Medical Writer

Freyr Solutions; Leeds; On-site; GBP 35,000 - 50,000; Full time

Job summary

A regulatory solutions firm in Leeds is seeking a Medical Writer - Clinical to conduct comprehensive quality control reviews of clinical regulatory documents. This role emphasizes meticulous scrutiny of data, ensuring consistency and compliance with regulatory standards. The ideal candidate should possess strong attention to detail and experience in reviewing complex regulatory documents. This is a one-year fixed-term employment opportunity that offers a chance to contribute significantly to regulatory excellence.

Qualifications

• Experience in regulatory document review is essential.
• Ability to maintain high quality and consistency across documents is required.
• Familiarity with clinical data and reports is necessary.

Responsibilities

• Perform QC review of clinical regulatory documents.
• Document QC findings accurately.
• Ensure consistency and accuracy of data presented.

Skills

Attention to detail

Regulatory knowledge

QC document review

Grammar and style adherence

Job description

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.

Why Freyr?

At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint, we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.

Join Our Team

If you're ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr. Together, we can shape the future of regulatory solutions.

📢 To Apply

Please apply to this job post or you can visit our Careers page for more openings.

Visit our Careers page at https://www.freyrsolutions.com/careers/current-positions to explore current job openings and submit your application.

Don't miss this chance to be a part of Freyr's expansion and make your mark in the world of regulatory services. Let's redefine regulatory excellence together!

Position

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, Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologic License Applications (BLAs), Clinical Trial Applications (CTAs), Marketing Authorization Applications (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.