Country Approval Specialist - FSP

Work Schedule

Environmental Conditions

Job Description

Summary of Essential Functions:

The primary responsibilities include coordinating and managing local regulatory and ethics submissions in alignment with global strategies, providing regulatory strategy advice and technical expertise, and serving as the primary contact for investigators, ethics committees (EC), and regulatory authorities (RA). The role ensures effective communication and timely management of submissions, supports and manages Informed Consent Form (ICF) negotiations and approvals, and achieves set cycle times for site activations while maintaining accurate trial status information.

Key responsibilities:

• Prepare, review, and coordinate local regulatory submissions (EC, additional special national local applications if applicable, e.g. therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy for the initial application and amendments as necessary.
• Provide local regulatory strategy advice (RA &/or EC) to key stakeholders.

• Provide local submission strategy for their country in consultation with regional oversight lead and key team members. 
• Provide technical expertise and coordination oversight for study in collaboration with relevant stakeholders.
• Serve as primary contact for investigators and with the local regulatory authorities and ethics committees (in collaboration with their People Manager for complex issues) to ensure submissions are managed in a timely manner.
• Serve as a key contact at the country level for submission-related activities and ensure guidelines and processes are followed for effective communications with study teams, investigators, and RAs and ECs to ensure submissions are managed in a timely manner.
• May identify issues or anomalies in the regulatory process of a study and escalate as appropriate.
• May support country specific Informed Consent Form (ICF) negotiations with EC/IRB or RA and raise any country-level ICF risks to Informed Consent Manager (ICM) and study leadership.
• Develop site-specific ICFs manage ICF negotiations with EC/IRB, and document site ICF approvals.
• Adapt country and site specific ICF changes for protocol and Investigator Brochure (IB) amendments as necessary.
• Participate as required in Team Meetings.
• Coordinate with key stakeholders 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.
• Align with the site on the critical start-up path upon site selection and take accountability for maintaining accurate tracking of the site’s critical path throughout the start-up phase.
• Achieve set baseline cycle times for site activation.
• Responsible for Essential Documents (ED) creation, collection and QC. 
• May prepare Essential Document Packs (EDPs).
• If required for the study, support the coordination of feasibility activities, in accordance with agreed timelines.
• Ensure that trial status information relating to start-up activities is accurately maintained in the database and is always current.
• Ensure current investigator and site staff contact details are appropriately maintained in systems.
• Ensure TMF is current for country and sites according to client SOPs.
• Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• May be required to support activation readiness at the site level to ensure training completion, system access, and supplies are onsite.
• Complete handover document and provide to Site Manager at the appropriate point – which will be study dependent.

Education and Experience Requirements:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
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.

Skills and Abilities:

• Effective oral and written communication skills
• Excellent interpersonal skills
• Strong attention to detail and quality of documentation
• Good negotiation skills
• Good computer skills and the ability to learn appropriate software
• Good English language and grammar skills
• Basic medical/therapeutic area and medical terminology knowledge
• Ability to work in a team environment or independently, under direction, as required
• Basic organizational and planning skills
• Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations.