Principal Medical Writer Editor

In this newly created role, we’re looking for an experienced Medical Writer to join us at Principal level & take responsibility for Quality Control (QC). You can work remotely from anywhere in Australia or if you wish from one of our offices – Adelaide, Brisbane, Melbourne, Sydney.

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
A Principal Medical Writing Editor is 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, a Principal Medical Writing Editor actively contributes to the ongoing execution of quality processes in the MW services area.

Core Medical Writing 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.
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 6 years of experience as a MW or Medical Writing Editor/Quality Control Reviewer with prior experience in preparation and/or 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 8 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.
Mentoring/leadership experience.
Excellent oral and written communications skills.
Demonstrated initiative, reliability and ability to work unsupervised.
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 – 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
You must have full Australian working rights to be considered