Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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 Principal Medical Writer to be dedicated to a client in the FSP space; experience in leading submissions would be preferred. We are seeking an experienced and highly skilled Regulatory Medical Writer to join our team. The role is be responsible for creating, reviewing, and managing a wide range of clinical and regulatory documents. This role requires a strong understanding of scientific concepts, exceptional writing skills, and the ability to communicate complex information clearly and concisely.
Key Responsibilities:
- Lead the development, writing, and editing of complex clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions (e.g., INDs, NDAs, MAAs).
- Collaborate with cross-functional teams, including clinical development, regulatory affairs, biostatistics, and medical affairs, to ensure the accurate and timely completion of documents.
- Ensure documents align with regulatory guidelines, company standards, and industry best practices.
- Provide strategic input and guidance on document content, structure, and presentation.
- Mentor and provide oversight to junior medical writers and ensure high-quality deliverables.
- Manage multiple writing projects simultaneously and prioritize tasks effectively.
- 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 8+ 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
- Capable of mentoring and leading junior level staff
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, 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, 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.
