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Principal Medical Writer - Remote, Greater London
Client:
MMS
Location:
Greater London, United Kingdom
EU work permit required:
Yes
Job Reference:
bc2123c4b543
Job Description:
MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner.
Responsibilities:
1. Critically evaluate, analyze, and interpret medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor, and absence of bias.
2. Write and edit clinical development documents, including clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, and presentation materials.
3. Complete writing assignments in a timely manner and maintain timelines and workflow of writing assignments.
4. Practice good internal and external customer service.
5. Interact directly and independently with clients to coordinate all facets of projects; demonstrate competent communication skills.
6. Take ownership of assignments and proactively consult with project team members for information or guidance as necessary.
7. Mentor medical writers and other project team members involved in the writing process.
Requirements:
1. Bachelor’s, Master’s or PhD Degree in scientific, medical, clinical discipline or related field with at least 6 years of previous regulatory writing experience; Master’s or PhD preferred.
2. Substantial clinical study protocol experience as lead author required.
3. Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
4. Exceptional writing and organizational skills, with the ability to multi-task.
5. Expert proficiency in MS Word, Excel, PowerPoint, and related word processing tools.
6. Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines.
7. Experience with orphan drug designations and PSP/PIPs is a plus.
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