5 August, 2022
Thermo Fisher Scientific Hiring Senior Medical Writer
Serves as primary author who writes and provides input on routine documents such as clinical study reportsand study protocols, and summarizes data from clinical studies.
- May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
- Reviews routine documents prepared by junior team members. May provide training and mentorship for junior 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. Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client-specific processes.
- May assist in program management activities. Identifies andresolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications.
- Represents the department at project launch meetings, review meetings, and project team meetings.
Bachelor’s degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferredPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).Experience working in the pharmaceutical/CRO industry preferredAdditional qualifications in medical writing (AMWA; EMWA; RAC) advantageous.
Knowledge, Skills and Abilities:
- Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
- Strong project management skills
- Excellent interpersonal skills including problem solving
- Strong negotiation skills
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of global, regional, national and other document development guidelines
- In-depth knowledge ina specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc
- Great judgment and decision-making skills
- Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)