Job Category: Clinical & Statistics

TA Lead, Medical Writing (BME)

Job Location: NJ/PA/MA

TA Lead, Medical Writing (Director Level) (BME)
NJ/PA/MA

Lead and manage a team of professional Medical Writers engaged in the planning, authoring, compilation, review, and approval of medical, scientific, regulatory documents. Works in collaboration with the other managers in Clinical Development and Operations. Define platform strategy and provides guidance and leadership in development medical writing related processes.

RESPONSIBILITIES:
Manage a global team of medical writers. Leads and manages the Medical Writing team; responsible for recruitment, management and development of medical writers globally. Plans and manages the day-to-day assignment of work to individual medical writing team members. This includes writing of clinical study protocols, study reports, Phases I-IV, informed consent documents, investigator’s brochures, briefing packages and clinical CTD summary documents. Ensures that MW complete all required documentation related to their work on clinical documents including filing required documents to the TMF.

EDUCATION/EXPERIENCE:
An advanced degree in Science with expertise in the writing of clinical regulatory documents used to support clinical development and licensure. Two to three years’ experience directly managing medical writers engaged in the preparation of CTD submissions and other regulatory documents. Mandatory; Management Experience; Medical Writing Expertise.

Please contact Bill Emker at bemker@clarkdavis.com

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