Thermo Fisher Scientific is seeking a Regulatory Affairs Specialist to join their PPD® clinical research services team. This position supports the preparation of regulatory documentation, ensuring compliance and facilitating the delivery of client projects within clinical research services. The role is key to advancing drug development and bringing innovative therapies to market.
Key Responsibilities:
- Documentation & Compliance: Assist with the preparation of documentation and submissions, coordinating deliverables to meet regulatory requirements.
- Client Interaction: Liaise with clients to provide updates on project plans and support their needs.
- Project Support: Help with project timelines, budgeting, and forecasting.
- Knowledge Maintenance: Stay informed about SOPs, client directives, and current regulatory guidelines.
- Business Development: Support the department’s business development and project pricing.
- Team Collaboration: Work with project teams and management to resolve issues and ensure project delivery.
- Quality Assurance: Maintain high standards for the accuracy and quality of documents.
Qualifications:
- Education: Bachelor’s degree or equivalent qualification.
- Experience: Minimum of 2+ years of relevant experience.
- Skills & Abilities:
- Strong English communication skills, both written and oral.
- Detail-oriented with strong editorial/proofreading skills.
- Proficient in Microsoft Office Suite and adaptable to new technologies.
- Solid organizational and time-management skills for handling multiple projects.
- Basic knowledge of global and national regulatory procedures for clinical trials.
- Familiarity with medical terminology and statistical concepts.
- Good analytical and problem-solving skills.
- Ability to work independently while following direction.
Keys to Success:
- Effective team collaboration.
- Proactive approach to project management and problem-solving.
- Commitment to quality and regulatory compliance.
