Associate Director Medical Writing at Otsuka Pharmaceutical Company in Princeton, NJ

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Description

Responsibilities

The Associate Director of Medical Writing combines elements of both leadership and document
authoring contributorship to further medical writing activities across OPDC. He/She will
participate in the implementation of medical writing operational plans and development of
innovative solutions for medical writing activities across OPDC. He/she will work with
outsourced medical writing teams to ensure delivery of high-quality regulatory writing services in
accordance with applicable regulatory regulations. He/she will ensure communications are
complete, well organized and scientifically accurate, and that messaging is consistent
throughout all technical documentation. He/she will apply knowledge and make
recommendations of best practices to maximize the value of medical writing services.
Additional responsibilities include developing and managing interpersonal relationships both
within and outside of OPDC. The Associate Director, Medical Writing 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.

Key Job Responsibilities
- Authors and/or reviews clinical documents 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).
- Contributes to process development/improvement with the OPDC MW management team
(including SOPs, WIs and document working groups).
- May manage and oversee medical writing activities, ensuring adherence to the medical
writing strategy and alignment with business needs.
- Contributes to therapeutic project teams as a medical writing expert for regulatory submission
documents. Acts as a cross-functional liaison both internally and externally to manage
document preparation processes.
- Adheres to Medical Writing practices/systems/tools to support OPDC clinical studies in order
to meet company goals and objectives. Assures that standardized practices are implemented
and maintained across all therapeutic areas.
- Creates and implements project writing plans.
- Supervises contract managers and writers, as needed.
- Participates in creation and maintenance of model documents (templates) and the Otsuka
style guide.
- Focuses on recognizing efficiencies and innovative new solutions identified through process
Improvements.
- Ensures medical writing activities meet OPDC quality standards and expectations and adhere
to applicable Corporate SOPs, WPs, policies, guidelines and regulations.
Assesses Industry regulations, guidance’s, and best practices and prepares recommendations
for adoption by MW staff.

Qualifications

Required:


- Minimum of a BA/BS in Life Science with a Master’s degree strongly preferred
- At least 7 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
- Supervisory experience preferred
- Experience with ICH and electronic submission guidelines for regulatory reports.
- Excellent leadership, communication, and influencing skills
- Ability to provide direction with cross-functional teams in highly matrixed team environment,
collaborate with a wide variety of internal customers and relate effectively to people at all
levels of the organization
- Ability to manage and enact change, identify process improvements, and foster innovation
- 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

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 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 50,000 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.

 

 

Disclaimer: 

 

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

 

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

 

 

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