Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Principal Medical Writer – Client Embedded (FSP)
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 Central and Eastern Europe. We are seeking a talented and experienced Principal Medical Writer with at least 8 years’ experience in regulatory writing to join our team. This is a remote role dedicated to a particular client in the FSP space. The successful applicant will be responsible for developing high-quality complex clinical and regulatory documents from planning and coordination through to final delivery, ensuring they meet all regulatory requirements and company standards. They will collaborate with internal and external teams, supporting and enabling effective and efficient communication that results in operational excellence.
Key Responsibilities:
Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies.
May serve as primary author who writes and provides input on complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
Provides senior level review of routine and complex documents. Provides training and mentorship for other writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
Ensures compliance with quality processes and requirements for assigned documents. As the subject matter expert, develops and reviews best practices, methods and techniques for achieving optimal results, including various client-specific processes, and leads process improvement initiatives.
May serve as backup program manager. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications, and assisting business development with client presentations and proposal text review, and attending bid defense meetings and capabilities presentations.
Represents the department at project launch meetings, review meetings, and project team meetings.
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 in managing and directing complex medical writing projects required.
Experience working in the pharmaceutical/CRO industry required.
Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous.
Knowledge, Skills, and Abilities:
Significant knowledge of global, regional, national and other document development guidelines
In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc.
Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
Excellent project management skills
Advanced interpersonal, oral and written communication, and presentation skills
Excellent negotiation…