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 be the first hire within Medical Writing; therefore, you will establish this role being the SME for all things Medical Writing, procedures, processes, etc. and eventually build team. Reporting to the Head of Clinical Development and work closely with all levels within Clinical Operations, Regulatory Affairs and Medical Affairs. This hire will lead the development and writing clinical trial documents, e.g., clinical investigation protocols, investigator brochures, monitoring manuals, clinical study reports and clinical summaries, across all studies.
The ideal candidate will be an experienced Medical Writer within Clinical Development/Research, who has a flexible and adaptable working style, with ability to work independently and in cross-functional teams in a dynamic and fast changing Biotech environment.
Responsibilities include:
- Driving trial team participation in the preparation of such documents, including facilitating meetings, developing and managing timelines, document review, and decisions
- Supporting applications to authorities and drafting briefing packages
- 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 and ensuring company messaging is conveyed in a consistent scientific manner across documents
- Generating templates and ensuring alignment across documents
Qualification and experience requirements include:
- PhD in Life Sciences and 3 years’ experience as a post-doc.
- 4+ 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
- Excellent English (written and spoken), with 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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