Clinical Trial Regulation Specialist

3 weeks ago


Gold Coast, Queensland, Australia Pharmiweb Full time
{"title": "Regulatory Expert for Global Submissions Management", "description": "Job Summary

We are seeking a highly skilled Regulatory Expert for Global Submissions Management to join our team in Serbia. The successful candidate will have a deep understanding of EU-CTR and CTIS processes and will be responsible for managing global submissions, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to achieve project goals.


Key Responsibilities
  • Manage global submissions, including preparing and submitting documents to regulatory authorities
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements
  • Develop and maintain knowledge of EU-CTR and CTIS processes
  • Provide guidance and support to colleagues on regulatory matters

Qualifications
  • Bachelor's degree in a relevant field
  • Minimum 2 years of experience in regulatory affairs
  • Strong knowledge of EU-CTR and CTIS processes
  • Excellent communication and interpersonal skills
  • Ability to work independently and as part of a team

About Us

Syneos Health is a leading fully integrated biopharmaceutical solutions organization. We are committed to accelerating customer success through innovative clinical development and commercialization solutions.


As a Regulatory Expert for Global Submissions Management, you will have the opportunity to work with a talented team of professionals who share your passion for regulatory affairs. We offer a dynamic and challenging work environment, with opportunities for professional growth and development.


If you are a motivated and experienced regulatory professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

"}

  • Gold Coast, Queensland, Australia Bond University Full time

    About the PositionBond University's Institute for Evidence-Based Healthcare is seeking a dedicated Clinical Trial Coordinator to join our dynamic, multidisciplinary team. As a key member of our team, you will be responsible for overseeing the day-to-day operations of the EASSI-PC clinical trial and providing high-level administrative support.Key...


  • Gold Coast, Queensland, Australia Pharmiweb Full time

    Study Start Up Associate II Job DescriptionAt ICON, we're seeking a highly skilled Study Start Up Associate II to join our dynamic team. As a Study Start Up Associate II, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and...


  • Gold Coast, Queensland, Australia Pharmiweb Full time

    Key Responsibilities:As a Clinical Research Associate in our Vascular Devices team, you will be responsible for monitoring study progress, ensuring compliance with regulations, and developing policies and procedures. Additional Duties:Support clinical trial management systems, maintain trial master files, and manage study Investigators. Leverage your...


  • Gold Coast, Queensland, Australia Pharmiweb Full time

    Job SummaryWe are seeking an experienced Clinical Research Associate to join our team at Pharmiweb. As a Clinical Research Associate, you will be responsible for clinical monitoring activities, site relationships, and study site management in accordance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, and Protocol.Key Responsibilities:Develop strong...


  • Gold Coast, Queensland, Australia Pharmiweb Full time

    Clinical Research Associate Role SummaryThe successful candidate will join Pharmiweb, the world's largest clinical research organisation, to work on Oncology trials. They will collaborate with country operations teams and site personnel to ensure site activation and study timelines are met.Main Responsibilities:Perform Site Qualification VisitsBuild...


  • Gold Coast, Queensland, Australia Mediix Full time

    About the Role:We are seeking a dedicated Senior Staff Specialist or Staff Specialist (Psychiatrist) to join our team at Mediix, a leading healthcare provider in the region with a team of over 11,000 professionals committed to delivering world-class healthcare services.As a Senior Staff Specialist or Staff Specialist in Adult Psychiatry, you will provide...


  • Gold Coast, Queensland, Australia Mediix Full time

    A highly skilled Senior Staff Specialist is sought to provide expert clinical support to Mental Health and Specialist Services at Mediix, a leading healthcare provider on the Gold Coast.About the Role:This exciting opportunity involves working with a dedicated team of professionals committed to delivering world-class healthcare services. As a Senior Staff...


  • Gold Coast, Queensland, Australia Mediix Full time

    About the RoleAn exciting opportunity has arisen for a dedicated Senior Staff Specialist or Staff Specialist (Psychiatrist) to join Mediix, a leading healthcare provider in the Gold Coast region. As a Senior Staff Specialist or Staff Specialist in Adult Psychiatry, you will provide expert clinical support to Mental Health and Specialist Services.You will...


