Associate Medical Writer, In Vitro Diagnostic Regulation (IVDR) Writing Services

Criterion Edge; Remote; MYR 203,000 - 286,000; Full time

Job summary

A leading healthcare writing company is seeking an experienced Associate Medical Writer to manage and write regulatory-compliant performance evaluation reports. This position involves collaborating with project teams and maintaining high-quality standards while meeting project deadlines. The ideal candidate should have previous experience in regulatory writing, strong communication skills, and a background in science or medicine. This is a full-time remote position based in Batu Pahat, Malaysia, with opportunities to grow your medical writing career.

Qualifications

• Previous experience writing CERs and/or PERs according to EU regulations.
• Strong command of medical and laboratory terminology.
• Scientific/research background with understanding of research design.

Responsibilities

• Take direction from project writing team on tasks.
• Plan workload and adhere to project timelines.
• Monitor work for accuracy and quality.
• Work with Project Manager to document tasks accurately.
• Maintain effective working relationships with co-workers and clients.

Skills

Ability to produce regulatory-compliant documents

Well-developed written and oral communication skills

Proactive problem-solving

Attention to detail

Teamwork

Education

Training and degree in science, engineering, or medical fields

Tools

Word

Excel

PowerPoint

EndNote

Job description

Job Type: Full-Time, Remote

Experience Level: Experienced

At Criterion Edge, we’re committed to empowering companies to deliver better healthcare solutions. By leveraging best-in-class writing processes, technology, and expertise, we empower healthcare companies to achieve their global regulatory goals with superior quality, speed, and budget control. Be on the leading edge by applying your regulatory writing expertise and leadership skills to the development, management and writing of regulatory‑compliant performance evaluation reports (PER) projects with top industry clients.

In the role of Associate Medical Writer, you will have the opportunity to work closely with other writers, project managers and project support specialists to support and lead multiple PER writing projects that support EU IVDR submission requirements for the client’s portfolio of IVD products. Previous PER or CER writing experience and management of medical regulatory writers is required for this role.

The ideal candidate is looking to build their medical writing career and should possess basic 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 professional standards.

Specific responsibilities include:

• Take direction from other members of the project writing team on assigned writing tasks.
• Plan and organize your workload on assigned projects and tasks and adhere to established project timelines and workload estimates.
• Understand client and project expectations and work to meet those expectations through teamwork, adherence to deadlines, problem‑solving and scientific knowledge.
• Consistently monitor your work for accuracy and quality by following established internal QC processes.
• Work with Criterion Edge Project Manager to accurately document your assigned project tasks, task timeline estimates and assignments into the project plan. Provide weekly progress updates.
• Demonstrate initiative and sound judgement when faced with less familiar project requirements and/or document situations or challenges. Seek understanding and additional clarity from the Project Lead and/or Project Management before proceeding.
• Establish and maintain effective working relationships with co‑workers, managers, and clients.
• Attend internal meetings as needed.
• Previous experience writing CERs and/or PERs and related documents in accordance with MEDDEV 2.7/1 rev 4 and/or EU MDR and/or EU IVDR.
• Effective written, verbal and presentation skills in technical/laboratory diagnostics.
• Strong command of medical and laboratory terminology.
• Demonstrated ability to identify and adapt to shifting priorities and competing demands.
• Skilled in document development and management using Word, Excel, PowerPoint and EndNote.
• Training and degree in science, engineering, or medical field(s). Scientific/research background required, with a deep understanding of research design, methodology, and statistics.

How to apply:

If interested, please submit a resume/CV and a cover letter to [e-mail]. For more job openings, check our careers page.