Senior Medical Writer EMEA at Thermo Fisher Scientific

Summarized Purpose: 

• We are excited to be expanding our Medical Writing FSP Team in Europe. We are looking for a PMW to be dedicated to a client in the FSP space; experience in Structured Content Authoring systems and automation to support delivery would be preferred. We are seeking a talented and experienced Senior Medical Writer to join our team. The Senior Medical Writer will be responsible for developing high-quality clinical and regulatory documents, ensuring they meet all regulatory requirements and company standards.

Key Responsibilities:

• 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 the accuracy and completeness of documents.
• Ensure documents align with regulatory guidelines, company standards, and industry best practices.
• Provide input on document content, structure, and presentation.
• Review and provide feedback on documents prepared by other team members.
• Manage timelines and deliverables for assigned projects.
• Stay current with industry trends, guidelines, and regulatory requirements.

Education and Experience: 

• Bachelor's degree in a scientific field or equivalent and relevant formal academic / vocational qualification required; Advanced degree preferred. 
• Regulatory writing experience that provides the knowledge, skills, and abilities to perform the role (comparable to 5+ years). 
• Experience working in the pharmaceutical/CRO industry required. 
• Experience in managing and directing complex medical writing projects required.
• EU CTR experience preferred.
• Experience working on structured content management system and AI-driven content creation, and familiarity with Natural Language Generation preferred.  

Knowledge, Skills, and Abilities: 

• Excellent organizational and program management skills 
• Proven leadership skills to manage and mentor a team of medical writers.
• Extensive knowledge of regulatory guidelines and drug development processes
• Strong interpersonal and communication skills to build and maintain effective working relationships with colleagues and stakeholders 
• Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards
• Self-motivated and adaptable 
• Excellent judgment; high degree of independence in decision making and problem solving