Posted to MedZilla on 3/24/2017


Takeda Pharmaceuticals

US-MA, Director, Non-Clinical Writing 1601968-MZ


 
 

Please note that the requirements specified in this posting are the basic qualifications required for the Director, Non Clinical Writing position; however, job title will be dependent on the candidate's level of experience in those requirements.

OBJECTIVES:

We have a challenging opportunity for a Director, Non Clinical writing group based in Cambridge, MA, reporting to the Senior Director, Global DMPK head of Strategy and Operations.

The candidate will provide global nonclinical strategic direction and leadership to a group of writing and documentation staff. Candidate will possess strong knowledge of GxP and experience in regulatory submission processes, writing, and nonclinical content. In this leadership role, the candidate will be responsible for working cross-functionally to develop and implement global strategies, operational plans, and innovative solutions for nonclinical writing activities. The candidate will interface with external groups including global DMPK, Toxicology, Pharmacology, Regulatory, Clinical, Quality, and Publishing to implement strategies and initiatives. The candidate will have a strong understanding of the day-to-day responsibilities of the group and the various functional interdependencies related to submission management.


ACCOUNTABILITIES:

Major Responsibilities:

  • Provides leadership and guidance for development of the Nonclinical Writing and Documentation Group.
  • Develops, implements, and executes strategic global nonclinical writing initiatives.
  • Oversees compliance with relevant internal and external standards, and maintains a functional group that meets or exceeds industry standards.
  • Assesses resource and budget needs and communicates those needs to senior management.
  • Provides expert knowledge of US and international regulations, requirements, and guidances associated with regulatory submissions.
  • Resolves nonclinical issues and questions arising during the regulatory process.
  • Possesses strong writing and editing skills that can be used to further develop the group s capabilities.
  • Provides guidance and expertise with both nonclinical content and regulatory writing.
  • Provides support for both regulatory and non-regulatory EDMS systems.
  • Oversees management of nonclinical GLP archiving room.
Qualifications
EDUCATION/QUALIFICATIONS/REQUIREMENTS
  • Masters or PhD in science discipline preferred.
  • American Medical Writing Association (AMWA) or Board of Editors in the Life Sciences (BELS) certification is preferred.
  • 8-10 years relevant industry experience preferred.
  • Expertise in International Conference on Harmonisation (ICH) guidelines (ie, Common Technical Document [CTD]).
  • Strong knowledge of document management systems (ie, Documentum, SharePoint, Qumas)
  • Excellent written and oral communication skills. Expert in interpretation of scientific content with ability to translate for the appropriate audience.
  • Excellent working knowledge of the Microsoft Windows software suite (Word, Excel, PowerPoint, Project) environment.
  • Extensive experience working with collaborative, cross-functional teams.
  • Creates a learning environment, embraces the ideas of others, and nurtures innovation.
  • Has the ability to transform innovative ideas into solutions

we are driven to improve people's lives


www.takedajobs.com

Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx

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*LI-MB2-USA


Schedule
Full-time

Please visit our website at takedajobs.com

 
 


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