- Datapharm Australia is a leading local contract research organisation (CRO) providing clinical trial management and data analysis and reporting for local and global pharma and biotech companies
- We are looking for an experienced Medical Writer who wants to be involved in the many aspects of medical writing for clinical studies
Medical Writer Role:
The role will involve the following writing tasks:
- Write Protocol synopsis for new study designs
- Write Full protocol for industry sponsored or investigator-initiated studies
- Write Investigator brochure for new products to present to Ethics Committee
- Write Patient Informed Consent Forms (PICF)
- Review HREC applications
- Write Clinical Study Report (CSR) according to ICH E3 guidelines
- Conduct literature surveys to support discussion in reports
- Write draft publications, papers, posters, presentations
- Participate in training and mentoring others in clinical team
- Stay actively informed on regulatory requirements for clinical writing
Essential: Must have:
- Either Medical Degree or PhD in Health or Biological Science or Postgraduate Qualifications that include Research Methodology
- Experience in writing about clinical trials and in research methodology
- Familiarity with ICH guidelines and other regulatory requirements
- Excellent English written and verbal skills
- Good time management and organisational skills and ability to meet deadlines.
- Eye for detail and accuracy and emphasis on the importance of quality
- Willingness to train and become accredited as a Certified Medical Publication Professional through examination.
- Advanced skills in use of Microsoft Word, Adobe Professional, publishing software
- Skills in literature searching, summarising literature and adding references to reports
- Willingness to train in other roles in the organisation including monitoring or pharmacovigilance if required
- Strong verbal communication skills for client presentations and training the team
- Enthusiasm and willingness to take on a leadership role in a busy interactive and interdependent team
Datapharm Australia Pty Ltd is a contract research organisation (CRO) (www.datapharmaustralia.com ). Datapharm provides support to pharmaceutical and biotechnology companies in clinical research by setting up and monitoring clinical trials, collecting and analysing the data from these studies. Datapharm, established in 1987, has a strong position in the industry. Its statisticians provide study design, statistical analysis and reports for many clinical studies each year. A strong reputation for quality and excellence in these areas is resulting in our workload growing.
Other: You must have the right to live and work in Australia to apply for this job. This position is full-time or part-time in-house. Datapharm Australia is Sydney based at Drummoyne offices – We are a family friendly workplace. Datapharm reserves the right not to proceed with any appointment.
Salary will be negotiated according to experience and qualifications.
Please log onto our website to apply and send your application, CV, copies of your university transcripts and at least two referees by clicking on this link: https://datapharmaustralia.com/careers/. Your details will be kept confidential within our company.
Datapharm Australia: 56/56A Thompson St, Drummoyne, 2047, NSW – Phone : 02 9719 2800