Specialist, Regulatory & Site Activation ( Remote)

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.

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!

Subject matter expert and local point of contact for activities supporting Regulatory submissions, site activation, and maintenance for awarded projects. Responsible for planning, initiating, and tracking documents required for regulatory submissions, essential document collection, review and provision of country/site/EC requirements to support achievement of site activation goals and communicating status, risks, and actions related to any start-up activities and maintenance when applicable.

_Tasks may include but are not limited to:
Responsible for supporting end-to-end site start-up from site identification to site activation and maintenance serving as the primary point of contact for the site
Act as internal primary point of contact at country level for regulatory and site activation activities in the assigned studies
Responsible for customization of country specific patient information sheet, informed consent form, labels and local regulatory documents to comply with ICH GCP & country specific requirements
Review and provide advice on country timelines for the assigned studies
Effectively communicate to the Regulatory Affairs Manager (RAM) and relevant project team members the status and action plans concerning submissions
Collect, receive, and perform first review of required study-specific site regulatory/essential documents in accordance with applicable SOPs, guidelines and relevant study specific plans.
Track study-specific regulatory documents by site and/or country and follows up with sites or internal team members as needed and reports to the RAM
Proactively identify risks and generate mitigation strategies at country/site level
Advise the RAM/project team about appropriate country regulatory strategies
Maintain regular communication with sites to ensure timely completion of start-up and maintenance activities
Provide timely and relevant updates of changing regulatory requirements, support on interpretation of new regulations, and maintain regulatory intelligence database for the assigned country
Be familiar with and comply with SOPs, ICH GCP and applicable regulations
Where required provide local QC of submission dossiers prior to dispatch
May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc.

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.

Strong organizational and management skills
Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills.
Self-motivated learning about current regulatory processes and intelligence
Excellent written and verbal communication skills to clearly and concisely present information
Proactive by identifying potential issues in the process and anticipating solutions
Thorough understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel
Easily adjusts to a changing environment; ability to prioritize adapt between detailed and strategic activities while maintaining delivery timelines and quality
Team-oriented work style; seeks and gives guidance to others
Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
Excellent ability to handle multiple tasks in a fast-paced and changing environment
Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
Aptitude for contemporary digital systems is helpful