Senior Medical Writer – Client Aligned (FSP)

ThermoFisher Scientific; Italia; Remote; EUR 65,000 - 90,000; Full time

Job summary

Thermo Fisher Scientific is expanding its Medical Writing FSP team in Europe. We seek a Senior Medical Writer to develop high-quality clinical and regulatory documents, ensuring regulatory compliance and company standards.

The role involves writing and editing documents, collaborating with cross-functional teams, and mentoring junior writers while staying up-to-date with industry guidelines and regulatory requirements.

Qualifications

• Bachelor's degree in a scientific discipline is required.
• Regulatory writing experience with pharma/CRO background is expected.
• Advanced degree is a plus and preferred.

Responsibilities

• Write and edit clinical and regulatory documents including CSRs, protocols, IBs, and submissions.
• Collaborate with cross-functional teams to ensure accuracy and completeness of documents.
• Ensure documents align with regulatory guidelines and company standards.

Skills

Leadership

Organizational skills

Regulatory knowledge

Communication

Quality control

Independent decision making

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Summarized Purpose:

We are excited to be expanding our Medical Writing FSP Team in Europe. We are looking for a SMW 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.
• Mentor and provide oversight to junior medical writers and ensure high-quality deliverables
• Stay current with industry trends, guidelines, and regulatory requirements.

Education and Experience:

• Bachelor's degree in a scientific discipline 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.

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.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.