Associate Director, Medical Writing in Basking Ridge, New Jersey at DSI

Date Posted: 11/25/2019

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

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:
  • 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
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/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
Ability to travel up to 10%.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. 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.