Job Description
Position – Medical Writing Editor
Location – Adelaide, South Australia
Company – Avance Clinical
Salary - $110,000 to $120,000
Avance Clinical is a Contract Research Organisation which offers specialised services supporting drug development for the pharmaceutical and biotechnology industry.
A Technical Writer / Medical Writing Editor is responsible for researching, writing, and editing technical documentation and clinical study materials. This role encompasses the authorship and Quality Control (QC) review of documents prepared within the medical writing team (including Investigator Brochure’s [IBs], Clinical Study Protocols [CSPs], Participant Information and Consent Forms [PICFs], Clinical Study Reports [CSRs], and any other clinical study documents required as part of the medical writing [MW] range of services). Documentation is reviewed and authored for technical accuracy, readability, GCP and regulatory compliance, consistency of content and style, and verification of included data and scientific conclusions.
Furthermore, a Technical Writer / Medical Writing Editor actively contributes to the development and maintenance of quality processes, templates, and technical standards in the Medical Writing (MW) services area.
Core Responsibilities
Technical Writing and Documentation Responsibilities
Research, author, and develop technical clinical documentation including IBs, CSPs, PICFs, CSRs, and other clinical study documents in the MW range of services.
Write and prepare technical study documents in accordance with applicable regulatory guidelines and scientific standards, ensuring clarity, accuracy, and accessibility for intended audiences.
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 ICH E6:R2 and Human Research Ethics Committee (HREC) guidelines.
QC review of CSRs in accordance with ICH E3.
QC review of any clinical study documents in the MW range of services.
Research and incorporate scientific data, statistical outputs, and clinical findings into clearly written technical documents suitable for regulatory submission.
Manage timelines and priorities for delivery of MW services in assigned projects.
Provide and maintain effective communication with clients and internal functional 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.
Departmental Responsibilities
Participate in client meetings and both internal and external audits, as required.
Contribute to ongoing quality review within the MW department as required, including internal reviews of documents and forms to ensure they are appropriate for use.
Research, prepare, and develop technical writing templates, style guides, and SOPs for MW team processes to ensure consistency and quality of technical documentation output.
Assist in establishing and monitoring QC processes within the MW team to ensure documents are prepared to GCP and regulatory standards. Assist with SDMWS departmental responsibilities as required.
Organisational Responsibilities
Embrace the core values of Avance Clinical and endeavour to display those attributes at all times with clients and staff alike.
Commit to Avance Clinical training programs.
Adhere to Avance quality systems.
All staff are required to take reasonable care for their own health and safety and that of other personnel who may be affected by their conduct.
The accountabilities as specified above may be altered in accordance with the changing requirements of the position.
Qualifications, Skills and Experience
Ordinary degree in a scientific or relevant discipline and/or communications/publishing/editing/technical writing.
Higher degree or specialised qualifications in a scientific (or relevant) discipline (desirable).
Minimum 2 years of experience as a Technical Writer, Medical Writer, Medical Writing Editor/Quality Control Reviewer, Technical Editor, or Quality Assurance Specialist with prior experience in the research, 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 (biotechnology/pharmaceutical/clinical research industry) (desirable).
Strong technical research report writing skills and/or demonstrated experience in writing peer reviewed journal articles or regulatory submissions.
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 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
At Avance difference is encouraged, its celebrated and it's something we strive for. We empower cultural, disability, LGBTI+, and gender equality.
Pay: $110,000.00 – $120,000.00 per year
Work Location: In person
Location – Adelaide, South Australia
Company – Avance Clinical
Salary - $110,000 to $120,000
Avance Clinical is a Contract Research Organisation which offers specialised services supporting drug development for the pharmaceutical and biotechnology industry.
A Technical Writer / Medical Writing Editor is responsible for researching, writing, and editing technical documentation and clinical study materials. This role encompasses the authorship and Quality Control (QC) review of documents prepared within the medical writing team (including Investigator Brochure’s [IBs], Clinical Study Protocols [CSPs], Participant Information and Consent Forms [PICFs], Clinical Study Reports [CSRs], and any other clinical study documents required as part of the medical writing [MW] range of services). Documentation is reviewed and authored for technical accuracy, readability, GCP and regulatory compliance, consistency of content and style, and verification of included data and scientific conclusions.
Furthermore, a Technical Writer / Medical Writing Editor actively contributes to the development and maintenance of quality processes, templates, and technical standards in the Medical Writing (MW) services area.
Core Responsibilities
Technical Writing and Documentation Responsibilities
Research, author, and develop technical clinical documentation including IBs, CSPs, PICFs, CSRs, and other clinical study documents in the MW range of services.
Write and prepare technical study documents in accordance with applicable regulatory guidelines and scientific standards, ensuring clarity, accuracy, and accessibility for intended audiences.
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 ICH E6:R2 and Human Research Ethics Committee (HREC) guidelines.
QC review of CSRs in accordance with ICH E3.
QC review of any clinical study documents in the MW range of services.
Research and incorporate scientific data, statistical outputs, and clinical findings into clearly written technical documents suitable for regulatory submission.
Manage timelines and priorities for delivery of MW services in assigned projects.
Provide and maintain effective communication with clients and internal functional 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.
Departmental Responsibilities
Participate in client meetings and both internal and external audits, as required.
Contribute to ongoing quality review within the MW department as required, including internal reviews of documents and forms to ensure they are appropriate for use.
Research, prepare, and develop technical writing templates, style guides, and SOPs for MW team processes to ensure consistency and quality of technical documentation output.
Assist in establishing and monitoring QC processes within the MW team to ensure documents are prepared to GCP and regulatory standards. Assist with SDMWS departmental responsibilities as required.
Organisational Responsibilities
Embrace the core values of Avance Clinical and endeavour to display those attributes at all times with clients and staff alike.
Commit to Avance Clinical training programs.
Adhere to Avance quality systems.
All staff are required to take reasonable care for their own health and safety and that of other personnel who may be affected by their conduct.
The accountabilities as specified above may be altered in accordance with the changing requirements of the position.
Qualifications, Skills and Experience
Ordinary degree in a scientific or relevant discipline and/or communications/publishing/editing/technical writing.
Higher degree or specialised qualifications in a scientific (or relevant) discipline (desirable).
Minimum 2 years of experience as a Technical Writer, Medical Writer, Medical Writing Editor/Quality Control Reviewer, Technical Editor, or Quality Assurance Specialist with prior experience in the research, 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 (biotechnology/pharmaceutical/clinical research industry) (desirable).
Strong technical research report writing skills and/or demonstrated experience in writing peer reviewed journal articles or regulatory submissions.
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 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
At Avance difference is encouraged, its celebrated and it's something we strive for. We empower cultural, disability, LGBTI+, and gender equality.
Pay: $110,000.00 – $120,000.00 per year
Work Location: In person
💡 Quick Summary
Seeking a career-building opportunity? The Medical Writing Editor position is now open for candidates interested in the BPO Jobs sector. This role in Adelaide offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in BPO Jobs is a plus.