Sr 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 regulatory knowledge/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
• Strong critical thinking ability, Agility

• 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.

Welcome

Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell?

About Us

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Accessibility/Disability Access

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

EEO

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.