Postdoctoral Research Fellow, Ironwood Pharmaceuticals--Global Patient Safety & Regulatory Affairs

About the Opportunity

About the Opportunity: 

Northeastern University Pharmaceutical Industry Fellowships Program is a two-year experiential program designed to advance lifelong learning and the education and training of Pharm.D. graduates. Critical to the success of the program is our ability to prepare Fellows to meet the ongoing workforce needs in various areas of industry.  

Our program gives fellows an opportunity to work with our innovative biopharmaceutical industry partners while collaborating with Northeastern University faculty in professional and career development, service, scholarship, and teaching. 

In partnership with Northeastern University, Ironwood Pharmaceuticals is offering a two-year Global Patient Safety and Regulatory Affairs PharmD fellowship based in Boston. 

Company Summary: 

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), which is the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) and is also indicated for the treatment of functional constipation in pediatric patients ages 6-17 years old. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure (SBS-IF), as well as several earlier stage assets.  

Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs. With a seasoned GI leadership team at the helm, deep relationships within the GI community, and a proven track record of success, we are poised to unearth new opportunities to create next-generation GI advancements.  

Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, with a site in Basel, Switzerland. 

Responsibilities: 

The purpose of the Global Patient Safety and Regulatory Affairs (GPS/RA) Fellowship is to provide the fellow with training in both functional areas to prepare them to enter an industry role as an individual contributor in safety or regulatory after the end of their 2-year fellowship. The cross-functional collaboration between these two groups is essential to both the development of a therapeutic product and management of that product throughout its life cycle.  By gaining experience in both functional areas, the fellow will be able to pursue a career in either function and allow them to have a practical understanding of the other function’s responsibilities to enable them to be an optimal collaborator and colleague.   

During the first year of the fellowship, the fellow will work within GPS to gain experience in case processing operations, safety database management, signal detection, signal management, aggregate reports, safety governance, and advanced pharmacovigilance analytics.   

 During the second year of the fellowship, the fellow will work within regulatory affairs to gain experience in global/regional labeling, maintenance of IND and/or NDA applications, regulatory strategy, regulatory intelligence, Agency meeting management and correspondence, and regulatory operations.  

In both functions, the fellow will have the opportunity to work collaboratively with other functional areas within Ironwood including clinical development, medical scientific affairs, program management, data sciences, quality and compliance, nonclinical, medical writing and publications, and chemistry, manufacturing, and controls as well as experience partner interactions and engage in vendor oversight. Additionally, the fellow will have the opportunity to precept students, present guidance reviews, and other opportunities as they arise.