- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …standards and timelines and that quality of data is suitable for regulatory submission . The Associate Director will have routine interaction with key internal ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier ... a seamless flow of documents in order to meet submission timelines. The Director will develop the... of Dossier Planning will report to Head of Global Regulatory Operations and be an active… 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 ... areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Director US Oncology Policy position is a high exposure and high impact commercial role accountable for executing key policy initiatives ... ensuring appropriate patient access to our Company's life-saving cancer treatments.The Associate Director , US Oncology Policy will report to the Director of… more
- Merck & Co. (Durham, NC)
- …the highest quality of raw materials, intermediates and finished products.GENERAL SUMMARY The Director of Operations (Integrated Process Team (IPT) Lead) is an ... Job DescriptionOur Manufacturing Operations teams are the people that make our...team to deliver the facility startup, process validation, regulatory submission , PAI, and ultimately the commercial manufacture of the… more
- Merck & Co. (Rahway, NJ)
- …to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their ... within the General Medicine Therapeutic Area, functioning as the single, accountable, global point of contact on those projects.Functions as first liaison assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …new medicines to help peopleUnder the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... quality compound and multi-compound level deliverablesLead the development of global harmonization of programming processes supporting global … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …but not limited to Group Heads in Clinical Development, Asset & Portfolio Management, Global Clinical Operations , BDM and DLT membersHe/she will also serve as ... be the Clinical Science Group Lead in late phase development in the Global Clinical Science functionHe/she will be responsible for managing the multiple Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of global harmonization of programming processes supporting global submission .Responsibilities- Statistical Programming Management: Coordinates outsourced ... 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
- Eisai, Inc (Nutley, NJ)
- …we want to hear from you.The incumbent will be an integral member of the Global Value & Access (GV&A) team and is responsible for the design and implementation of ... and need for project amendments.Mapping of payer/HTA engagement timelines for key global markets and coordinate stakeholders' engagement and responses to HTA 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 ... with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance of higher level. Reviews and oversee completion… more
- BeiGene (Emeryville, CA)
- …leadership to Regulatory Submissions Operations Management teams (eg Regional Submission Operations , Submission Dossier Management, Publishing, and ... & Responsibilities:** + Leadership role in the establishment and development of Submission Operations personnel (including Publishing team and Submission … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** The Director , Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier ... a seamless flow of documents in order to meet submission timelines. The Director will develop the... of Dossier Planning will report to Head of Global Regulatory Operations and be an active… more
- BeiGene (San Mateo, CA)
- …corporate vision, mission, and values. As the Head of Global Regulatory Operations , the SD will lead key functions ( Submission Operations Management ... Senior Director is responsible for setting the vision and mission for the Global Regulatory Operations &GRA Excellence function. The head of GRO and GRA… more
- American Express (New York, NY)
- …transformation with increased enterprise focus and momentum, fueling program growth. The Director of Amex Offers Operations will report directly into the ... in incredible ways. When you join Team Amex, you become part of a global and diverse community of colleagues with an unwavering commitment to back our customers,… more
- New Era LLC (Buffalo, NY)
- The Director /Sr. Director of Global Brand Protection manages and oversees New Era's global anti-counterfeiting / brand protection strategic objectives ... and criminal matters of counterfeit and unauthorized product throughout all New Era global markets and into all distributor markets. Provide expertise and lead and… more
- Dentsply Sirona (Charlotte, NC)
- …innovation. **Make a difference** -by helping improve oral health worldwide. The Global Audit Director position is responsible for providing leadership, ... Legal, Supply Chain, Commercial and Compliance to effectively deliver results. The Global Audit Director also has critical leadership responsibility for… more
- Amgen (Los Angeles, CA)
- …science that can turn the tide of serious, life-interrupting illnesses. **Executive Director , Global Development Lead- Xaluritamig** **Live** **What you will ... as well as: + Key regulatory/safety deliverables (eg, core labeling and global regulatory submission documents, periodic safety update reports) + Regulatory… more
- Georgetown Univerisity (Washington, DC)
- …in intellectual inquiry and making a difference in the world. Requirements Senior Director , Principal & Transformative Gift Operations - Office of Advancement - ... the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington,...the university, this team - led by the Senior Director , P&T Gift Operations - will help… more
- AbbVie (Irvine, CA)
- …medical device regulations, and desired experience in the CE Marking process, global regulatory strategy, and regulatory submission process. + Proven experience ... @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director of Regulatory Affairs - Soft Tissue Fillers MPS supports regulatory… more
