Associate Director Medical Writing in Bernards, NJ at DSI

Date Posted: 2/20/2018

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo, Inc. is the U.S. subsidiary of Daiichi Sankyo, Co., Ltd. The Company currently markets therapies in hypertension, dyslipidemia, diabetes, acute coronary syndrome, thrombotic disorders, stroke risk reduction, opioid-induced constipation, IV iron therapy and metastatic melanoma.

Job Summary

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

1. Establishes strategy for document authoring; Determines resource needs, proactively identifies issues and solutions, and sets timelines and processes
2. 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
3. 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
4. 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
5. Develops medical writing timelines, processes, and working standards; Ensures company SOPs, templates, style guides, etc, are aligned with industry best practices
6. Manages other MWs, assess performance and perform mid and end of year appraisals

Qualifications

Education and Experience
  • 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
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.