Description
We are looking for qualified Clinical Medical/Technical Writer to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.
Skills:
- Bachelor's or higher degree preferred; scientific focus desirable.
- Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing.
- Evidence of medical writing career development, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.
EXPERIENCE
Fulfills one of the following:
Up to 2 years of as a medical writer in the medical device industry
At least 5 years of medical or scientific writing experience as a primary job responsibility
Medical Writing
Experience writing, reviewing, or editing protocols and clinical study reports and literature based clinical evaluations highly preferred.
Intermediate to advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content.
Intermediate to advanced applied knowledge of AMA, CBE, and Chicago Style Manuals.
Ability to interpret basic tabular and graphical clinical data presentations.
Ability to create basic tables using AMA style (eg, Schedule of Events).
Intermediate applied knowledge of basic clinical laboratory tests.
Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
Basic understanding of biostatistical and clinical research concepts.
Regulatory
Basic knowledge of regulatory requirements and guidance associated with standalone' regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
Responsibilities:
Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, clinical study reports; and technical dossiers
Conducts comprehensive literature evaluations, product complaint reviews, and other product specific information to compile literature based clinical evaluation reports.
Manages study team participation in the preparation of such documents, including calling/running meetings, developing timelines, and managing the document review and comment adjudication processes
Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
Company Profile:
Synergy America, Inc is a 16-year-old Professional Services staffing firm providing contract, contract-to-hire and direct-hire resources to companies looking for key individuals. We specialize in providing top-notch talent for our clients, and help candidates in finding the right position.
We rely on our knowledge of search and hiring procedures. We consider both the companies and the candidates to be our clients. We believe in providing the highest level of service to our clients at all times.