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Full Job Description
Responsibilities:
Perform Quality Checks of clinical and submission documents to ensure compliance with SOPs, GCP and other applicable regulatory requirements.
Assist the Medical Writer to collate Clinical Study Reports and maintain electronic filing in ESMS and Trial Master File.
Prepare sections of study documents eg, Clinical Study Reports and protocols under supervision of the lead Medical Writer
Format documents and ensure that they meet technical specifications required for publishing.
Assist the Medical Writing in co-ordination of reviews.
Perform Quality Checks of information for protocol registration and results posting.
Qualifications:
- Bachelor degree, or equivalent in Science-related discipline
- An advanced degree desired (MSc, PhD preferred)
- 0-2 years experience of working within the CRO/Pharma/Biotech industry
Our Benefits
CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL Seqirus employee.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.
We want CSL Seqirus to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL Seqirus!
Watch our ‘On the Front Line’ video to learn more about CSL Seqirus
