Trial Activation Approval Specialist II | myGwork | Kenya Full Time

Responsibilities

• Prepares and coordinates regulatory submissions.
• Provides local regulatory strategy advice to internal clients.
• Develops and implements local submission strategy.
• Serves as primary contact for investigators and authorities.
• Ensures guidelines are followed for effective communications.
• Acts as a key contact for submission-related activities.
• Participates in Submission Team and Project Team meetings.
• Coordinates with departments for site start-up activities.
• Achieves target cycle times for site activations.
• Prepares regulatory compliance review packages.
• Liaises locally for submission activity planning.
• Develops country-specific Patient Information Sheet documents.
• Assists with grant budgets and payment schedule negotiations.
• Identifies local out of scope activities in contracts.
• Supports coordination of feasibility activities as required.
• Maintains accurate trial status information in the database.
• Oversees country study files for compliance.
• Maintains knowledge of PPD and Client SOPs and guidelines.
• Directs and mentors other SIA individuals on projects.
• Identifies and resolves regulatory process issues.

Requirements

• Relevant experience in regulatory submissions.
• Knowledge of local regulatory guidelines.
• Strong communication and coordination skills.
• Ability to manage timelines and submissions effectively.
• Experience with patient information and consent documents.

Benefits

• Opportunity to work with an inclusive employer.
• Be part of a global organization with a meaningful mission.
• Collaborative team environment focused on innovation.