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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.
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