- Catalent (St. Petersburg, FL)
- Supplier Quality Regional Lead Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the ... development and manufacturing of new treatments for patients worldwide....Global Supplier Quality Management team, the Supplier Quality Regional Lead will be responsible for management and leading the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... efficacy and new product development , CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …EU SmPC, EU PL, CCDS, CCPL)for new products or products in the development phase. Independently lead cross functional teams through all labeling discussions ... companies, reinforcing the use and implementation of labeling best practices. Assist or lead the development of Standard Operating Procedures (SOPs) and process… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …advise on development strategies, and deliver on associated regulatory activities Lead the Global Regulatory Matrixed Team in defining and executing the global ... advanced degree is strongly preferred Minimum of 10 years drug development / FDA /regulatory related industry experience required Demonstrated knowledge of global… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe primary objective of the Small Molecule Analytical Research and Development (SMAR&D) team is to carry out R&D activities partnering across the ... network to enable process and formulation development .- In this position, the SMAR&D Director will set...In this position, the SMAR&D Director will set guidance, lead activities, and develop a team whose roles include… more
- Merck & Co. (Rahway, NJ)
- …Regulatory Affairs and Clinical Safety (GRACS) function of our company's Research & Development Division by:Developing an active engagement strategy with US FDA ... and company strategy.Providing quality advice to stakeholders creating optimal development , commercialization, and drug/delivery device supply strategies-Building our leadership… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the Oncology and Specialty Medicine portfolios, in alignment with the business strategy. Lead the PV inspection management activities by ensuring readiness, ... and strategic quality advice to the CSPV and key business function and collaborate with RD and Medical Affairs...management representative for all key health authority inspections (US FDA , EU EMEA, MHRA etc.,).Develop and maintain an effective… more
- Merck & Co. (Rahway, NJ)
- …our company's teams for meetings with FDA at any phase of drug development . Lead cross-functional efforts to prepare for advisory committees and may speak at ... all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact… more
- Lundbeck (Dallas, TX)
- …psychiatry. It is a very exciting time to join our team as we lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager, you ... lead the promotion of our infusion product, driving demand...must demonstrate strong capability in the following areas:ESSENTIAL FUNCTIONS: Business Planning & Account Leadership - Ability to use… more
- Novo Nordisk Inc. (Boulder, CO)
- …oligonucleotide products. Relationships This position reports to Senior Director, Chemical Development . Essential Functions Lead the development , ... production internally or at external CMO's Develop, mentor, and lead a team of process development chemists...A deep understanding of and ability to apply of GMP/ICH/ FDA regulations to process development strategies for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for JP representatives. As part of leading Regulatory Intelligence, this role will lead the development and implementation of a global approach (incl. processes, ... & Policy team, through direct and indirect line management, to identify and lead global corporate initiatives, ensuring that DS is prepared to meet new or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …both Novo Nordisk and the patient Manage budget for digital initiatives. Serve as business lead in vendor negotiation and management of digital solutions to ... About the Department The Clinical Development , Medical and Regulatory (CMR) department at Novo...interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan ... appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference on Harmonization (ICH)… more
- Merck & Co. (Rahway, NJ)
- …developing tailored testing strategy for unique combination products? Join our Company's Device Development team as Senior Engineer or Senior Scientist and be at the ... expertise in design verification & characterization testing for the development and commercialization of combination products, including prefilled syringes,… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …play a critical role in driving the execution of research and business development initiatives, ensuring operational excellence and fostering innovation across ... history of securing grants and partnerships; demonstrated success in driving business development initiatives leading to sustained revenue growth. This… more
- Tris Pharma (Monmouth Junction, NJ)
- …privately-owned biopharmaceutical company in the US with a focus on development and commercialization of innovative medicines that address unmet patient needs. ... and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance… more
- Novo Nordisk Inc. (Durham, NC)
- …establishing maintenance strategies, supporting maintenance excellence initiatives, SOP development ; establishing & maintaining positive working relationship with ... & service contracts. Relationships Manager or Senior Manager. Essential Functions Lead reliability program with implementation of projects focused on improving… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical ... appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference on Harmonization (ICH)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …registering, updating, managing lineage, and adding context metadata in a structured fashion Lead and work with functional business data stewards on data quality ... data governance effort by providing data stewardship guidance across the business functions including advocating for good data governance, stewardship, data… more
