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The World Leader In Serving Science
Principal Medical Writer – Germany
Location
Germany
Posted
59 days ago
Salary
0
Seniority
Lead
Job Description
Principal Medical Writer – Germany
Thermo Fisher Scientific
• 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
Job Requirements
- 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
- Experience in Neurosciences advantageous
- Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
- 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
Benefits
- Competitive salary
- Flexible working culture
- Award-winning learning and development programme
- Extensive benefits package
- Health and well-being programs
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