Job Description
Our client is a Biotech company with an exciting pipeline of drug compounds in development, now have approval for a newly created role of Senior Medical Writer within Clinical Development for early-stage and late-stage studies. This hire will be based in Ireland or Europe and will have flexibility to work remotely from their own home office and occasional travel to Dublin office.
The successful candidate will support early-stage clinical studies; through leading the development and writing clinical trial documents, e.g., clinical investigation protocols, investigator brochures, monitoring manuals, clinical study reports and clinical summaries. This role will report to the Head of Clinical Development and work closely with Clinical Operations, Regulatory Affairs and Medical Affairs.
This role will suit a highly qualified and experienced Medical Writer, who has depth of experience supporting Clinical Development and has a flexible working style, with ability to work independently, remotely and in teams in a dynamic and fast changing Biotech environment.
Responsibilities include:
- Ensuring discussion points and company messaging is conveyed in a consistent scientific manner across documents
- Generating templates and ensuring alignment across documents
- Supporting applications to authorities and drafting briefing packages
- Driving trial team participation in the preparation of such documents, including facilitating meetings, developing and managing timelines, document review, and decisions
- Updating clinical and non-clinical regulatory documents throughout their lifecycle
- Overseeing publications of key guidelines within relevant diseases and support internal training
- Coordinating and supervising outsourced medical writing activities
- Supporting publications and internal and external training materials
- Supporting development of communication material
- PhD in Life Sciences and 3 years’ experience as a post-doc.
- 3+ years’ experience as a Medical Writer within the Pharma or Biotech industry.
- Depth of knowledge and experience on clinical development, with excellent understanding of ICH GCP and regulatory requirements
- Proven experience authoring clinical components in regulatory filings (NDA, BLA, MAA) highly preferred.
- In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents and ability to identify deficiencies, errors, and inconsistencies in a protocol or report.
- 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
- Flexible working style with ability to work independently, remotely and in teams
- Excellent attention to detail.
- Fluent in English.
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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