Medical Writer

US-NJ-Princeton
Requisition ID
2017-9806

Responsibilities

The Medical Writing is a writing-based position within our Global Regulatory Affairs department. He/she will ensure communications are complete, well organized and scientifically accurate, and that messaging is consistent throughout all technical documentation. He/she will manage processes intended to increase project efficiency, quality and the timely achievement of deliverables and ensure the needs of business are met, particularly in the preparation of accurate, timely, and multidisciplinary documents submitted to regulatory agencies worldwide.

 

  • Proactively manages writing activities across assigned projects as appropriate, ensuring adherence to the medical writing strategy and alignment with business needs.
  • Contributes to therapeutic project teams as the medical writing expert for regulatory submission documents. Authors deliverables with consideration for regulatory, corporate, departmental, and quality standards (documents include but are not limited to protocols, clinical study reports, Investigator’s Brochures [IBs], annual reports, HA briefing packages and response documents, and integrated data summary reports).
  •  Adheres to Medical Writing practices/systems/tools to support clinical studies in order to meet company goals and objectives. Assures that standardized practices are implemented and maintained across all therapeutic areas.
  • Engages with team members to ensure medical writing continues to deliver value to the business.
  • Ensures medical writing activities meet quality standards and expectations and adhere to applicable Corporate SOPs, WPs, policies, guidelines and regulations.

Qualifications

Required:

  • Minimum of a BA/BS in Life Science.
  • 3-5 years pharmaceutical/biotechnology experience related to clinical research
  • Demonstrated expertise in writing/developing clinical documents in support of regulatory submissions globally Ability to interpret and organize scientific and clinical data
  • 3+ years medical writing experience in Pharma, Biotech and/or CRO, necessary
  • Experience with ICH and electronic submission guidelines for regulatory reports.
  • Good leadership, communication, and influencing skills
  • Ability to collaborate with a wide variety of internal customers and relate effectively to people at all levels of the organization.
  • Ability to manage change successfully and identify process improvements   
  • Applies good judgment and demonstrates initiative to resolve issues
  • Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook)
  • Excellent written and verbal skills
  • Ability to enact change and foster an innovative atmosphere

Overview

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016. 


All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

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