- Formation Bio (New York, NY)
- …and AI driven pharma company differentiated by radically more efficient drug development . Advancements in AI and drug discovery are creating more candidate drugs ... because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach… more
- Insmed Incorporated (NJ)
- …the Role:We are seeking a highly experienced and visionary Vice President, Product Development - CMC, Small Molecules, to help us expand what's possible for patients ... As a senior leader, you will oversee drug substance and drug product development , analytical development , and combination product development . To be… more
- Insmed Incorporated (NJ)
- …the Role:We're looking for an Executive Medical Director of Ophthalmology, Clinical Development to help us expand what's possible for patients with serious diseases. ... Reporting to the VP, Clinical Development - Gene Therapy, the Executive Director will have responsibility to lead clinical programs across different diseases and… more
- Insmed Incorporated (NJ)
- …global regulatory strategies and plans to enable efficient, competitive product development for assigned programs. This role will provide regulatory input to ... global cross-functional project teams throughout product development and submission activities. The GRL will serve as the global regulatory lead for documentation… more
- Merck & Co. (Omaha, NE)
- …Divestitures, Documentations, Financial Compliance, Global Logistics, Global Supply Chain, International Trade Finance, IS Audit, Policy Development , Policy ... Company's Global Supply Chain Director, the Specialist will support the development and implementation of global trade compliance policies, procedures, and related… more
- Unknown (St. Louis, MO)
- The Deputy Director of Development , Individual Giving position at the client (OTSL) plays a crucial role in strategically expanding individual philanthropy for the ... by its world premieres and commitment to nurturing talent through various artist development programs. Reporting to the Director of Development & Campaign… more
- SMU (Dallas, TX)
- …of the University's small classes, meaningful research opportunities, leadership development , community service, international study and innovative programs. ... of Engineering, Meadows School of the Arts, Simmons School of Education and Human Development , Dedman School of Law, Perkins School of Theology and Moody School of… more
- Genmab (NJ)
- …optimize the design and delivery of clinical trials across Genmab's development portfolio. This role balances operational ownership of high-impact feasibility work ... In addition to executing feasibility assessments, they will support team development , thought leadership, and innovation in feasibility methodology, tooling, and… more
- Eisai, Inc (Nutley, NJ)
- …through in neurology and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably ... arising from benefits administration, negotiation of vendor agreements, and development and implementation of a governance framework. ResponsibilitiesPrivacy (80%)… more
- Merck & Co. (North Wales, PA)
- …Medicines. Our company's Neuroscience Medicines span all phases of clinical development (pre-clinical to post-licensure). With a focus on late-stage development ... Senior Director will manage the entire cycle of clinical development , including study design, initiation, execution,-monitoring, analysis, regulatory reporting,… more
- Genmab (NJ)
- …The Senior Manager, Biostatistics acts as a biostatistician supporting the clinical development of compounds as compound lead, primarily up until proof of concept, ... scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation and improve… more
- Insmed Incorporated (NJ)
- …for implementing the safety and risk management activities for clinical development ; be responsible for safety surveillance, risk management, and risk communication ... for assigned development products; perform medical assessment of individual adverse event...background in providing product defense before a national or international regulatory authority is a plus.Experience within the rare… more
- Merck & Co. (Rahway, NJ)
- …sciences inventions.-The position will support programs in all phases of development , from discovery through development and commercialization, and allows ... and interaction with major areas of the business including discovery, development , manufacturing and supply, regulatory, business development , commercial groups,… more
- Tris Pharma (Monmouth Junction, NJ)
- …a leading privately-owned US biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, ... addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in...immediate need for an experienced TEMPORARY Analytical Research and Development Scientist III. This is a temp to possible… more
- Merck & Co. (Rahway, NJ)
- …Training Materials: Create and maintain training content aligned with Global Clinical Development standards and Good Clinical Practices (GCPs) and End to End ... SOPs, policies, and regulatory requirements. - Defines and contributes to the development of training strategies for GCTO Regions - Deliver Training Sessions:… more
- Insmed Incorporated (NJ)
- …to the Head of Scientific Communications & Publications, you'll lead the development and implementation of global Medical Communications Strategy across regions. You ... in a matrixed organization. A core responsibility will be to co-lead the development and maintenance of scientific platforms and the strategic execution of aligned… more
- Eisai, Inc (Nutley, NJ)
- …management in both CTD format and non-CTD format.Experience of the Drug Development process and working with cross functional international /global project ... and oncology, with a strong emphasis on research and development . Our history includes the development of many innovative medicines, notably the discovery of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriate Standard Operating Procedures (SOPs), Health Authority regulations, International Conference on Harmonization (ICH) guidelines and local regulations, ... certain responsibilities to Study Manager(s) assigned to the study- Protocol Development , and Team Assembly-Contribute to and interface with different levels of… more
- Merck & Co. (Durham, NC)
- …of regulatory and customer inspections Provide compliance advice to site, development and commercial product teams Supports and continually enhance the ongoing ... Compliance knowledge and proficiency in interpreting and applying domestic and international regulatory requirements Knowledge of Quality Systems within a GMP… 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. ... We have more than 150 US and International patents including applications and have marketed several branded...mentors lower level technicians as appropriate Assists with the development and writing of SOPs and investigation reports and… more
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