- BridgeBio Pharma (San Francisco, CA)
- Director / Sr . Director , Regulatory Affairs Calcilytix San Francisco, CA/Hybrid Regulatory Affairs Calcilytix Therapeutics, an affiliate of BridgeBio ... Canada, and Zurich, Switzerland, and are expanding across Europe.This experienced regulatory professional will have demonstrated the ability to work independently or… more
- Merck & Co. (North Wales, PA)
- …process including the related SOPs and Execution resources. The incumbent is accountable to Sr . Director of Business Process and Systems with input from VP, CSRM ... external stakeholders, contributing functional areas and process governance committees. Works with Sr . Director for Business Process and Systems, -CSRM to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction with ... Medical Writing- Leads scientific components of IM (Investigators Meeting) and SIV (Site Initiation Visit) Training: compound, Diagnosis (Dx) Overview, in collaboration with Clinical Scientists (CS)- Interpretation and presentation of clinical study(ies) data… more
- Tris Pharma (Monmouth Junction, NJ)
- …to hear from you.We are hiring at our Monmouth Junction NJ Headquarters for a Senior Director to lead our small, but productive, Marketing team.The Senior ... and programs are in full compliance with Medical, Legal, Regulatory and Corporate guidelines; Establishes, oversees implementation, and monitors adherence… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- Merck & Co. (North Wales, PA)
- …, GLOBAL REGULATORY CMC Biologics (R5)Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is ... of internal regulatory strategies and provides mentoring and coaching to Sr . Scientist and Assoc Principal scientist in support of their assigned projects.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other ... regions. This position ensures alignment of regulatory strategies within the department and adherence to therapeutic area direction and corporate objectives. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary Sr . Director Data Management contributes to the vision, direction and ... Additionally, this position recommends and executes strategies in collaboration with Senior Management and global stakeholders that are optimized across business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global RD and PV QA organizational strategy in collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy and Operations. In ... collaboration with the Associate Director Global Strategy and Operations and Head Global Strategy...team lists and track projectsProvide Strategy Operations support for regulatory inspection related activities as required such as ensuring… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with decision-makers across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines. You… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Key Opinion Leaders (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical Director in ... Area in certain instances, at the discretion of Executive Director of Medical Affairs. Assists the Senior ...Nordisk portfolio. Relationships This position reports directly to the Sr . Director , Medical Affairs and will assist… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring CMC… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director / Senior Director , Clinical Quality Assurance. This is a hybrid ... Title commensurate with experience.SUMMARY:Reporting to the Chief Quality Officer the Senior Director of Clinical Quality Assurance provides strategic leadership… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an ... the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in conjunction… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development plans, clinical protocols, and in submission of certain regulatory documents. Responsibilities:Develop and implement a hypothesis driven translational ... defining key scientific questions and plan. Align closely with the Senior Translational Strategy Lead.Construct translational plan documents, biomarker data analysis… more
- Eisai, Inc (San Diego, CA)
- …is your profile, we want to hear from you. Job Summary The Sr . Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting Oncology ... internal cross functional partners including but not limited to Associate Director Regional Marketing, Oncology Field Reimbursement Managers, and other specialty… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needs and the respective development stage of the project. The CMC Lead will support the Sr . CMC Lead on complex and/or late-stage project or act as main CMC Lead of ... and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status and potential...lead teams within overall CMC development project(s), to support Sr CMC Lead. In case no Sr … more
- Eisai, Inc (Louisville, KY)
- …is your profile, we want to hear from you. Job Summary The Senior Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting ... within an assigned territory in a compliant and appropriate manner. The Senior Oncology Sales Specialist represents and promotes assigned brand(s) in the oral… more
- Merck & Co. (Washington, DC)
- Job DescriptionPosition Description: Associate Director , Policy Strategy and Capabilities The Associate Director , Policy Strategy and Capabilities is ... the Strategic Planning & External Engagement team, reporting to the Executive Director , Policy Development & Strategy.The Associate Director will develop and… more
