Principal Medical Writer, Regulatory
Our client is a Biotech company with a strong pipeline, now wish to hire a Principal Medical Writer 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/or 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, operating at Senior or Principal level,of clinical documents in clinical research, and writing clinical components in regulatory filings (NDA, BLA, MAA) within Pharma / Biotech environment.
Responsibilities include:
* Liaise with medical/clinical experts, statisticians, investigators, and other relevant stakeholders during document development.
* Updating clinical and non-clinical regulatory documents throughout their lifecycle.
* Supporting applications to authorities and drafting briefing packages.
* Overseeing 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.
* Supporting development of communication material and ensuring company messaging is conveyed in a consistent scientific manner across documents.
* Generating templates and ensuring alignment across documents.
* Support the development of communication material.
Qualification and experience requirements include:
* BSc in Life Sciences. Advanced Qualifications preferred i.e. PhD and Post Doctorate work.
* 5+ years Pharma / Biotech industry experience, 2 years of which in Regulatory Medical Writer role or similar.
* In-depth of 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 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. www.rftgroup.ie
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