Thermo Fisher Scientific
Senior/Principal - Country Approval Specialist
Remote, North Carolina, USA · Principal
Sponsorship not specifiedDetected 9 hours ago
ComplianceNegotiationUnityCRISPRResearchCommunicationCollaboration
About the role
- Thank you for your interest as you consider starting a new career journey with us.
- Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion.
- Please contact us to request accommodation.
Responsibilities
- Develop and implement local submission strategy. Provide technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
- Develop country specific Patient Information Sheet/Informed Consent form documents.
- 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
- Apply today to help us deliver tomorrow's breakthroughs.
- As the world leader in serving science, our colleagues develop critical solutions through innovation-and build rewarding careers.
- 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.
Requirements
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Knowledge, Skills, Abilities:
- Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations Why Join Us?
- For Principal Country Approval Specialist: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (5+ years direct startup experience in CRO/Sponsor setting or comparable to 8+ years relevant experience).
Skills
- 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
Compensation
- Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion.
Benefits
- 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.
Equal opportunity
- Thermo Fisher Scientific is an Equal Opportunity Employer.
Visa & Work Authorization
- rience that provides the knowledge, skills, and abilities to perform the job (2+ years direct startup experience in CRO/Sponsor setting or comparable to 5+ years relevant experience)
Apply directly at Thermo Fisher Scientific →Create a free account for alerts like thisView Thermo Fisher Scientific immigration profile
This listing is sourced directly from Thermo Fisher Scientific's careers page and normalized into a canonical job model.