Ethics and Regulatory Specialist

Nucleus Network; Melbourne; Hybrid; AUD 90,000 - 130,000; Full time

Benefits offered by this job

Flexible work options

Employee wellness initiatives

Professional growth opportunities

Employee recognition

Job summary

Nucleus Network is seeking an Ethics and Regulatory Specialist to ensure effective coordination of the ethics submission process for clinical trials. The role requires maintaining up-to-date regulatory knowledge and close collaboration with internal and external stakeholders.

Responsibilities include overseeing start-up activities, coordinating ethics submissions, and ensuring documentation accuracy across Project Teams. A life sciences degree and strong regulatory expertise are essential.

Qualifications

• Bachelor's degree in life sciences or related field.
• Strong written communication skills with technical writing experience (thesis or research papers) preferred.
• Comprehensive knowledge of ICH/GCP guidelines and applicable regulatory requirements.
• Excellent knowledge of HREC and IRB submission process and requirements.
• Effective time management and ability to meet deadlines.
• Ability to work independently and in a team.
• Attention to detail in essential document preparation.

Responsibilities

• Oversee start-up activities and act as the point of contact for ethics-related decisions and activities.
• Coordinate ethics submissions and amendments.
• Liaise with internal and external stakeholders for ethics matters.
• Maintain up-to-date knowledge of regulatory requirements and related documentation.
• Ensure all essential study documentation for ethics submissions and approvals is current for Project Teams.

Skills

Ethics submissions coordination

Regulatory knowledge

Technical writing

Time management

Independent work

Team collaboration

Education

Bachelor's degree in life sciences or related field

Tools

ICH/GCP guidelines

HREC/IRB processes

Job description

We are excited to announce an opportunity for an Ethics and Regulatory Specialist to join our dynamic team at Nucleus Network.

As the only global phase 1 clinical trials specialist with facilities in both the USA, UK and Australia, we are committed to “advancing medicine and improving lives” by attracting exceptional talent.

Since our founding in 2004, Nucleus Network has successfully conducted over 1500 phase 1 clinical trials for biotechnology and pharmaceutical companies from the USA, Europe, Australia, Japan, South Korea, Taiwan, and China.

Our organization is characterized by our core values, outstanding work culture, dedication to staff development, and commitment to providing an optimal work environment.

Join us on this exciting journey of growth and gain world-class experience working with some of the most innovative biotechnology and pharmaceutical companies globally.

About the role

TheEthics and Regulatory Specialistis responsible for ensuring effective coordination of the ethics submission process for clinical trials at Nucleus Network.

Key responsibilities

• Oversee start-up activities and be the point of contact for ethics-related decisions and activities
• Coordinate ethics submissions and amendments
• Liaise and build close working relationships with internal and external stakeholders
• Maintain up to date knowledge, ensuring adherence and compliance with local regulatory requirements and associated documentation
• Ensure all essential study documentation related to ethics submissions and approvals are kept up to date for wider Project Teams

Requirements

• Bachelor’s degree in life sciences or related field
• Exceptional written communication skills, specifically technical writing; (thesis or research papers) in an honours or Masters setting (desired)
• Comprehensive knowledge of ICH/GCP guidelines and all applicable regulatory requirements
• Excellent working knowledge of HREC and IRB submission process and requirements
• Effective time management skills and the ability to work to deadlines
• Able to work independently and effectively in a team
• An eye for detail to ensure accuracy in critical essential document preparation

Meaningful Impact

-'advancing medicine, improving lives'of people around the world

Professional Growth Opportunities -

We believe in investing in our employees' development

Employee Recognition -

Your hard work and achievements will be recognised and rewarded

Employee Wellness Initiatives -

We prioritize the health and wellbeing of our employee

Flexible work options –

hybrid/remote work arrangements are available

Our commitment to improving lives involves creating a supportive and inclusive space where every individual feels they can be their full selves. This policy applies to all aspects of employment within Nucleus Network including our hiring and selection process. We are an equal opportunity employer, making hiring decisions based on merit and business needs at the time. We want people who embody our values of drive, teamwork, customer focus and excellence.

At Nucleus Network, we recognize our responsibility to ensurethe safety of our staff, participants, and visitors. As such, Nucleus Network requires all employees to be vaccinated against COVID-19. Vaccination evidence must be provided before the commencement date.

For more information about Nucleus Network, go to nucleusnetwork.com.au.