- Formation Bio (New York, NY)
- …and marketing applications, and extend product registrations. Provides proactive guidance to internal groups based on technical and regulatory knowledge ... NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC guidance around drug development and manufacturing/supply processes Understands, interprets… more
- Formation Bio (New York, NY)
- …systems validation. The implementation of the QA strategy will involve leadership and guidance to the organization, along with building a team and maintaining up to ... and sites, providing support during health authority inspections, and offering guidance on quality issues. Ensuring vendors adhere to relevant quality programs,… more
- Biolife Plasma Services (Rochester, NY)
- …results. The Medical Support Specialist (Plasma Center Nurse) works under the guidance of the Center Manager (or Assistant Manager as applicable) for operational ... guidance and under the management of the Center Physician...or a manufacturing environment. The Medical Support Specialist follows guidance provided by BioLife Medical Affairs and provides center… more
- Merck & Co. (New York, NY)
- …cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".The ... salary range for this role is $187,000.00 - $294,400.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors… more
- Merck & Co. (Poughkeepsie, NY)
- …cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".The ... salary range for this role is $104,200.00 - $163,900.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors… more
- Cipla (Hauppauge, NY)
- …regulatory compliance requirements with an emphasis on US and EU/MHRA data integrity guidance . Ability to work as part of a cross-functional team in a dynamic, ... fast-paced environment. Ability to effectively communicate with team members, contractors and vendors. Employment Classification Full-time Location Hauppauge or Central Islip, NY locations Physical Requirements This position requires the ability to do heavy… more
- Formation Bio (New York, NY)
- …and scalability.ResponsibilitiesProject Management Oversight Provide strategic and tactical guidance for ongoing and newly launched clinical studies, ensuring ... alignment with corporate and asset development goals, timelines, and budget parameters. Maintain accountability for project deliverables, including overall timelines, budget forecasts, and resource allocation. Ensure all clinical trials comply with ICH-GCP,… more
- Cipla (Central Islip, NY)
- …chambers, etc. Strong knowledge on USP monograph requirements, FDA & ICH guidance requirements, etc. Effective interpersonal relationship skills and the ability to ... work in a team environment. Experience in Inhalation products (DPI) is a plus. Ability to work in a fast-paced, dynamic environment within a manufacturing operation setting. Must be able to communicate clearly and concisely across all levels of the… more
- Parexel (Albany, NY)
- …medical reviews, provide expert safety monitoring, and deliver pharmacovigilance guidance across assigned projects. You'll also mentor junior team members ... resolve case issues, coordinate with client therapeutic/legal team + Provide guidance to junior physicians on case assessment methodologies **Periodic reports (as… more
- QuickMD (Brooklyn, NY)
- …make informed, high-quality treatment decisions. Prescribe medications and provide expert guidance on their proper usage (QuickMD does not prescribe controlled ... substances, except for buprenorphine for opioid addiction treatment). Collaborate with physicians and nurse practitioners, experienced nurses, and a dedicated support staff to ensure comprehensive patient care. Maintain appropriate medical documentation to… more
