and supports other team members to ensure success with tasks/projects.
• Demonstrates scientific rigor and understanding of the scientific process in written documents