Senior/Principal Medical Writer (Remote)
Description:
Independently researches, writes, and edits clinical study reports, study
Protocols and standard response documents. Produces complex clinical or
Scientific documents, such as, IBs, and sections of INDs, NDAs, CTDs, and
Dossiers. Provides senior review of documents and training/mentoring for other
Writers.
-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). Identifies and escalates out-of-scope project activities
in a timely manner and proposes solutions
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
5+ years’) or equivalent combination of education, training, & experience.
Experience working in the pharmaceutical/CRO industry preferred
Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous