Principal Medical Writer

The RFT Group; Dublin; Hybrid; EUR 65,000 - 85,000; Full time

Job summary

A leading recruitment agency in biotech is seeking a Senior Regulatory Medical Writer to join a Biotech company in Dublin. This role involves authoring and managing clinical documents for regulatory submissions and requires 5+ years of experience in Pharma/Biotech. Remote work is available with occasional office visits. Excellent communication and analytical skills are essential.

Qualifications

• 5+ years experience in Pharma/Biotech, including 2 years in Regulatory Medical Writer role.
• In-depth knowledge of ICH GCP and regulatory requirements.
• Strong analytical skills and understanding of statistical methods.

Responsibilities

• Author and manage clinical documents for regulatory submissions.
• Liaise with clinical experts during document development.
• Support applications to authorities and draft briefing packages.

Skills

Regulatory writing

Clinical documents

Analysis skills

Attention to detail

Communication skills

Education

BSc in Life Sciences

PhD or Post Doctorate

Job description

Overview

Senior Regulatory Medical Writer, Biotech. Our client is a Biotech company with a strong pipeline and wishes to hire an experienced Regulatory Medical Writer (Senior to Principal level) within their Clinical Development team, working closely with functional teams e.g. Clinical Operations, Regulatory Affairs, Medical Affairs, Commercial, etc.

The successful candidate will author, review and manage clinical documents, e.g., clinical study protocols and amendments, investigator brochures, clinical study reports and clinical summaries, and regulatory development documents for FDA, EMA, MHRA, etc.

This hire will be based in either Ireland or the UK, with flexibility to work remotely from their own home office, with occasional travel to their office.

The ideal candidate will be an experienced Medical / Regulatory Writer of clinical documents in clinical research, and writing clinical components in regulatory filings (NDA, BLA, MAA) within Pharma / Biotech environment.

Responsibilities

• Liaise with medical/clinical experts, statisticians, investigators, and other relevant stakeholders during document development.
• Update clinical and non-clinical regulatory documents throughout their lifecycle.
• Support applications to authorities and draft briefing packages.
• Oversee publications of key guidelines within relevant diseases and support internal training.
• Draft literature reviews, abstracts, posters, slide decks, working from various data sources including clinical study reports, protocols, etc.
• Coordinate trial team participation in the preparation of such documents, including facilitating meetings, developing and managing timelines, document review, and decisions.
• Support development of communication material and ensure company messaging is conveyed in a consistent scientific manner across documents.
• Generate templates and ensure alignment across documents.
• Support the development of communication material.

Qualification and experience requirements

• BSc in Life Sciences. Advanced qualifications preferred e.g. PhD and Post Doctorate work.
• 5+ years Pharma / Biotech industry experience, 2 years of which in Regulatory Medical Writer role or similar.
• In-depth knowledge writing or editing clinical trial documents, e.g., Protocols, IBs, CSRs and clinical summaries to ICH GCP and regulatory requirements.
• Experience in preparation of clinical components in regulatory filings (NDA, BLA, MAA) is preferred.
• Strong analytical skills including good understanding of common statistical methods used in clinical trials and interpretation of their results.
• High quality standards and is committed to meet deadlines.
• Excellent written and oral communication skills within medical/science area.
• Solid ability to perform background literature research.
• Excellent English (written and spoken).
• Excellent attention to detail.

For further details, please contact Larry on +353 1 – 2302400 / [e-mail]

The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie

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