Principal Medical Writer (EMEA) - client-embedded

at  Thermo Fisher Scientific

EDUCATION AND EXPERIENCE:

Bachelor’s degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
Experience in managing and directing complex medical writing projects required
Experience working in the pharmaceutical/CRO industry preferred
Submissions document experience advantageous
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 skills
• Excellent judgment; high degree of independence in decision making and problem solving
• Ability to mentor and lead junior level staff.

SUMMARIZED PURPOSE:

We are excited to expand our Medical Writing FSP Team in EMEA! This would be a remote role working from any location in EMEA. We are looking for a Principal Medical Writer to be dedicated to a client in the FSP space; experience in Immunology, Oncology or Vaccines would be valuable but not essential. As a Principal Medical Writer you will provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. As the lead writer, you will review documents for the team and provide training and guidance to junior team members. As a subject matter expert you will provide advice on document development strategy, regulations, and industry best practices. You will collaborate with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

ESSENTIAL FUNCTIONS:

• 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 also develop, review, and manage performance metrics for assigned projects.
• Represents the department at project launch meetings, review meetings, and project team meetings.