- Takeda Pharmaceuticals (Boston, MA)
- …area knowledge relevant to mechanisms of action of compounds in remit + Regional/ global Regulatory requirements + GCP/ICH + Emerging research in designated ... Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, … more
- Amgen (Cambridge, MA)
- …and implement strategy for commercial drug product programs, life-cycle management, global regulatory submissions, and variation management for biologics, ... key messages relative to diverse audience requirements + Knowledge of applicable global regulatory requirements. Experience preparing technical sections of … more
- Candela Corporation (Marlborough, MA)
- …personal relationships even in heated or difficult/dynamic circumstances. . Global accountability for Design/Supplier Quality performance, Sterilization/ Labeling ... **Sr. Director , Design and Supplier Quality** Requisition Number **2882**...regulatory / compliance. . Working understanding of relevant global /regional medical device regulations and standards with particular emphasis… more
- Evident Scientific (Needham, MA)
- …operations, supporting submissions, inspections, and QMS compliance activities. Reporting to the Global Director of Regulatory Affairs - Clinical Business, ... documentation, labeling , and registration activities. + Contribute to global regulatory strategy discussions, providing US compliance insights. **Leadership… more
- Takeda Pharmaceuticals (Boston, MA)
- …regulatory submissions, investigational and new drug applications and interactions with regulatory authorities worldwide. + Assists the Global Medical Safety ... Description** **About the role:** Join Takeda as a Senior Medical Director , Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You will oversee medical… more
- Takeda Pharmaceuticals (Boston, MA)
- …inspire you and empower you to shine? Join us as a Executive Medical Director , Oncology Clinical Sciences in our Cambridge office. At Takeda, we are transforming the ... people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for… more
- Takeda Pharmaceuticals (Boston, MA)
- …well as other labeling documents. + Demonstrate knowledge of local and global health authority requirements. + Support GPSE in the maintenance of a highly ... knowledge. **Job Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert… more
- Bristol Myers Squibb (Devens, MA)
- …Provide Subject Matter technical expertise for equipment ensuring continued compliance to regulatory , company and site policy and procedure. + Provide Subject Matter ... selection, and Arc Flash Analysis and maintenance of Incident Energy equipment labeling . + Perform review of electric rooms and maintain cleanliness, organization,… more