-
correspondence Global/regional labeling Regulatory operations The fellow will have the opportunity to work collaboratively with other functional areas within Ironwood, including global patient safety, clinical
-
drug applications and international marketing authorization applications Collaborate with Clinical, Global Patient Safety and Risk Management, Biostatistics, and Medical teams in US and EU to achieve
-
to the therapeutic area to conduct clinical studies, including study start-up, safety and medical monitoring, and study close-out activities · Support Medical Lead with medical monitoring reports, safety reviews
-
), labeling, and health authorities' interactions, while collaborating with cross functional teams across Clinical, Safety and CMC. The program also includes a 6-month rotation in Commercial Regulatory Affairs
-
-functionally with other expertise areas such as Pharmacovigilance/Safety, Quality, Legal, Regulatory Affairs, Commercial, Clinical Operations, Clinical Development, and Information Technology, to ensure the safe
-
to the development of clinical sections of regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, and responses to Health Authorities questions
-
applications · Collaborate with Clinical, Global Patient Safety and Risk Management, Biostatistics, and Medical teams in US and EU to achieve regulatory milestones · Participate in cross-functional