Medical Writer

7 months ago


Sydney, Australia PSI CRO Full time

Company Description

PSI is a leading Contract Research Organization with more than 28 years in the industry offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

**Job Description**:

- Writes, edits, and reviews Essential Documents, including protocols, clinical study reports (CSRs), CSR safety narratives, informed consent forms, patient information, regulatory submission documents (e.g., sections for INDs/NDAs/BLAs), and other project-specific clinical documentation
- Ensures quality and compliance of PSI-developed Essential Documents with applicable QSDs, pertinent regulatory requirements, and client specifications
- Critically assesses, interprets, and summarizes data from clinical studies
- Reviews scientific literature and client source documents pertinent to medical writing activities
- Develops and maintains templates for study-specific documents and guidelines, conforming to client and regulatory requirements (as assigned by the Director or Associate Director, Medical Writing)
- Acts as a primary or secondary contact for the client and/or the sponsor (if not the same entity), and other PSI functional areas within the scope of assigned medical writing tasks

**Qualifications**:

- College or university degree, preferably a Bachelor’s/Master’s degree in biomedical or life science fields, or a PhD degree in medical/ journalism fields, or a relevant combination of education, training, and experience that presents the required knowledge, skills, and abilities.
- Minimum 2 years of corresponding industry experience working with clinical documentation and data
- Prior pharmaceutical, biotechnology, or contract research organization experience
- Excellent knowledge of global regulations and guidelines (FDA, ICH) on the drug development process and on production and publishing of Essential Documents
- Industry experience in preparation of ICH E3 compliant Clinical Study Reports (CSRs) and related documents

Additional Information

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.


  • Medical Writer

    1 month ago


    Sydney, Australia IQVIA Full time

    Want to join a company that focuses on creativity, innovation and challenges the ordinary? We’re looking for a passionate, creative and highly organised **Medical Writer** to join our dynamic team in **Sydney**. If this sounds like you, we’d love to meet you! **What Vivacity Health offers**: Vivacity Health, an IQVIA company, is a full-service, health...

  • Medical Writer

    6 months ago


    Sydney, Australia Montu Full time

    **Company Description** Montu is Australia’s largest medical cannabis company. With operations in Australia and Europe, we take a technology-first approach to improving the medical cannabis patient experience - whether it’s by delivering best-in-class online clinical care, or through our industry-leading product lines and innovative supply chain...

  • Medical Content Writer

    6 months ago


    North Sydney, Australia Lyfy Full time

    Lyfy (Lyfy.org) is creating the world’s first Lifestyle Medicine super app backed by medical experts, powered by AI and personalized for you. Lyfy offers personalized coaching, behaviour change strategies, and preventive care to help you lead a longer, healthier, and happier life. **The Role**: As a Medical Content Writer, you'll play a pivotal role in...

  • Medical Content Writer

    6 months ago


    North Sydney, Australia Lyfy Full time

    Lyfy (Lyfy.org) is creating the world’s first Lifestyle Medicine super app backed by medical experts, powered by AI and personalized for you. Lyfy offers personalized coaching, behaviour change strategies, and preventive care to help you lead a longer, healthier, and happier life. **The Role**: As a Medical Content Writer, you'll play a pivotal role in...


  • Sydney, Australia Envision Pharma Group Full time

    **Join us and make your mark at Envision Pharma Group! We're looking for passionate, motivated and driven medical professionals to join our growing APAC region.** Envision Pharma Group is a Technology Enabled Solutions Partner for the Life Science Industry with expertise in Commercialization, Value & Access, Artificial Intelligence, Data Analytics, and...


  • Sydney, Australia Cochlear Ltd Full time

    Cochlear is the global market leader in implant hearing solutions. Cochlear's mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. A Cochlear Implant is an electronic device that is surgically implanted under the skin near the ear that restores hearing to those who suffer...

  • Technical Writer

    3 months ago


    Sydney, Australia Cochlear Ltd Full time

    Cochlear is the global market leader in implant hearing solutions. Cochlear's mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. A Cochlear Implant is an electronic device that is surgically implanted under the skin near the ear that restores hearing to those who suffer...


