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 Senior Specialist, Regulatory Compliance Do At Worldwide
The Senior 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. The Senior Specialist will assist in delivery of project timelines related to essential documents approval
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What You Will Do
- Assume the functional role of the global Regulatory Compliance Lead for assigned projects, providing project team representation for the division.
- Develop Essential Document Review Plan (EDRP), Essential Document Review Requirements (EDRF), customize country Essential Document (ED) checklists project ED templates for use by the site activation or clinical operations team, as applicable
- Provides instruction/training to sponsor/CRO personnel on policies and procedures related to essential document collection and maintenance.
- Oversee and ensure Essential Document package review and approval for the project is in accordance with the relevant Standard Operating Procedures, Working Instructions, EDRP and EDRF.
- Receive, review, process and file essential documents, part of the Essential Document package agreed for the project, in accordance with applicable local regulations, internal SOPs and guidelines and EDRP.
What You Will Bring To The Role
- Excellent organizational and time management skills
- Strong planning, monitoring scheduling and critiquing skills.
- Good interpersonal skills, with ability to clearly and concisely present information
- Ability to exercise sound judgment and ability to identify decisions requiring supervisory approval
- Excellent spoken and written English language skills. Proven cross-functional team leadership skills and the ability to influence others at all levels of an organization.
Your Experience
- University degree preferred (Life Science desirable) and 3 years of relevant experience (1 year in similar role/position) or Combination of education and 4 years of similar role/position (2 years of similar role/position) A bachelor’s degree in a technical field.
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
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