Medical Writer

October 8

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• Provides high-quality regulatory medical writing for internal and external clients. • Provides technical consultation and substantive advice on strategy, regulations, and industry best practices. • Effectively manages medical writing projects to deliver quality products in agreed timelines. • Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence. • Independently researches, writes, and edits peri-/post-approval clinical study reports, study protocols, informed consent forms, and other peri-/post-approval regulatory documents. • May support complex clinical or scientific documents, such as, IBs, and sections of INDs, NDAs, and CTDs. • Manages all aspects of planning, organizing, and executing projects without supervision including: developing project timelines, standards, budgets, forecasts, and contract modifications. • Liaises with other functional units as necessary (i.e., project management, clinical, QA, data management, biostatistics, regulatory, and other Evidera practice areas). • Identifies and escalates out-of-scope project activities in a timely manner and proposes solutions. • Represents the department as a primary contact on projects including project launch meetings, review meetings, client audits, bid defenses, and capabilities presentations.

Requirements

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic/vocational qualification; Advanced degree preferred. • Previous experience as a writer that provides the knowledge, skills, and abilities to perform the job (comparable to 2-5 years’ ) or equivalent combination of education, training, & experience. • Experience working in the pharmaceutical/CRO industry is preferred. • Additional qualifications in medical writing (AMWA; EMWA; BELS; RAC) are advantageous. • Significant knowledge of global, regional, national, and other document development guidelines. • In-depth knowledge in a specialty area such as therapeutic, regulatory submissions, healthcare communications, etc. • Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).