Medical Writer

Freyr Solutions; United Kingdom; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading regulatory services provider in the United Kingdom seeks a Medical Writer to conduct comprehensive quality control reviews of clinical regulatory documents. This full-time position, suited for a Mid-Senior level professional, involves verifying the accuracy and compliance of data presented in various therapeutic areas. Suitable candidates will demonstrate exceptional attention to detail and a commitment to maintaining high standards in regulatory documentation. Join a dynamic team with a focus on innovation and excellence.

Qualifications

• Proven track record in QC review of regulatory documents.
• Strong attention to detail in language, formatting, and data presentation.
• Ability to work across various therapeutic areas and phases.

Responsibilities

• Conduct thorough QC reviews of clinical documents against source data.
• Document QC findings accurately using appropriate tools.
• Ensure compliance with regulatory styles and standards.

Job description

Job Title

Medical Writer - Clinical

Location

United Kingdom

Duration

1 year fixed term employment

Job Description

• Comprehensive QC review of clinical sections of regulatory documents, including but not limited to, IBs, IND applications, NDAs, BLAs, CTAs, MAAs, briefing packages for regulatory agency meetings/advice, including verification of all references and source data, to achieve the highest quality from a technical, regulatory, and compliance perspective. Verify internal consistency within a document and across related documents.
• Comprehensive content QC of clinical data/reports.
• Documentation of QC findings in the appropriate manner/tool.
• Content QC activity is applicable for all therapeutic areas, development phases, modalities and geographic regions.
• Checking of data presented in text and tables/figures against source documents for consistency and accuracy.
• Verification of the data/content (100%) including text, tables, and figure as per the source documents.
• Review for grammar, punctuation, spelling and compliance with specified styles/standards.
• Maintenance of the QC records and checklists.

Seniority Level

Mid-Senior level

Employment Type

Full-time

Job Function

Other

Industry

Pharmaceutical Manufacturing

About Freyr

Freyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance.

You’ll join a collaborative, dynamic work environment that empowers our team to make a real impact.

We value growth, innovation, and excellence in regulatory services.

To apply, please visit our Careers page at https://www.freyrsolutions.com/careers/current-positions to explore current open positions and submit your application.