Medical Writer (FSP) - Client Aligned

ThermoFisher Scientific; Portugal; Teletrabalho; EUR 45 000 - 75 000; Tempo integral

Resumo da oferta

Thermo Fisher Scientific is expanding its Medical Writing FSP Team in Europe. We are seeking a Medical Writer to develop high-quality clinical and regulatory documents, ensuring they meet regulatory requirements and company standards.

You will write and edit documents such as clinical study reports, protocols, investigator brochures, and regulatory submissions, collaborating with cross-functional teams to gather information and ensure accuracy.

Qualificações

• Bachelor's degree in a scientific discipline or equivalent; advanced degree preferred.
• Regulatory writing experience (≈3+ years) in pharma/CRO.
• Experience in the pharmaceutical/CRO industry required.
• EU CTR experience preferred.

Responsabilidades

• Write and edit clinical and regulatory documents (e.g., study reports, protocols, ICs, submissions).
• Collaborate with cross-functional teams to gather information and ensure accuracy.
• Ensure documents align with regulatory guidelines and company standards.
• Manage timelines and deliverables for assigned projects.
• Stay current with industry guidelines and regulatory requirements.

Conhecimentos

Regulatory writing

Cross-functional collaboration

Regulatory guidelines

Communication skills

Quality control

Independence

Formação académica

Bachelor's degree in science

3+ years regulatory writing experience

Advanced degree preferred

Ferramentas

Structured Content Authoring

Automation experience

Descrição da oferta de emprego

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 MW 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 Medical Writer to join our team who 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.

• 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 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 3+ years).

• Experience working in the pharmaceutical/CRO industry required.

• EU CTR experience preferred.

Knowledge, Skills, and Abilities:

• Excellent organizational and program management skills.

• 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.

What We Offer:

At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme (https://www.ppdi.com/careers/about#Training) , ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture (https://www.ppdi.com/careers/life-at-ppd) , where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.