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Associate Director, R&D Development IT, Regulatory - United States  

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Posted on : 02 June 2017

Project Description

Job Description
  • Our has one of the most exciting pipelines in the Biotech / Pharmaceutical industry. 
  • The company has been growing rapidly and with this growth comes a number of exciting opportunities to work with our expanding business areas. 
  • One of these opportunities is to work in R&D IT to support the growing needs of the Global Development (GDO) organization. 
  • The organization is proud of minimum bureaucracy, a nimble work environment where people work hard supported by an entrepreneurial spirit, coupled with a highly collaborative focus and significant opportunities for career advancement. 
  • Consistent with overall company dynamics, this is an exciting time for Global Development. GDO is now focused on revolutionizing all processes through a multi-year initiative to transform the fundamental business approaches and outcomes. 
  • The new Associate Director of R&D Development IT will be instrumental to bringing new and innovative technology capabilities to the GDO transformation.
  •  The Associate Director will serve as a strategic IT liaison to the GDO organization and will translate. S/he will focus on building strong partnerships and delivering operational, strategic and meaningful IT solutions. 
  • The successful candidate will ensure that IT has a role within all major strategic change initiatives and that the value of IT consultancy is recognized by the leaders.
  • S/he will act as a change agent to align the GDO IT portfolio with business strategy, the IT strategic plan and corporate IT architecture, and is responsible for communications between the Development business areas and other IT. 

The key activities for this position include:
  •  Understand the processes, plans, objectives, drivers, and issues related to Global Development Operations with emphasis on Regulatory Operations, Regulatory Affairs. 
  • Develop, communicate, and execute on a business-aligned IT strategy that will contribute to the success of our company's Global Development efforts.
  • Develop business cases, secure approval & resources required to pursue the development of new capabilities & investments, manage the development of requirement specifications related to these, and charter & guide the efforts of matrixed project teams in their implementation
  • Direct the proper execution of IT projects and services; ensure that the appropriate delivery-side & architecture resources are available to support & sustain projects; negotiate priorities and support requirements with shared services & infrastructure IT
  • Facilitate change via technology. Promote opportunities for applying technology to business problems; champion introduction of new or improvement of existing tools and solutions to improve efficiency and productivity of Global Development Operations. 
  •  Bring awareness of new technology and products to the business, support business re engineering as needed. 
  • Focus on solutions and services to provide seamless user experience.
  • The position reports to the Senior Director, Development IT, R&D IT.

  • 10+ years' experience working as an IT professional, with at least 5 years' experience in an IT leadership role
  •  5+ years' experience in IT program management and/or business analysis
  •  Candidates must be “current” on emerging technologies used to streamline and run “flawlessly” Global Development Operations processes, especially focused on leveraging technology to Regulatory Affairs and Pharmacovigilance. 
  •  Keenly developed business partnering & collaboration skills, adept at establishing & sustaining effective working relationships, both within & between departments
  • Promote opportunities for applying technology to business problems; champion introduction of new or improvement of existing tools and solutions. Bring awareness of new technology and products to the business, support business reengineering as needed.
  •  Demonstrated successful management of IT projects, including scope, financial, and schedule goals
  • Experience working with solutions delivery teams such as corporate IT infrastructure/architecture, applications development & integration, and support in the implementation and maintenance of scientific computing platforms & applications
  •  Ability to operate effectively in a matrix environment; team player

  • Experience selecting and implementing Regulatory Information Management, Submissions Planning, eTMF solutions
  • Familiarity with GxP and systems validation
  • Have an interesting personality that wants to do cool stuff and have some fun 

  • Ideal candidate should have at least a BA or BS in a relevant life science. 
  • Advanced degree strongly preferred, and/or a BS in computer science. 

About Us 
  •  Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. 
  • Our company  is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS).  
  • Our company  also manufactures and commercializes biosimilars of advanced biologics.   
  • Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.  
  • Our company  was founded in 1978 and today serves patients in nearly 70 countries.  

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