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Assoc dir medical writing

Daiichi Sankyo

This is a Full-time position in Basking Ridge, AZ posted May 21, 2019.

The primary responsibilities of this position are to establish strategies for document authoring, contribute strategically and scientifically at the project and/or study team level, manage CROs and external writers with regard to document quality, and develop medical writing timelines, processes, and working standards.

The position can independently serve as primary author of complex clinical documents (e.g., pivotal Phase 3 protocols and reports) and be a lead writer for NDA/MAA submission documents.

This position has advanced knowledge of NDA/MAA submissions, knowledge of document management systems, knowledge relevant therapeutic areas, and knowledge of other aspects of drug development (e.g., nonclinical, pharmacokinetics, biostatistics).

Responsibilities: Establishes strategy for document authoring; Determines resource needs, proactively identifies issues and solutions, and sets timelines and processes Writes critical, complex clinical documents (e.g., pivotal Phase 3 protocols and reports, NDA/MAA submission documents) with minimal input from functional area experts; Ensures key messages are clear and consistent within and across documents; Able to independently search scientific literature to place study results in context with other relevant data Contributes strategically and scientifically at the project and/or study team level; Contributes to formation of key messages in consultation with functional area experts (e.g.

Recommending data outputs for collection of specific data, proposing document strategy for filings or responding to health authority requests); Advises project and study teams regarding regulatory requirements and ICH guidance for clinical documents Manages CROs and external writers with regard to document quality; Provides guidance to CROs and external writers on company standards and style and industry best practices for medical writing Develops medical writing timelines, processes, and working standards; Ensures company SOPs, templates, style guides, etc, are aligned with industry best practices Manages other MWs, assess performance and perform mid and end of year appraisals Qualifications: Minimum 5-7 years of experience with a Master’s of Science degree or PhD or Minimum 7+ years of experience with a Bachelor’s degree Regulatory Medical writing experience required Submission document experience required Job Title Assoc Dir Medical Writing City Basking Ridge Functional Area Clinical Development Operations State New Jersey