- Daiichi Sankyo, Inc. (Bernards, NJ)
- …summer and part-time (20 hours) for the remainder of the internship. Responsibilities:Support the Global Brand Director in the preparation and launch of the new ... frontline indication. Collaborate with cross-functional teams (Medical Affairs , Clinical, Regulatory , and Commercial Operations) and the alliance team to align… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …compliance activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality ... (eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …hours per week. Responsibilities: Daiichi Sankyo Inc's Oncology Publications team within Global Oncology Medical Affairs (GOMA) is seeking a Publications Systems ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...and Operations Intern to work closely with the Director of Publications Operations to optimize department resources for… more
- Eisai, Inc (Nutley, NJ)
- …also consider remote based.Eisai Salary Transparency Language:The annual base salary range for the Director , Global Regulatory Affairs , Growth Markets is ... your profile, we want to hear from you. The Director , Global Regulatory , Growth Markets...broad pharmaceutical industry experience, including 8 years of direct Regulatory Affairs experience with new/innovative drug registration… more
- Merck & Co. (Rahway, NJ)
- …required) - Functional Area: Regulatory Innovation and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS) - The ... implement user requirements, workflows, and metadata standards. Ensure compliance with global regulatory standards and internal SOPs for electronic submissions… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Regulatory Affairs , supports products in the Oncology therapeutic area as part of a regulatory team.- The ... Skills: Accountability, Adaptability, Biological Sciences, Cross-Functional Teamwork, Drug Development, Global Strategy, Innovation, Regulatory Affairs … more
- Merck & Co. (Rahway, NJ)
- …Skills: 10 years of experience in global patient advocacy and engagement activitiesUS/ global experience in regulatory affairs , medical and scientific ... Job DescriptionThe Executive Director and Global Lead, Patient Advocacy...in the Value & Implementation (V&I) organization, which includes Global Medical and Scientific Affairs as well… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... science or healthcare preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional experience in the… more
- Merck & Co. (Rahway, NJ)
- …marketing teams within the organization along with sales, product development, regulatory affairs , customer service, and other cross-functional teams to ... and ability to successfully partner cross functionally with all business units, regulatory , legal, and with Global Marketing colleagues Demonstration of computer… more
- Merck & Co. (Rahway, NJ)
- …of best practices in those areasU.S./ Global experience in clinical research, regulatory affairs , scientific and medical affairs , or pharmaceutical ... and Development Division, Value & Implementation Human Health, Manufacturing Division, IT Global Medical Proficiency and External Affairs (GMPEA) Global … more
- Eisai, Inc (Nutley, NJ)
- …to the health economics and outcomes research strategies, and timelines with medical affairs , marketing, managed markets and global value and access teams. ... difference. If this is your profile, we want to hear from you. The Director , US HEOR and RWE (field) is responsible for developing HEOR engaging population-based… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …with the rich experience they bring across varied skill-sets.We are proud that our global workforce is bound by our common values. **Job Summary:** Reporting to the ... Chief Commercial Officer, US Innovative Medicines, the Senior Director of Commercial Analytics and Insights will play a...and external vendors to ensure data integrity, privacy, and regulatory adherence. + Immersion in strategic and tactical plans… more
- Organon & Co. (Jersey City, NJ)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC,?the Associate...the product lifecycle.?? + Lead development and execution of global product and project regulatory strategy(ies) by… more
- Organon & Co. (Jersey City, NJ)
- …Dermatology Outcomes Research Epidemiology and Economics will report to the headquarters Director of Medical Affairs Outcomes Research. Core elements enabling ... priorities. Developing and implementing patient-centered endpoints strategies, working with regulatory , Value Strategy Assessment (VSA's) and contracting. The role… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional interactions with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, ... Manufacturing and Controls (CMC), medical affairs and business development are critical to the success...to inform mitigation strategies in accordance with regional and/or global regulatory requirements. + Actively participate in… more
- Organon & Co. (Jersey City, NJ)
- …of industry experience? in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.) + At least ... **The Position** We are looking for an experienced Associate Director , Program Manager to join our team. This successful...live their best lives. We are a $6.5 billion global healthcare company focused on making a world of… more
- Organon & Co. (Jersey City, NJ)
- … strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation ... Position** Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and...business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location:** Morristown, NJ Cambridge, MA **About the Job** Are you ... families. Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling Strategy… more
- J&J Family of Companies (Raritan, NJ)
- …Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director , Global Regulatory Affairs Diagnostics. This ... application. We invite candidates from any location to apply. The Associate Director , Global Regulatory Affairs Diagnostics will provide an opportunity… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As an Associate Director , Global Regulatory Affairs , you will act as ... Affairs and may serve as Regional Regulatory Lead or Global Regulatory ...current global and regional trends in biopharmaceutical regulatory affairs . Proven effectiveness applying this knowledge… more
