- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- … issues related to development compounds or marketed products including labeling discussions/updates, interactions with Regulatory Agencies, and Annual NDA ... guidelines. Organizational Relationship/Scope: + This position reports to the Head of Global Medical Affairs. The Senior Medical Director will interact with… more
- BeOne Medicines (Emeryville, CA)
- …+ Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update ... including individual study design and filing plans. + Experienced in global regulatory requirements for pharmacovigilance. **Education Required:** + PharmD,… more
- Organon & Co. (Plymouth Meeting, PA)
- …2.7.2 and contribute to the authoring of modules 2.7.3, 2.7.4, 2.5 and labeling for regulatory submissions, contribute the authoring of Investigator Brochures, ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for...are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans.… more
- 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
- J&J Family of Companies (Titusville, NJ)
- …clinical study reports and for the preparation and approval of essential documents for global regulatory filings. The CL will manage direct reports who are ... matrix interactions also includes individuals from project management, TA strategy, global regulatory affairs, finance, legal, quality assurance, quality… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …Authority** + Approves quality decisions affecting donor safety, product quality, and regulatory compliance. + Together with Quality Assurance Director , makes ... the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working...more than 110 countries and regions. **Summary** : The Director of Quality Operations ensures that all plasma donor… more
- ThermoFisher Scientific (Fremont, CA)
- …Exposure to global operations including but not limited to packaging labeling , export documentation, duties, and regulatory approvals . Experience in ... food is safe or helping find cures for cancer. GROUP/DIVISION SUMMARY The Senior Director Operations is part of the division global operations leadership team… more
- ThermoFisher Scientific (Greenville, NC)
- …Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day ... our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping… more