Technical Medical Writer (Remote / Flexible)

Overview

JOB DESCRIPTION:

We are a distinguished healthcare communications firm dedicated to providing comprehensive and accurate medical writing services for pharmaceutical, biotechnology, and medical device industries. With a commitment to clarity and precision, we specialize in transforming complex scientific data into accessible and impactful content that supports regulatory submissions, clinical research, and medical education.

As we continue to expand, we are looking for both experienced and emerging Technical Medical Writers to join our dynamic, remote team. This is an exciting opportunity for professionals at all levels to contribute to a wide range of high-stakes projects within the healthcare sector, while working in a flexible, supportive environment.

Position Summary:

The Technical Medical Writer will play a pivotal role in creating a broad spectrum of technical documents, such as regulatory submission materials, clinical trial reports, manuscripts for publication, and other scientific communications. Writers will work closely with interdisciplinary teams, including researchers, clinical experts, and project managers, to ensure that all content is scientifically accurate, compliant with regulatory standards, and tailored for the target audience.

This position is ideal for both seasoned writers with advanced expertise and early-career professionals eager to grow their skill set in a collaborative environment.

Core Responsibilities:

Regulatory Submissions: Draft and revise clinical documents, including protocols, investigator brochures, clinical study reports (CSRs), and regulatory submission packages (e.g., Investigational New Drug [IND] and Investigational Medicinal Product Dossier [IMPD]).
Scientific Communication: Develop high-quality, scientifically rigorous content for peer-reviewed publications, conference posters, abstracts, and other scientific materials.
Clinical Research Support: Collaborate with clinical researchers and statisticians to translate complex clinical trial data into clear and accurate documentation.
Cross-Functional Collaboration: Partner with multidisciplinary teams to gather information, provide feedback, and ensure consistency in content across documents.
Compliance Assurance: Ensure all content meets relevant regulatory standards, including FDA, EMA, and ICH guidelines, as well as GxP requirements.
Project Management: Manage timelines effectively to deliver high-quality content within specified deadlines, while balancing multiple projects.

Qualifications:

Education: A Bachelor’s degree in Life Sciences, Medical Writing, or a related field is required. A Master’s or PhD is a plus.

Experience:

Entry-Level: A minimum of 1-2 years of experience in medical writing, clinical research, or related fields is desirable but not mandatory. A strong interest in regulatory writing and scientific communication is essential.
Experienced: 3-5+ years of hands-on experience in technical medical writing, particularly in regulatory or clinical research documents.
Technical Skills: Exceptional writing and editing skills, with the ability to simplify complex scientific data. Familiarity with tools such as Microsoft Office Suite (Word, Excel, PowerPoint) and reference management software (e.g., EndNote, Zotero) is required.
Regulatory Knowledge: Knowledge of medical writing guidelines and regulations, including ICH E6, FDA, EMA, and GxP standards.
Soft Skills: Strong communication skills, attention to detail, and the ability to work independently while managing multiple priorities.
Remote Work Capability: Comfort with remote work, time zone flexibility, and self-motivation to thrive in a distributed team environment.

Preferred Qualifications:

For Entry-Level Candidates: Experience with academic writing, scientific research, or medical writing internships is a plus.
For Experienced Candidates: In-depth knowledge of clinical trial processes, experience writing clinical study reports (CSRs), and familiarity with therapeutic areas such as oncology, cardiology, or neurology.
Certifications: Medical writing certification (e.g., AMWA, EMWA) is desirable but not required.

Why Join Us?

Flexible Work Environment: Enjoy the flexibility of working remotely with a schedule that promotes a healthy work-life balance.
Competitive Compensation: We offer a competitive salary and benefits package, commensurate with experience.
Professional Development: Access to continuous learning opportunities, training, and career growth within a supportive team.
Dynamic Team: Collaborate with experts in the field in a culture that values excellence, innovation, and teamwork.