Scientific and Regulatory Associate - IP LogisticsThe SRA is responsible for supporting (IP) management and logistics activities and supporting the medical writing team as required.03rd March, 2025Who 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 1980s. If you already work in this industry, you’ll know that we are experts in our field.Why should you join Avance Clinical?We appreciate that 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. We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.Core ResponsibilitiesSupport IP management and logistics activities including but not limited to:IP label development and reviewIP shipping document preparation and reviewIP import/export permit preparationLiaison with Sponsor, Avance Clinical, third-party vendor, and site staff to facilitate timely management of IP preparation, packaging, labelling, distribution, and returns (as applicable)Assist in the preparation of pharmacy manuals and other relevant documents requiring investigational product expertise.Develop an extensive and up-to-date knowledge of Australian and international pharmacy, scientific and regulatory guidelines and GXPs (e.g., ICH E3, E6 (GCP), E8, E9 and E14, and PIC/S GMP).Develop familiarity with regulations and requirements relating to logistics and management of investigational medicinal products and investigational devices to enable the provision of advice to and/or resolution of inquiries/requests from prospective and existing clients, as appropriate.Departmental ResponsibilitiesActively contribute towards the ongoing development and growth of the scientific, regulatory, and medical consultancy business to support clients with their drug development programs and regulatory requirements, which may also include timeline projections, support with investigational product logistics and other vendor selections.Contribute to the development, creation and/or review of company documentation (including Standard Operating Procedures, Manuals, Study Plans, and forms/templates) to ensure compliance with regulatory requirements.Assist the VPGSRA in finance reporting for the Scientific and Regulatory Affairs Department.Participate in both internal and external audits as required.Qualifications, Skills and ExperienceB. Pharm (highly desirable), M.Sc. or Ph.D. in a scientific discipline or related field, or ordinary degree in Life sciences with appropriate industry experience.Minimum 2 years’ experience in the biotech/pharmaceutical/CRO/life science industry, including prior experience with clinical Research & Development.Understanding of applicable Australian and international Regulations, Acts and Guidance Documents relating to investigational products and clinical trials.Previous experience with logistics and management of investigational medicinal products or devices.Experience working in a GXP environment.Strong critical thinking to be able to interpret complex regulations and discern critical issues.Ability to manage competing priorities and deliver critical information in a timely manner.Effective organizational, planning and negotiation skills.Proven ability to work effectively in a team environment.Strong interpersonal skills with the ability to build strong working relationships and manage internal and external stakeholders.Ability to work independently on multiple tasks in a fast-paced environment.Strong decision-making and analytical skills.What we offerStimulating workAn 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 day’s 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.At Avance, difference is encouraged, it's celebrated and it's something we strive for. We empower cultural, disability, LGBTI+, and gender equality.
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