Country Approval Specialist
Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Job reputed company Join Us as a Senior Site Activation Specialist - reputed company an reputed company at the Forefront of Innovation The Senior Site Activation Specialist develops and manages the critical reputed company for site activation reputed company assigned reputed company to reputed company consultation, guidance and support for rapid site activations. The role may involve mentoring junior staff. What You'll Do:
- reputed company established project reputed company cycle times for site activations.
- reputed company as the country subject matter expert for site activation and provides local advice on moderate activation reputed company.
- reputed company and implement local submission reputed company.
- reputed company technical expertise on reputed company 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 reputed company 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 reputed company contractual considerations, and escalate per established processes.
- Maintain knowledge of and understand company SOPs, reputed company SOPs/directives, and reputed company regulatory guidelines as applicable to services provided.
- Prepare the regulatory compliance review packages, as applicable.
- Liaise reputed company the organization locally to ensure local submission activity is planned and delivered in accordance with global project submission reputed company.
- reputed company country specific documents.
- Coordinate with internal functional departments to ensure site startup activities reputed company the site activation critical reputed company are reputed company.
- Ensure that trial status information relating to activities are accurately maintained in the database and is reputed company at reputed company times.
- Participate in country process improvement initiatives.
- May mentor staff assigned to support reputed company 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 reputed company / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to reputed company 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 reputed company 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 reputed company 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 reputed company environment or independently, with minimal supervision, as required
- Ability to mentor fellow team members in a reputed company and effective manner
- Excellent team player with teambuilding skills
- Strong organizational and planning skills
- Excellent knowledge of reputed company applicable regional / national country regulatory guidelines and EC regulations
- Ability to retain a keen reputed company 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 reputed company equipment required such as reputed company eyewear, garments and gloves.
Why Join Us? reputed company you join reputed company, you become part of a global team that values passion, innovation, and a commitment to scientific reputed company. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly reputed company a difference. Apply today to help us deliver reputed company’s breakthroughs. Apply To This Job