Clinical Trials Document Reviewer/Editor/Medical Writer / Quality Control or Quality Assurance Medical Writer
In this newly created role, we’re looking for someone who is experienced and has a love of reviewing/editing documents related to early phase clinical trials.
If you’re already based in Australia, you can work remotely from anywhere in the country or, if you wish, from one of our offices - Adelaide, Brisbane, Melbourne, Sydney.
Due to the specialist nature of this role we’re happy to provide sponsorship & relocation support provided you’re happy to be based from our Adelaide office.
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.
You’ll be joining a high performing, supportive, established team of 12 experienced Medical Writers most of which have a PhD.
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.
Broad Purpose
You’ll be responsible for Quality Control (QC) review of documents prepared by medical writers (including Investigator Brochure’s [IBs], Clinical Study Protocols [CSPs], Participant Information and Consent Forms [PICFs], Clinical Study Reports [CSRs] or any other clinical study documents required as part of the medical writing [MW] range of services) for readability, GCP and regulatory compliance, consistency of content and style and verification of included data and scientific conclusions.
Furthermore, you’ll actively contribute to the ongoing execution of quality processes in the MW services area.
Core Responsibilities
- QC review of IBs in accordance with ICH E6:R2.
- QC review of CSPs in accordance with ICH E6:R2.
- QC review of PICFs in accordance with Human Research Ethics Committee (HREC) guidelines.
- QC review of CSRs in accordance with ICH E3.
- Establish and monitor QC/Quality Assurance (QA) processes within the medical writing team to ensure documents are prepared to GCP and regulatory standards.
- Preparation of any clinical study documents in the MW range of services, if required.
- Manage timelines and priorities for delivery of MW services in assigned projects.
- 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.
- Other duties as directed by Line Management or delegate in line with skills, experience and/or qualifications.
Qualifications, Skills And Experience
- Higher degree or specialised qualifications in a scientific (or relevant) discipline.
- Minimum 4 years of experience in document review or as a medical writer with a focus on QC/QA.
- Prior experience in review of clinical trial regulatory documents (including, IBs, CSPs, PICFs, CSRs or other relevant clinical trial documents).
- Industry experience in appropriate positions that complement and enhance the requirements of this position (minimum 6 years of experience in the biotechnology/pharmaceutical/clinical research industry).
- 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.
- Knowledge of statistics and data analysis and presentation methods (desirable).
- Knowledge of pharmacokinetics (desirable).
- Excellent time management and organisational skills.
- Excellent oral and written communications skills.
- 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 - work from home
- 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
Alternatively, you could pick up the phone and call our Senior Talent Acquisition Specialist Adrian Bedford 0406 574234 / Adrian.bedford@avancecro.com
At Avance difference is encouraged, its celebrated and it's something we strive for. We empower cultural, disability, LGBTI+, and gender equality.
Medical Writer / Document Review / Editor / Biotech / CRO / Adelaide / Brisbane / Melbourne / Sydney / Perth / South Africa / United Kingdom / PhD / QC / QA / Quality Control / Relocation
