Principal Medical Writer Editor

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.

• 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.

• 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!

• 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

  
At Avance difference is encouraged, its celebrated and it's something we strive for. We empower cultural, disability, LGBTI+, and gender equality.
  
  
Medical Writer / Biotech / CRO / Adelaide / Brisbane / Melbourne / Sydney / Perth / PhD / QC / Quality Control