Medical Writer

Freyr Solutions; Birmingham; On-site; GBP 30,000 - 50,000; Full time

Job summary

A leading regulatory solutions provider in Birmingham seeks a Medical Writer to conduct comprehensive QC reviews of clinical regulatory documents. The ideal candidate should have experience in reviewing submission documents such as INDs, NDAs, and MAAs, ensuring accuracy and compliance. Responsibilities include verifying data consistency and maintaining QC records. This role offers a one-year fixed-term employment opportunity, contributing to the excellence in regulatory services within the Life Sciences industry.

Qualifications

• Experience in QC review of clinical regulatory documents.
• Strong attention to detail with technical and compliance focus.
• Excellent grammar and writing skills.

Responsibilities

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

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.