- Bristol Myers Squibb (Madison, NJ)
- …and company objectives. + Develop strategic direction and provide leadership for all regulatory interactions with FDA/ global regulatory authorities + Lead ... personal lives. Read more: careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of Global Project Team (GPT)… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …to build/maintain database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for content ... Global Regulatory Sciences (GRS) and Global Product and Supply (GPS). The GRS-CMC Associate... Global Product and Supply (GPS). The GRS-CMC Associate Director , Biologics will assess Manufacturing Change… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director of Regulatory Writing is a key role ... and strategic insights at the study team level. The Associate Director of Regulatory Writing...for clinical documents + Participate in initiatives within the Global Regulatory Writing Group to identify process… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Job Summary:** The Associate Director of Regulatory Writing is a key role ... and strategic insights at the study team level. The Associate Director of Regulatory Writing...for clinical documents. + Participate in initiatives within the Global Regulatory Writing Group to identify process… more
- Bristol Myers Squibb (Madison, NJ)
- …more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... (HA) queries. + Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy… more
- Bausch Health (Bridgewater, NJ)
- …your skills and values drive our collective progress and impact. The Associate Director , Advertising and Promotion, Prescription Drug Products, reviews, approves ... Join a team! We are a global diversified pharmaceutical company enriching lives through our...product advertising and promotional labeling pieces for compliance with regulatory agency requirements. Responsibilities **:** + Provides regulatory… more
- Bristol Myers Squibb (Summit, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Title: Sr. Manager / Associate Director , Global Sterility Assurance CTTO** **Location: ... BMS with our Cell Therapy team. T he **Sr Manager/ Associate Director - Sterility Assurance, Cell therapy... regulatory requirements. + Extensive knowledge of applicable global regulatory standards which apply to both… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …The candidate will be responsible for leading the development and execution of global regulatory strategies for biologic products and combination products for ... marketing of drugs and/or biologics. + Lead and facilitate interactions with global regulatory authorities (eg, meetings, IR responses, inspections). + Perform… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner ... process improvements or other special projects. May initiate and/or contribute to global process improvements. + Provides regulatory guidance on new marketing… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Global Real World Evidence (RWE) Oncology (Solid Tumor) - 2406216357W **Description** Johnson & Johnson Innovative Medicine is recruiting ... an Associate Director , Global Real World...evidence generation functions, and others. + Ensure compliance with regulatory , legal and commercial regulations in conducting research and… more
- Scotiabank (New York, NY)
- Associate Director , US Global Capital Markets, COO **Requisition ID:** 206211 **Salary Range:** 225,000.00 - 225,000.00 _Please note that the Salary Range ... winning team, committed to results, in an inclusive and high-performing culture. **Title: Associate Director , US Global Capital Markets COO** ** Global… more
- Scotiabank (New York, NY)
- Associate Director , Multinational Corporate Sales, Global Transaction Banking **Requisition ID:** 201003 **Salary Range:** 110,700.00 - 211,800.00 _Please ... committed to results, in an inclusive and high-performing culture. ** Associate Director , Multinational (MNC) Sales, Global...Stay keenly aware of the changing macro environment and regulatory landscape, and their impact on the industry and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... responsibility to collaborate with, and support the head of Global QA strategy and operations. In this position, the...individuals are current and up to date - Support regulatory inspection related activities as required - Support Head,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... value from inception through to implementation. Demonstrates ability to handle global projects through established interactions with Japan and Europe as required.… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- We are seeking an Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the ... of study data of a clinical development program. The Associate Director leads in a matrix environment...other departments; Member of the Clinical Study Team and Global Clinical SubTeam + Maintains proficient understanding of therapeutic… more
- Merck (Rahway, NJ)
- …Operations. We are seeking a highly motivated individual for the role of Associate Director , Tech Transfer Leader in Large Molecule Technology Transfer within ... Drug Substance and Drug Product for all large molecules. Associate Director is expected to contribute to...conflict resolution and problem-solving skill. + Strong knowledge of global regulatory guidelines and cGMP principles. +… more
- Pfizer (New York, NY)
- **ROLE SUMMARY** + The Medical Writer (Senior Manager/ Associate Director ) creates documents pertaining to clinical studies and regulatory interactions, ... technology, and new processes that impact Medical Writing. + Proficiency with global regulatory guidance (especially ICH, FDA, and EMA) relevant to clinical and… more
- AbbVie (Branchburg, NJ)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Clinical Development will have global or regional responsibilities and ... Lead and Clinical Science Lead and Clinical Scientist. The Associate Director , Clinical Development should expect to...and timely solutions. He/she leads the development of the Global Development Strategy, in collaboration with the IEST and… more