- Takeda Pharmaceuticals (Trenton, NJ)
- …company that will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning ... - Neuroscience TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global … 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
- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Strategy Princeton, NJ, USA Req #415 Wednesday, November 27, 2024 Looking for a chance to make a meaningful difference ... of regulatory affairs management, the incumbent independently prepares and directs global regulatory affairs activities and provides regulatory guidance… 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
- Bristol Myers Squibb (Princeton, 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
- Takeda Pharmaceuticals (Trenton, NJ)
- …identifying innovative opportunities to improve processes and infrastructure in line with global regulatory expectations and Global Regulatory ... Regulatory components of PSMF reporting, adapting strategies based on evolving global regulatory landscape. + Acts as a primary source for business RIM system… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …to department and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and ... including preparing briefing books, planning rehearsals, and risk mitigation. Represent Global Regulatory on cross-functional teams to address regulatory… 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
- Takeda Pharmaceuticals (Trenton, NJ)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be ... escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products… more
- Bristol Myers Squibb (Princeton, NJ)
- …therapies enabling global regulatory approval and launches. The ** Associate Director , Program Management** plays an important role in organizing, ... work and in their personal lives. Read more: careers.bms.com/working-with-us . **Title:** Associate Director , Program Management, Global Operations (Inline… 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 ... feasibility and delivery. The role supports all phases of systems development for global informatics systems, ETL and integrations. The Tech Lead must develop and… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …to the best of my knowledge. **Job Description** **Objectives:** As part of the Global Evidence and Outcomes (GEO) team, this position is focused on documenting the ... decks, statistical analysis plans, briefing packages, clinical study reports, and regulatory labelling interactions. Ensure these reflect the COA needs from key… 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
- J&J Family of Companies (Raritan, NJ)
- Johnson & Johnson Innovative Medicine is recruiting for Associate Director , RA Submissions. The position can be located on-site/hybrid in the US (Titusville, NJ; ... execution of the global operational submission strategy in alignment with Global Regulatory Team (GRT) and Global Filing and Launch Strategy (GFLS) goals… more
- Bristol Myers Squibb (Princeton, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . Associate Director , Statistical Programming, provides functional expertise and ... of technical solutions for integrating, analyzing and reporting clinical data. Associate Director drives the development and implementation of innovative… more
- United Therapeutics (Trenton, NJ)
- …for cardiovascular and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Associate Global PV Case Management Director plays a key ... oversight of end-to-end case safety management activities spanning across our global commercial product portfolio. This position strategizes and implements plans to… more
- Merck (Rahway, NJ)
- …component of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. This ... Associate Director will work with scientists within...analyses + Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and… more
- Novo Nordisk (Plainsboro, NJ)
- …development. Are you ready to maximize your potential with us? The Position The Associate Director , Data & Analytics Governance is responsible for the governance ... the opportunity to build a life-changing career in a global business environment. We encourage our employees to make...vision is maintained across various NNI functions. Relationships The Associate Director , Data & Analytics Governance reports… more
- AbbVie (Florham Park, NJ)
- …standards, including regulatory guidelines to meet customer needs. Qualifications Associate Scientific Director Qualifications + Bachelor's Degree in the ... level will be determined by the qualifications listed below. Purpose The Associate Scientific Director provides medical and scientific strategic and operational… more
- Church & Dwight Co., Inc. (Princeton, NJ)
- …biggest impact because: Together We Have the Power to Win. Job Description The Associate Director of R&D Technology Development is responsible for guiding and ... advancing our global technology innovation initiatives for our Personal Care and...findings to various teams including technical, marketing, legal, and regulatory . + Act as the main liaison for external… more