FSP Principal Medical Writer – EMEA (Remote)
Location: Remote, EMEA
Job Type: Full-time
Category: Clinical Research / Medical Writing
Experience Required: 8+ years
Job ID: R-01333780
Overview
Thermo Fisher Scientific is a global leader in clinical research services, dedicated to advancing science and delivering life-changing therapies. Our PPD® clinical research portfolio supports clinical trials in over 100 countries, spanning laboratory, digital, and decentralized clinical trial services. We are seeking a Principal Medical Writer to join our FSP Medical Writing team in EMEA. This fully remote role offers the opportunity to work with cutting-edge research programs and collaborate with global clients in the pharmaceutical and biotech industries.
As a Principal Medical Writer, you will be responsible for producing high-quality regulatory and scientific documentation, mentoring junior writers, and ensuring compliance with global standards and client-specific requirements. This role is ideal for candidates with experience in therapeutic areas such as Neurology, Immunology, Oncology, or Vaccines, although these are not mandatory.
Key Responsibilities
Lead and deliver complex clinical and regulatory documents including clinical study reports (CSR), study protocols, Investigator Brochures (IBs), INDs, and MAAs.
Serve as primary author for program-level documents and provide senior-level review of team deliverables.
Mentor and guide junior writers and program managers on document development strategy, regulatory compliance, and best practices.
Ensure compliance with internal quality standards, regulatory guidelines, and client-specific requirements.
Develop and implement performance metrics, process improvements, and document workflows to optimize quality and efficiency.
Represent the medical writing department in project meetings, review sessions, and client discussions.
Collaborate with internal and external stakeholders to facilitate smooth communication and operational excellence.
Qualifications
Bachelor’s degree in a scientific discipline required; Advanced degree (MSc/PhD) preferred.
Minimum 8 years of regulatory medical writing experience, including management of complex medical writing projects.
Prior experience in the pharmaceutical or CRO industry is highly preferred.
Experience with submissions documents (e.g., INDs, NDAs, MAAs) advantageous.
Therapeutic area expertise in Neurosciences is a plus.
Additional certifications in medical writing such as AMWA, EMWA, or RAC are advantageous.
Skills & Competencies
Strong knowledge of global, regional, and national regulatory document guidelines.
Expertise in preclinical, clinical, regulatory, and submissions documentation.
Exceptional writing, editorial, proofreading, and data interpretation skills.
Advanced project management and organizational skills.
Excellent interpersonal, communication, and presentation skills.
Strong decision-making, problem-solving, and negotiation skills.
Ability to mentor, guide, and lead junior medical writers.
High degree of independence and professional judgment in managing complex projects.
Why Join Thermo Fisher Scientific
Remote Work Flexibility: Fully remote position within the EMEA region.
Career Growth: Access to award-winning learning and development programs to advance your career.
Collaborative Culture: Join a global organization that values teamwork, knowledge sharing, and innovation.
Competitive Compensation: Comprehensive salary package, benefits, and work-life balance initiatives.
Global Impact: Contribute to clinical research that improves patient health worldwide.
At Thermo Fisher Scientific, we are committed to fostering a diverse and inclusive workplace where all perspectives are valued. Join our team and help drive innovation, deliver quality research, and make a meaningful impact in the healthcare industry.
#StartYourStory with PPD, part of Thermo Fisher Scientific
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