Specialist, Regulatory and Site Activation - Mexico- Remote

Worldwide Clinical Research S. de R.L. de C.V.; México; A distancia; MXN 1,119,000 - 1,494,000; Jornada completa

Descripción de la vacante

A leading global CRO is seeking a Specialist in Regulatory and Site Activation for a remote position in Mexico. The ideal candidate will have a four-year degree, expertise in clinical research, and strong organizational skills. Responsibilities include driving regulatory submissions, maintaining documentation, and collaborating with local investigators. Join a diverse team committed to improving lives through innovative healthcare solutions.

Formación

• Minimum two years of experience in clinical research, preferably in site activation.
• Previous experience within the pharmaceutical/CRO industry.
• Thorough knowledge of ICH GCP, EU Clinical Trials Directive.

Responsabilidades

• Drive regulatory submissions on time with quality.
• Act as a contact point for translation review.
• Maintain country-specific documentation.

Conocimientos

Organizational skills

Time management

Written communication in English

Verbal communication in local language

Multi-tasking

Educación

Four-year degree in medical, biological, or related fields

Herramientas

MS Office (Word, Excel, PowerPoint)

Descripción del empleo

Specialist, Regulatory and Site Activation - Mexico- Remote page is loaded

Specialist, Regulatory and Site Activation - Mexico- Remote

Apply remote type Remote locations Virtual Mexico Virtual Chile time type Full time posted on Posted 6 Days Ago job requisition id JR101242

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 Regulatory Affairs Department does at Worldwide

O ur 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’ product s , 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 science

• Minimum two 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 clinical research conduct guidance.

• Multilingualism preferred; fluent in local language; 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’reon a mission to hire thevery bestand 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.

About Us

This is who we are.

We’re a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever.

We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special.

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