Senior Country Approval Specialist

🕒 il y a 1 mois

🌲 North Carolina – Distant

🌲 North Carolina – Remote

⏰ Temps Plein

🟠 Senior

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 13%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Thermo Fisher Scientific

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1956

🏥 Santé

📦 Logistique

🏭 Fabrication

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific est le leader mondial dans le service aux sciences, avec un chiffre d'affaires annuel de plus de 40 milliards de dollars. Leur mission est de permettre à leurs clients de rendre le monde plus sain, plus propre et plus sûr en soutenant la recherche en sciences de la vie, en résolvant des défis analytiques complexes, en augmentant la productivité des laboratoires et en améliorant la santé des patients grâce aux diagnostics et au développement de thérapies révolutionnaires. Avec une équipe mondiale, ils offrent des technologies innovantes et des services pharmaceutiques à travers des marques telles que Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon et PPD.

Description

• Prepare, review and coordinate local regulatory submissions in alignment with global submission strategy • Provide local regulatory strategy advice to internal clients • Develop and implement local submission strategy and provide technical expertise and coordination oversight • Serve as primary contact for investigators and local regulatory authorities • Ensure guidelines and processes are followed for internal, investigator and regulatory-authority communications • Act as key country-level contact for submission-related activities • Participate in submission, review and project team meetings • Coordinate site start-up activities with internal functional departments and align submission timelines with site activation critical paths • Achieve company target cycle times for site activations • Prepare regulatory compliance review packages • Coordinate local submission activity in accordance with global project submission strategy • Develop country-specific Patient Information Sheet/Informed Consent documents • Assist with grant budgets and payment schedule negotiations with sites • Identify local out-of-scope contract activities and advise relevant functions • Support feasibility activities • Maintain accurate and current trial status information in the database • Oversee country study files and ensure compliance with PPD WPD or client SOPs • Maintain knowledge of PPD SOPs, client SOPs/directives and current regulatory guidelines • Direct or mentor SIA individuals assigned to projects • Identify, resolve or escalate regulatory-process issues and anomalies

🎯 Exigences

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job • Equivalent combinations of appropriate education, training and/or directly related experience may be considered • Effective oral and written communication skills • Excellent interpersonal skills • Strong attention to detail and quality of documentation • Good negotiation skills • Good computer skills and 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 • Ability to mentor fellow SIA team members • Excellent team player with teambuilding skills • Basic organizational and planning skills • Excellent knowledge of applicable regional/national country regulatory guidelines and EC regulations • Ability to work in an office/laboratory and/or clinical environment • Ability to use required personal protective equipment, including protective eyewear, garments and gloves

🏖️ Avantages

• Collaboration and development opportunities • Passion, innovation, and commitment to scientific excellence • Work in a global team environment