- Junior
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!
*SUMMARY: The Assistant, Regulatory Affairs provides general and project specific administrative support to Regulatory Affairs.* *RESPONSIBILITIES:*_Tasks may include but are not limited to:_ If applicable, under the direction of a senior member of the department, coordinate & manage compilation of regulatory & ethics committee submissions throughout EU, CIS, Asia Pacific and Latin America regions Assist with the coordination of translation of regulatory correspondence and submission documents such as protocols, synopsis, ICF and labels Pack and dispatch regulatory submissions and site documents, follow up for delivery confirmation, obtain and file acknowledgement receipts and update relevant tracking tools Perform administrative QC of regulatory submissions, site documents to ensure correct completeness and formatting Liaise with Finance requesting fee payment to Regulatory Authorities Closely monitor the SM_RA_Subm inbox to match e-mail to the correct team members for prompt action Ensure department specific study files are submitted to Central Records and are consistently audit ready Prepare and submits hardcopies or electronic copies of Regulatory documents for storage at Central Records Provide relevant administrative training and support to junior staff Manage third party vendors such as printing, courier and translation service providers Provide general administrative assistance for the smooth running of the department – organize meetings and record minutes, manage diaries, assist with process improvement initiatives 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. *OTHER SKILLS AND ABILITIES*: Proven organizational and time management skills are essential attributes Excellent written and verbal communication skills to clearly and concisely present information Good interpersonal skills in a fast-paced, deadline oriented, and changing environment Excellent ability to handle multiple tasks Ability to exercise independent judgment with sensitivity to decisions requiring supervisory approval Excellent self-motivation skills Willingness to adapt to new procedural requirements Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint *REQUIREMENTS*: 2 years office/business experience in a supporting role Preferable CRO/pharmaceutical industry experience. Bachelor’s degree or equivalent preferredPromotion to the next level is not automatic based on years of experience. Personnel are 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.
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