Senior Medical Writer (Remote)

TN United Kingdom; London; Remote; GBP 100,000 - 125,000; Full time

Job summary

An innovative and data-focused company is seeking a skilled regulatory writer with a strong background in the pharmaceutical industry. This role involves evaluating medical literature, writing clinical documents, and mentoring junior writers. The ideal candidate will have at least 3-5 years of experience in regulatory writing and a solid understanding of clinical data. Join a globally recognized CRO that values scientific rigor and customer satisfaction, and contribute to impactful projects that shape the future of drug development. If you are passionate about writing and thrive in a collaborative environment, this opportunity is for you.

Qualifications

• 3-5 years of regulatory and clinical medical writing experience required.
• Expert proficiency in MS Office tools is essential.

Responsibilities

• Evaluate and interpret medical literature for study design and significance.
• Write and edit clinical documents, ensuring compliance with regulatory standards.
• Mentor medical writers and manage project timelines effectively.

Skills

Regulatory Writing

Clinical Medical Writing

Exceptional Writing Skills

Organizational Skills

Client Communication

Team Leadership

Understanding of Clinical Data

Education

Bachelor's in Scientific Discipline

Master's in Scientific Discipline

Ph.D. in Scientific Discipline

Tools

MS Word

MS Excel

MS PowerPoint

Job description

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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, creating compelling submissions that meet rigorous regulatory standards.

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

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

Responsibilities

1. Under minimal supervision, 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 but not limited to clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials, and publications to medical journals.
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. Be highly proficient with styles of writing for various regulatory documents.
6. Have expert proficiency with client templates & style guides.
7. Interact directly and independently with clients to coordinate all facets of projects; demonstrate competent communication skills for projects.
8. Contribute substantially to, or manage, the production of interpretive guides.
9. Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary.
10. Mentor medical writers and other members of the project team who are involved in the writing process.

Requirements

1. At least 3 years of previous experience in the pharmaceutical industry.
2. Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience.
3. The ideal candidate would hold a Bachelors, Masters, or Ph.D. in a scientific, medical, or clinical discipline.
4. Substantial clinical study protocol experience, as lead author, required.
5. Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
6. Experience in regulatory submissions (clinical study reports) presented to regulatory authorities is a plus.
7. Understanding of clinical data is essential.
8. Exceptional writing skills are a must.
9. Excellent organizational skills and the ability to multi-task are essential prerequisites.
10. Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools.
11. Experience being a project lead, or managing a project team.
12. Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines is a plus.
13. Not required, but experience with orphan drug designations and PSP/PIPs is a plus.