  • Gold Coast, Queensland, Australia Pharmiweb Full time

    Job SummaryWe are seeking a Senior Medical Director to provide leadership and direction to the Safety Medical Sciences business functions and other assigned business functions. The ideal candidate will have extensive experience in drug safety and clinical trials, as well as strong managerial and leadership skills.Responsibilities:Provide strategic inputs to...


  • Gold Coast, Queensland, Australia Pharmiweb Full time

    Hire a Senior Clinical Scientist to lead clinical/scientific execution of clinical protocol(s). Collaborate with medical monitoring, Clinical Research and Pharmacovigilance teams. Key responsibilities include designing CRFs, monitoring clinical data, and providing scientific mentorship. You will also assist with data analysis, presentation, and manuscript...


  • Gold Coast, Queensland, Australia Mediix Full time

    About the Role:Mediix, a leading healthcare provider, is seeking a dedicated Clinical Expert in Adult Psychiatry to join their team of over 11,000 professionals on the Gold Coast. This exciting opportunity allows you to provide expert clinical support to Mental Health and Specialist Services, fostering a culture of medical education and ensuring safe,...

  • Clinical Expert

    4 weeks ago


    Gold Coast, Queensland, Australia Mediix Full time

    About the Role:A senior medical professional is sought to provide expert clinical support to Mental Health and Specialist Services at Mediix, a leading healthcare provider. The successful candidate will be responsible for fostering a culture of medical education and ensuring safe, effective, patient-centered clinical practices.About the Organisation:Mediix...


  • Gold Coast, Queensland, Australia Mediix Full time

    About the RoleAn opportunity has arisen for a Senior Staff Specialist or Staff Specialist in Adult Psychiatry to join a leading healthcare provider in the region with a team of over 11,000 professionals.As a Senior Staff Specialist or Staff Specialist, you will provide expert clinical support to Mental Health and Specialist Services, fostering a culture of...


  • Gold Coast, Queensland, Australia JPS Medical Recruitment Full time

    Are you looking for a fulfilling career in psychiatry? JPS Medical Recruitment is seeking an experienced Clinical Psychiatric Specialist to join our esteemed Mental Health Service Group at a prestigious 900-bed tertiary teaching hospital. Located in one of Australia's leading lifestyle destinations, this position offers the perfect blend of professional...


  • Gold Coast, Queensland, Australia Bond University Full time

    About the PositionBond University's Institute for Evidence-Based Healthcare is seeking a dedicated and highly skilled Clinical Trial Coordinator to join our dynamic team. As Australia's first private University, we are committed to delivering world-class research, engagement, and training that serves as a national and international resource for scholars,...


  • Gold Coast, Queensland, Australia Healthscope Full time

    About this role:We are seeking a Clinical Nursing Specialist to join our team at Healthscope. This is a challenging and rewarding role that requires a high degree of autonomy and clinical expertise.Key responsibilities:Deliver safe, evidence-based nursing care to patientsSupervise and direct nursing team members to deliver patient careDevelop and implement...


  • Gold Coast, Queensland, Australia Anglicare Southern Queensland Full time

    About the Role:We are seeking a skilled Clinical Nurse Specialist to join our team in Southport, providing comprehensive and accurate nursing assessments, and planning care based on outcomes.You will be responsible for utilising contemporary evidence-based clinical knowledge and case management of clients. The ideal candidate will have strong clinical...


  • Gold Coast, Queensland, Australia Mediix Full time

    About the RoleWe are seeking a highly skilled Senior Staff Specialist or Staff Specialist to join our team of medical professionals at Mediix, a leading healthcare provider in the Gold Coast region. As a key member of our Mental Health and Specialist Services team, you will provide expert clinical support and foster a culture of medical education, ensuring...


  • Gold Coast, Queensland, Australia Healthscope Full time

    Job Description:At Healthscope, we are committed to delivering exceptional patient care and providing our staff with opportunities for growth and development. We are currently seeking a skilled Clinical Healthcare Specialist to join our team at Gold Coast Private Hospital.About the Role:This is an exciting opportunity for a dedicated and compassionate...


  • Gold Coast, Queensland, Australia Stryker Australia Pty Ltd Full time

    Stryker Australia Pty Ltd, a leading global medical device company, is seeking a highly motivated and skilled Mako Robotic Specialist to join their Joint Replacement team in Gold Coast, QLD.The successful candidate will be responsible for providing technical and clinical specialist expertise to customers, attending surgical procedures, and assisting surgeons...