Senior Medical Writer – Client Aligned (FSP)

ThermoFisher Scientific; Polska; Hybrid; PLN 180,000 - 260,000; Full time

Job summary

Thermo Fisher Scientific is expanding its Medical Writing FSP team in Europe. We seek a Senior Medical Writer dedicated to a client in the FSP space, with experience in structured content and automation to support delivery.

You will develop high-quality clinical and regulatory documents meeting regulatory requirements and company standards. The role requires leading a team of medical writers, managing complex writing projects, and staying up-to-date with global guidelines and drug development

Qualifications

• Bachelor's degree in a scientific discipline or equivalent; advanced degree preferred.
• Regulatory writing experience comparable to 5+ years.
• Experience in pharmaceutical/CRO industry.
• Experience directing complex medical writing projects.
• EU CTR experience preferred.

Responsibilities

• Write and edit clinical and regulatory documents, including study reports, protocols, IBs and submissions.
• Collaborate with cross-functional teams to gather information and ensure accuracy.
• Ensure documents align with regulatory guidelines and company standards.
• Provide input on document content, structure, and presentation.
• Review and provide feedback on documents from others.
• Manage timelines and deliverables for projects.
• Mentor junior medical writers and ensure high-quality outputs.
• Stay current with industry trends and regulatory requirements.

Skills

Leadership

Regulatory knowledge

Project management

Communication

Quality control

Independent decision making

Self-motivated

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.