Manager of Medical Writing

This position will be located in Southern California (Relocation will be offered)

 

Responsibilities:  Oversee the medical writing function for clinical development programs. Oversee the work of in‑house and contract writers assigned to the development program. Hire, train and mentor new medical writing staff to support the clinical development program. Allocate resources to ensure that that writing assignments are completed according to company guidelines.  Function as a key member of clinical development teams during all phases of development and work with clinical scientists, statisticians, programmers, project managers and other writers. Author and/or review regulatory submission documents such as protocols, clinical study reports, investigator?s brochures, clinical summary documents, case report forms and statistical analysis plans.  Facilitate internal review of materials or documents and consolidate comments from internal and external reviewers.  Act as liaison between cross-functional department personnel, managing selected projects to ensure background materials are provided, timelines are communicated, questions are answered, and drafts and comments are exchanged.  Author or update SOPs and guidelines as appropriate for department. 

 

Requirements: 

? Master?s degree in a scientific or medical discipline with 5-8 years of medical writing experience in the pharmaceutical industry or a research organization that conducts clinical trials, or a PhD in a scientific or medical discipline with 3-5 years experience in the pharmaceutical industry or a research organization that conducts trials. 

? Supervisory experience.Demonstrated leadership skills. Strong written communication skills. Familiarity with clinical research, biostatistics and regulatory affairs is highly desirable.  Familiarity with GCPs, eCTDs and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines is preferred. Ability to understand and interpret data analyses.