  • Sydney, Australia Envision Pharma Group Full time

    **Join our Talent Community!** Envision Pharma Group is a Technology Enabled Solutions Partner for the Life Science Industry with expertise in Commercialization, Value & Access, Artificial Intelligence, Data Analytics, and Integrated Medical Capabilities. At our core, are our people, the manufacturers, and the patients our solutions impact and benefit...

  • Document Controller

    6 months ago


    Sydney, Australia UGL Limited Full time

    We work on challenging and exciting projects that shape the way we evolve, adapt and transform the industries we work in. We rally together, drawing on the diverse skills across our teams and create environments where great ideas are heard. UGL Defence has recently been awarded the contract to manage the Defence fuel related Asset Management, Operations and...

  • Grant Writer

    2 months ago


    Sydney, Australia Harrison.ai Full time

    **Why join us?** **\uD83D\uDC9C Do work that matters.** We’re pioneering AI software that will help diagnose medical images and raise the standard of healthcare for millions of people every day. \uD83C\uDF0F **Well-funded and global.** Annalise.ai has a global presence across APAC, EU and US regions. We’re powered by Harrison.ai (raised Australia’s...


  • Sydney, Australia Evolus Full time

    Medical Affairs Clinician Evolus is a performance beauty company with a customer-centric approach focused on delivering breakthrough products. We are seeking a driven, outgoing and seasoned aesthetic clinician. This field-based individual is someone who will increase awareness and education of Evolus products, respond to unsolicited training requests,...

  • Medical Monitor

    7 months ago


    Sydney, Australia Advanced Clinical Full time

    Medical Monitor (Australia-Wide) **Location**: Sydney NSW, Australia **Requisition Number** **351** **Remote** Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research...


  • Sydney, Australia Pfizer Full time

    Role Summary - The clinician medical monitor contributes towards providing medical and scientific expertise and oversight for Clinical Trials. - The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a compound or group of compounds Role Responsibilities Protocol...


  • Sydney, New South Wales, Australia Pivot Software Full time

    Pivot Software: Job Description About Us: Pivot Software is a dynamic company that aims to create engaging content across various channels. Job Summary: We are seeking an experienced Content Writer who will play a key role in creating compelling and informative content to enhance our brand and lead generation efforts. Reporting to the Chief Marketing...


  • Sydney, Australia 921 Pfizer Australia Pty Ltd Full time

    Role SummaryThe clinician medical monitor contributes towards providing medical and scientific expertise and oversight for Clinical Trials conducted worldwide with a primary focus in Japan and the Asia-Pacific region.The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain approval particularly...


  • Sydney, New South Wales, Australia Montu Full time

    About Montu BrandsMontu Brands is a pioneering company driving change and scaling at a rapid pace. We're passionate about improving the lives of hundreds of thousands of patients, and we're committed to facilitating a barrier-free recruitment process.Job SummaryWe're seeking an exceptional Brand Development Strategist/ Marketing Innovator to join our highly...


  • Sydney, Australia I-MED Full time

    **About I-MED**: Answers start with us I-MED is a global leader and ANZ's largest, privately owned radiology network. The work we do every day is at the core of providing quality medical imaging services to patients across over 240 clinics. When you work for I-MED you form part of a critical supply chain that supports emergency departments, obstetrics,...


  • Sydney, New South Wales, Australia 5Y8 Pfizer R&D Japan G.K Full time

    About 5Y8 Pfizer R&D Japan G.KAt 5Y8 Pfizer R&D Japan G.K, we are committed to delivering innovative solutions that improve human health. Our team of dedicated professionals works tirelessly to bring new treatments and vaccines to market, improving the lives of people around the world.Salary: ¥7,000,000 - ¥10,000,000 per year, depending on experienceJob...

  • Brand Manager

    1 month ago


    Sydney, Australia Montu Full time

    **Company Description** Montu is one of Australia's leading health tech businesses and a leader in alternative health services. With operations in Australia and Europe, we take a technology-first approach to reshaping the landscape for suppliers, practitioners, pharmacies and patients. Montu operates a fully integrated, end-to-end ecosystem of healthcare...


  • Sydney, New South Wales, Australia Goldman Sachs Full time

    About the RoleWe are seeking a highly skilled and experienced Strategic Healthcare Equity Research Analyst to join our team in Sydney. In this role, you will be responsible for conducting in-depth research on individual companies within the Healthcare sector, publishing reports, initiating sales calls, and marketing investment opinions.Your ImpactAs a key...