Medical Writer – Client Aligned

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🔥 4 minutes ago

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Write and edit clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions • Collaborate with cross-functional teams to gather necessary information and ensure document accuracy and completeness • Ensure documents align with regulatory guidelines, company standards, and industry best practices • Manage timelines and deliverables for assigned projects • Stay current with industry trends, guidelines, and regulatory requirements • Support delivery through Structured Content Authoring systems and automation

🎯 Requirements

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification required • 3+ years of regulatory writing experience • Experience working in the pharmaceutical/CRO industry required • Experience in Structured Content Authoring systems and automation preferred • Advanced degree preferred • EU CTR experience preferred • Excellent organizational and program management skills • Extensive knowledge of regulatory guidelines and drug development processes • Strong interpersonal and communication skills • Understanding of quality control processes and regulatory compliance • Self-motivated and adaptable • Excellent judgment and a high degree of independence in decision making and problem solving

🏖️ Benefits

• Award-winning learning and development programme • Competitive salary • Extensive benefits package focused on employee health and well-being • Flexible working culture • Work-life balance • Collaborative environment • Opportunities to share expertise and work with global colleagues

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