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Career Openings


Regulatory Support Associate/ Coordinator

ID: 1595
Department: Regulatory Affairs
Location: Cambridge Headquarters
# of Openings: 1

Description

It’s an exciting time for Ironwood. After two decades of growth and innovation, in 2018 we announced our intent to create two focused, independent companies: Ironwood and “R&D Co.” This new way of doing business will enhance our agility and innovation, and empower our teams to make a bigger impact on our patients and on our industry.

The new Ironwood will focus on accelerating the growth of our marketed product Linzess® (linaclotide) and advancing the development of our innovative pipeline of treatments for GI diseases and abdominal pain. Following completion of the separation, the Regulatory Support Associate position will be part of the new Ironwood. The role will remain as described here.

The position provides regulatory affairs support for the Global Regulatory Affairs organization, including preparation and management for routine regulatory submissions in the Regulatory Strategy group and support and coordination for multiple assigned initiatives, projects and activities such as contract management, budget preparation and tracking, and SharePoint management. This role will also provide focused for tactical support of Head of Regulatory, including coordination of strategic regulatory meetings, licensing, contractor management and travel support, as needed.

 

Responsibilities

 

Regulatory Coordinator:

  • Prepare regulatory documents for routine submission
  • Draft Agency submission cover letters, as requested

  • Organize and manage investigator submissions, as requested

  • Health Authority Communication Management - Upload, track, and provide reports for communications and commitments from Health Authorities as requested; Train new employees as needed

 

Regulatory administrative support for Regulatory department:

  • Contract Management, Consultant Management and Financial Support (T&E prep, Dept invoicing)   

  • Budget preparation and management

  • Licensing - Manage department subscriptions

  • General Meeting Support, Department Meetings, Travel support

  • Update and maintain department internal website (SharePoint)

  • Provide focused administrative support to the Regulatory Affairs department

 

Requirements

  • Bachelor’s degree with 2 years of relevant experience in a regulated environment or Associate’s degree and 5 years of coordinator/ administrative experience, in a similar, fast paced environment

  • Experience in the Pharmaceutical industry a plus

  • Excellent written, verbal, and interpersonal communication skills

  • Strong computer skills in Word, Excel, PowerPoint, Outlook. 

  • Familiarity with SharePoint (Office 365), SAP, Concur, Veeva, ARIM a plus

  • Proactive, detail oriented, able to multi-task

  • Excellent time management and ability to prioritize work and meet deadlines

  • Experience working in a cross-functional environment


Ironwood is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.





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