Senior/Principal - Country Approval Specialist
Job Title: Senior/Principal - Country Approval Specialist
Job Location: Remote, North Carolina, United States of America
Job Location Type: Remote
Job Contract Type: Full time
Job Seniority Level:
Environmental Conditions: Office
Work Schedule: Standard (Mon-Fri)
Work Schedule
Standard (Mon-Fri) Environmental Conditions
Office Job Description
Join Us as a Senior/Principal Country Approval Specialist - Make an Impact at the Forefront of Innovation
The Senior/Principal Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy.
What You'll Do:
• Prepare, review and coordinate local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Provide local regulatory strategy advice (MoH &/or EC) to internal clients.
• Develop and implement local submission strategy. Provide technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
• Serve as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner.
• Ensure guidelines and processes are followed for effective internal team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.
• Act as a key-contact at country level for all submission-related activities.
• Participate as required in Submission Team Meetings, Review Meetings and Project Team meetings.
• Coordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation.
• Achieve company’s target cycle times for site activations.
• Prepare the regulatory compliance review packages, as applicable.
• Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.
• Develop country specific Patient Information Sheet/Informed Consent form documents.
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• Assist in identifying and recognizing local out of scope activities in a contract in a timely manner and advise relevant functions.
• Support the coordination of feasibility activities, as required, in accordance with agreed timelines.
• Ensure that trial status information relating to SIA activities are accurately maintained in the database and is current at all times.
• Oversee country study files and ensure that that they meet PPD WPD’s or client SOP’s.
• Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• Direct/mento other SIA individuals assigned to support projects of responsibility, as appropriate
• Proactively identify issues or anomalies in the regulatory process of a study, resolve or escalate as appropriate.
Education & Experience Requirements:
For Senior Country Approval Specialist:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (2+ years direct startup experience in CRO/Sponsor setting or comparable to 5+ years relevant experience).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
For Principal Country Approval Specialist:
• Bachelor's degree or equivalent and relevant forma