AVANCE CLINICAL
Who are we?
We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry, you’ll know that we are experts in our field.
Why should you join Avance Clinical?
At Avance we know our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.
We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future
The opportunity
We’re looking for medical writers from Associate to Principal to join our existing team of 12. You’ll join an experienced, high performing team the majority of which have a PhD. You’ll work on a diverse range of therapeutic areas and get to really explore the science behind a project.
We’re seeking people that thrive in a positive environment, who are inquisitive and keen to have a genuine opportunity to learn and grow in a business that is expanding.
Your duties will include
- Preparation and review of IBs in accordance with ICH E6:R2.
- Preparation and review of CSPs in accordance with ICH E6:R2.
- Preparation and review of PICFs in accordance with Human Research Ethics Committee (HREC) guidelines.
- Preparation of CSRs in accordance with ICH E3.
- Preparation of any clinical study documents required as part of the MW range of services.
- Manage timelines and priorities for delivery of MW services in assigned projects.
- Maintain effective communication with other members of the analysis and report writing team.
- Provide and maintain effective communication with clients and other operational groups.
- Adhere to ICH GCP regulations, Avance Clinical guidelines and standard operating procedures (SOPs), as applicable.
- Assist in the development of templates and SOPs for MW team processes.
Qualifications, Skills and Experience
- Ordinary degree in a scientific or relevant discipline.
- PhD (desirable)
- Industry experience in appropriate positions that complement and enhance the requirements of this position (minimum 1 to 3 years of experience in the biotechnology/pharmaceutical/clinical research industry).
- Prior experience in preparation of IBs, CSPs, PICFs, CSRs or other clinical trial documents (highly desirable).
- Strong research report writing skills and/or demonstrated experience in writing peer reviewed journal articles.
- Knowledge of ICH GCP guideline, ICH E3 guideline, medical terminology and clinical trials processes.
- Excellent time management and organisational skills.
- Excellent oral and written communications skills.
- Demonstrated initiative, reliability and ability to work with minimal supervision.
- Willingness to work in and be supportive of a positive and dynamic team culture.
- Intermediate to advanced skills in MS Office suite.
What we offer
· Stimulating work
· Project diversity
· An intellectual challenge
· An agile & flexible workplace
· Opportunity to progress
· Stability
· Sense of community
· A leadership team that are working together on a common goal
· Flexible work options
· Great tools / tech to do your job
· A competitive salary & an extra days holiday for your birthday!
What next?
As a growing business we’re looking for likeminded people to join us – we hope that’s you.
- To join our team please submit your CV & cover letter as one Microsoft Word document
- You must also have full Australian working rights to be considered
· To apply for this role please click on the 'APPLY' link and submit your CV along with a cover letter. The cover letter should document why you would make a great addition to the Avance Clinical team. Please submit the CV and cover as one document.
· As we receive a high volume of applications for our vacancies, we will only contact you directly, should you be successful through to the next stage of our recruitment process.
· No agencies please
At Avance difference is encouraged, its celebrated and it's something we strive for. We empower cultural, disability, LGBTI+, and gender equality.