Country Approval Specialist

Work Schedule Standard (Mon-Fri) Environmental Conditions Office

Job Description

Join Us as a Senior Site Activation Specialist - Make an Impact at the Forefront of Innovation The Senior Site Activation Specialist develops and manages the critical path for site activation within assigned projects to provide consultation, guidance and support for rapid site activations. The role may involve mentoring junior staff. What You'll Do:

• Achieve established project target cycle times for site activations.
• Act as the country subject matter expert for site activation and provides local advice on moderate activation strategy.
• Develop and implement local submission strategy.
• Provide technical expertise on projects on collaboration with relevant internal departments.
• Negotiate and finalize site agreements, budgets, required forms and essential documents with study sites in accordance with local/accepted process.
• Ensure compliance to established negotiation parameters, authority approval, contractual process and client expectations as developed and approved.
• Ensure compliance of budgetary guidance, templates and process.
• Identify and assess legal, financial and operational risks in accordance with Thermo Fisher and client contractual considerations, and escalate per established processes.
• Maintain knowledge of and understand company SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• Prepare the regulatory compliance review packages, as applicable.
• Liaise within the organization locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.
• Develop country specific documents.
• Coordinate with internal functional departments to ensure site startup activities within the site activation critical path are aligned.
• Ensure that trial status information relating to activities are accurately maintained in the database and is current at all times.
• Participate in country process improvement initiatives.
• May mentor staff assigned to support projects of responsibility, as appropriate.
• Prepare and maintain country master document templates and other regulatory intelligence systems, as required.

Education & 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 5+ years’) or equivalent combination of education, training, & 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. Knowledge, Skills, Abilities:

• Highly effective oral and written communication skills
• Excellent interpersonal skills
• Ability to apply strong attention to detail and produce quality of documentation
• Strong negotiation skills
• Good computer skills and the ability to learn appropriate software
• Comprehensive English language and grammar skills
• Firm judgment and decision-making skills
• Good 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 team members in a positive and effective manner
• Excellent team player with teambuilding skills
• Strong organizational and planning skills
• Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations
• Ability to retain a keen sense of urgency
• Ability to multitask in a fast paced environment.

Working Conditions and Environment:

• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves.

Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs. Apply To This Job