About Us:

UNIQ Trials is a full-service Contract Research Organization (CRO) dedicated to navigating the complexities of bringing new medical products to market. With a legacy of excellence that began 15 years ago we have grown from a small, passionate team into a global network of experts committed to delivering high-quality services in medical writing, clinical monitoring, project management, biostatistics, data management, safety and medical monitoring, and quality assurance. Our international team continues to deliver innovative clinical trial solutions across diverse therapeutic areas, ensuring the success of every study we manage.

The role:

In this dynamic role, you will contribute to all aspects of medical and regulatory writing with a focus on oversight, independent QC, and hands-on development of key documents, particularly those that are time-sensitive or require internal ownership.
 
Key responsibilities include:

• Preparation of high-quality clinical and regulatory documents.
• Managing the full document lifecycle from drafting through review, amendment, and finalization
• Acting as an independent QC layer, ensuring documents comply with GCP, internal processes, and applicable local and international regulations
• Supporting low-level regulatory affairs activities, including administrative back-and-forth associated with IND submissions
• Final PDF publishing and preparation of documents for regulatory submissions
• Collaborating with cross-functional internal teams and external partners to deliver high-quality documents aligned to project timelines
• Maintaining accurate and up-to-date information in project trackers, regulatory databases, and document management systems
• Providing operational and administrative support across medical and regulatory activities where required
• Supporting programs across US and EMEA regulatory landscapes
• Developing and maintaining scientific, medical, and technical knowledge relevant to the company’s clinical studies.

To be successful in the role, we’re looking for candidates with:

• A minimum of 3+ years’ experience in medical/scientific writing within pharma, biotech, CRO, medical communications, or related industries
• A solid understanding of the clinical trial environment (GxP) and applicable regulatory guidelines
• Experience translating complex scientific concepts into clear, plain-language documents
• Exposure to regulatory writing and low-level RA activities
• Exceptional written and verbal communication skills and strong gramma

The Environment

• Hands-off management style with strong support when needed
• Open, collaborative culture
• Fast-paced work with demanding deadlines — efficiency and accuracy are critical
• Opportunity for growth and progression as the organisation scales
• Flexible locations and remote working arrangements.