Join our growing company - if you have regulatory medical writing experience we'd love to hear from you.Australian based role.11th October, 2024As part of our continued company expansion, we're seeking an experienced regulatory Medical Writer to join us at Senior or Principal level.You can work remotely (WFH) 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 14 experienced Medical Writers most 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.Broad PurposeYou'll be responsible for the coordination, writing and editing of Investigator Brochure's (IBs), Clinical Study Protocols (CSP), 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.The role also serves as a primary MW technical contact for other Avance departments and the client, for any clinical study documents assigned to be prepared, as well as mentors Medical Writers on MW tasks and maintaining quality processes.Qualifications, Skills and ExperienceOrdinary degree in a scientific or relevant discipline.Higher degree in scientific or relevant discipline (desirable).Minimum 3 years of experience as a MW with prior experience in preparation of IBs, CSPs, PICFs, CSRs or other 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.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 offerStimulating workProject diversityAn intellectual challengeAn agile & flexible workplaceOpportunity to progressStabilitySense of communityA leadership team that are working together on a common goalFlexible work optionsGreat tools / tech to do your jobA 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 documentYou must have full Australian working rights to be consideredAlternatively, you could pick up the phone and call our Principal Talent Acquisition Specialist Adrian Bedford 0406 574234 / ****** Avance difference is encouraged, it's celebrated and it's something we strive for.We empower cultural, disability, LGBTI+, and gender equality.#J-18808-Ljbffr