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Career Openings


Sr Specialist, Analytical Data Management

ID: 1589
Department: Analytical Development
Location: Cambridge Headquarters
# of Openings: 1

Description

Senior Specialist, Analytical Data Management sought by Ironwood Pharmaceuticals, Inc., a commercial biotechnology company, to maintain stability schedules for internal and external studies, track receipt of summary reports, and compile stability data into cohesive repository for trending and analysis. Manage archiving of Pharmaceutical Development reports and other regulatory content into regulated document repository. Perform QC review of regulatory documents versus data sources prior to submission. Work cross-functionally with colleagues from IT and Quality to adapt data and document management systems as required. Act as an engaged group member supporting CMC project teams in fast-paced and dynamic environment.
 
Position located in Cambridge, MA.  
 
Requirements include a Bachelor’s degree or equivalent in Chemistry, Pharmaceutical Sciences, Pharmacy, or related physical science field and four years of work experience in the job offered or related field of analytical testing experience in the pharmaceutical industry; or in the alternative, a Master’s degree or equivalent in Chemistry, Pharmaceutical Sciences, Pharmacy or related physical science field and two years of work experience. 
 
If qualifying with a Bachelor’s degree or equivalent, must have at least four years with stability study setup and execution. Must have at least four years experience with checking calculations used in validating and applying various test methods. Must have at least four years experience reviewing analytical data, study documents, and reports, including verification of data from source documents. Must have at least four years experience with document management processes and applications software, such as enterprise quality management software (EQMS) and Sharepoint.
 
If qualifying with a Master’s degree or equivalent, must have at least two years with stability study setup and execution. Must have at least two years experience with checking calculations used in validating and applying various test methods. Must have at least two years experience reviewing analytical data, study documents, and reports, including verification of data from source documents. Must have at least two years experience with document management processes and applications software, such as enterprise quality management software (EQMS) and Sharepoint.
 
If qualified, apply below. 
 
Ironwood Pharmaceuticals is an equal opportunity employer welcoming diversity in our workforce


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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