Country Approval Specialist - FSP

What You’ll Do

• 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.
• Audit and maintain site ICF approvals.
• Adapt country and site specific ICF changes for protocol and Investigator Brochure (IB) amendments as necessary.
• Carefully 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.
• 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 sponsor SOPs.
• Maintains knowledge of and understand PPD SOPs, sponsor SOPs/directives, and current regulatory guidelines as applicable to services provided.
• Complete handover document and provide to Site Manager at the appropriate point – which will be study dependent.
• Participate as required in Team Meetings.
• May be required to support activation readiness at the site level to ensure training completion, system access, and supplies are onsite.

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).

Knowledge, 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.