Manager Regulatory Medical Writing

1 week ago

United Kingdom The RFT Group Full time

Medical Regulatory Writing Manager Our client is a Biotech company with a strong pipeline, now wish to hire a Regulatory Medical Writing Manager working closely with functional teams e.g. Regulatory Affairs, Medical Writing, Clinical Operations, Medical Affairs, etc. The successful candidate will author, review and manage clinical documents, e.g., clinical study protocols and/or amendments, investigator brochures, clinical study reports and clinical summaries, and regulatory development documents for FDA, EMA, MHRA, etc. This hire will be work remotely from their own home office in the UK (must be resident there, with work authorisation), with occasional travel to their HQ office. The ideal candidate will be experienced in preparing, coordinating and managing Regulatory Submissions of clinical documents and writing clinical components for regulatory filings (NDA, BLA, MAA) within Pharma / Biotech environment. Requirements include: BSc in Life Sciences. Advanced Qualifications preferred i.e. PhD and Post Doctorate work. 8+ years Pharma / Biotech industry experience, 3 years of authoring, writing or editing of clinical documents for regulatory filings / submissions i.e. NDA, BLA, MAA within Pharma / Biotech environment. In-depth of knowledge writing or editing clinical trial documents, e.g., Protocols, IBs, CSRs and clinical summaries to ICH GCP and regulatory requirements. 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 skill 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 / larry@rftgroup.ie The RFT Group , BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. Follow us on Twitter, Facebook and LinkedIn

  • Manager Regulatory Medical Writing

    1 week ago

    United Kingdom The RFT Group Full time

    Medical Regulatory Writing Manager Our client is a Biotech company with a strong pipeline, now wish to hire a Regulatory Medical Writing Manager working closely with functional teams e.g. Regulatory Affairs, Medical Writing, Clinical Operations, Medical Affairs, etc. clinical study protocols and/or amendments, investigator brochures, clinical study...

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