Principal Medical Writer - Remote

TN United Kingdom; London; Remote; GBP 60,000 - 100,000; Full time

Job summary

An innovative CRO is seeking a Principal Medical Writer to join their remote team in London. This role involves evaluating and interpreting medical literature, writing clinical development documents, and ensuring adherence to regulatory standards. The ideal candidate will have substantial experience in regulatory writing, particularly with clinical study protocols, and possess strong organizational and communication skills. Join a forward-thinking company that prides itself on its data-driven approach and commitment to excellence in the pharmaceutical and biotech industries. Be part of a team that values customer satisfaction and innovation in clinical trial transparency.

Qualifications

• 6+ years of regulatory writing experience with advanced degrees preferred.
• Extensive experience in clinical study protocols as lead author.

Responsibilities

• Write and edit clinical development documents ensuring scientific rigor.
• Interact independently with clients demonstrating strong communication.

Skills

Regulatory Writing

Clinical Study Protocols

Project Management

Communication Skills

Organizational Skills

Education

Bachelor's in Science

Master's or PhD in a related field

Tools

MS Word

MS Excel

MS PowerPoint

Job description

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Principal Medical Writer - Remote, London

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Client:

MMS

Location:

London, United Kingdom

Job Category:

-

EU work permit required:

Yes

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Job Reference:

bc2123c4b543

Job Views:

14

Posted:

29.04.2025

Expiry Date:

13.06.2025

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Job Description:

MMS is an innovative, data-focused CRO supporting the pharmaceutical, biotech, clinical trial transparency, and medical device industries with a scientific approach to complex trial data and regulatory submission challenges.

Strong industry experience, technology-enabled services, and a data-driven approach make MMS a valuable CRO partner, creating compelling submissions that meet regulatory standards.

With a global presence across four continents, MMS maintains a 97% customer satisfaction rating and has been recognized as a leading CRO in Global Health & Pharma’s international awards for three consecutive years.

For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.

Responsibilities:

• Evaluate, analyze, and interpret medical literature to select primary resource materials, ensuring study design, statistical significance, scientific rigor, and absence of bias.
• Write and edit clinical development documents, including protocols, investigator’s brochures, clinical study reports, consent forms, safety and efficacy summaries, and publication materials.
• Complete writing assignments timely, maintaining workflow and timelines.
• Practice excellent customer service internally and externally.
• Proficiently utilize styles for various regulatory documents, adhering to client templates and style guides.
• Interact independently with clients to coordinate project aspects, demonstrating strong communication skills.
• Contribute to or manage the production of interpretive guides.
• Take ownership of assignments, consulting team members and departments as needed.
• Mentor medical writers and project team members involved in writing processes.

Requirements:

• Bachelor’s, Master’s, or PhD in a scientific, medical, clinical discipline, or related field; at least 6 years of regulatory writing experience; advanced degrees preferred.
• Extensive experience in clinical study protocols, especially as lead author.
• Experience managing teams and authoring regulatory documents under tight deadlines.
• Experience with regulatory submissions (clinical study reports) is advantageous.
• Understanding of clinical data and exceptional writing skills.
• Strong organizational skills and ability to multitask.
• Expertise in MS Word, Excel, PowerPoint, and related tools.
• Experience as a project lead or managing project teams.
• Knowledge of federal regulations, GCP, and ICH guidelines; experience with orphan drugs and PIPs is a plus.