- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs Team. **How you will contribute:** + As Associate Director , Global Regulatory Project Management and Strategic Planning, ... life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory...changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues… more
- Takeda Pharmaceuticals (Boston, MA)
- … requirements. You will serve as the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that regulatory labeling ... life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead...+ Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts… more
- Merck (Boston, MA)
- …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... world. **Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is... regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or… more
- AbbVie (Waltham, MA)
- …multiple driver indications within a Therapeutic Area and supports the Manager ( Global Regulatory Lead (GRL), Associate Director , or Director ), in ... Advise internal customers who may contribute to regulated communication on Regulatory /FDA issues including Public Affairs , Clinical Development, Legal, and… more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... regulatory filing, and publication. **Specifically, The Senior Clinical Director May Be Responsible For:** + Evaluating pre-clinical and translational work… more
- Fresenius Medical Center (Waltham, MA)
- …on projects with other FME departments including Compliance, Regulatory Affairs , Clinical Services, the Medical Office, Global IP, and others. ... manufacturers, and related entities. Under the general supervision of an Associate General Counsel or his/her designee, the Fellow undertakes projects supporting… more
- Novo Nordisk (Lexington, MA)
- …personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs , Global Safety, Data Management, and ... the written deliverables that support the clinical development and regulatory requirements of a clinical program. The Medical Writer...personnel. Relationships The Medical Writer (MW) reports to an Associate Director of Medical Writing. The MW… more