Specialist, Regulatory & Site Activation - Australia - Remote

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

Our Regulatory Affairs team boasts practical knowledge in the North American and International regulatory arenas through all phases of the drug-development process. We hold extensive industry experience shaping project plans to meet diverse regulatory requirements. Our experts strategize the most efficient route for our clients’ products, from bioanalytical study requirements, pre-IND/pre-NDA meetings with the FDA, and applications to Competent Authorities and Ethics Committees, to successful marketing applications, while providing the necessary guidance to ensure continual regulatory compliance.

What you will do

• Liaise with SAR colleagues to drive plan, organize, compile, progress, track, and submit regulatory submissions on a timely basis and with a consistently high level of quality.

• May act as a contact point for translation review of submission documents such as applications, synopses, ICFs, labels, etc.

• Maintain country-specific patient information sheet and consent form customization text, Maintain country-specific drug labeling information and Country Intelligence Pages

• Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country-specific requirements.

What you will bring to the role

• Organizational and time management skills

• Aptitude for planning, strategizing, managing, monitoring, scheduling, and critiquing skills

• Strong written and verbal communication skills to clearly and concisely present information in English and local language both

• Strong ability to handle multiple tasks in a fast-paced and changing environment

• Proficiency in MS Office applications, including Microsoft Word, Excel, and PowerPoint

• Strong understanding of country-level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.

Your experience

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related sciences

• Minimum three years of experience in clinical research, preferably in site activation and/or regulatory-related function

• Previous experience within the pharmaceutical/CRO industry.

• Thorough knowledge of ICH GCP, EU Clinical Trials Directive, and other relevant guidance on conducting clinical research.

• Experience in regulatory submissions in Australia

• Multilingualism preferred; working knowledge of English.

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

Originally posted on Himalayas