Specialist, Regulatory Compliance

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!

What  Specialist, Regulatory Compliance do at Worldwide

The Specialist, Regulatory Compliance is a global position responsible for performing quality review and approval of essential documents in compliance with the relevant Standard Operating Procedures, country regulations, and industry best practice prior to initiation of study sites.

What you will do

Tasks may include but are not limited to:
Receive, review, process and file essential documents, part of the Essential Document (ED) package agreed for the study, in accordance with applicable local regulations, internal SOPs and guidelines and ED Review Plan.
Check the completeness of the ED packages as well as the quality of the documents provided
Communicate corrective action and ensure issue resolution to meet documentation requirements as required, prior to approval of the ED packages and ED checklist sign off.
Complete/updated relevant tracking tool on ongoing basis to allow visibility to project teams on the ED review progress status.
Prepare and submits electronic copies of approved site ED, part of the ED Package for filing in Trial Master File, as applicable.
Work with a variety of Electronic Document Management Systems to review and approve ED, as needed.
Escalate any quality issues in a timely manner to relevant parties.
Perform additional tasks as assigned by their Line Manager.
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

What you will bring to the role

Advanced written and spoken English.
Strong organizational and time management skills
Exercise sound judgment and ability to identify decisions requiring supervisory approval
Handle multiple tasks with exceptional accuracy
Computer literacy in Microsoft Word and Excel.

Your experience

University degree preferred (Life Science desirable) and 1 year of relevant experience or Combination of education and 1 year of relevant experience.

Promotion to the next level is not automatic based on years of experience. Personnel is evaluated on proven competency, level of responsibility, and ability to work independently.

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.