Senior Country Approval Specialist / Principal Country Approval Specialist

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🔥 23 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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.

🎯 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 5-8 years) • 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 • Good judgment and decision-making skills • Basic medical/therapeutic area and medical terminology knowledge • Ability to work in a team environment or independently, with minimal supervision, as required • Ability to mentor fellow SIA team members in a positive and effective manner • Excellent team player with teambuilding skills • Basic organizational and planning skills • Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations

🏖️ Benefits

• Health insurance • 401(k) • Flexible work arrangements • Paid time off • Professional development