Jobs in All Categories (20) Accounting & Finance (1) Engineering & Construction (2) Healthcare (5) Human Resources & Legal (2) Operations & General Management (1) Sales & Business Development (1) Science & Education (7) Technology (1)
Lead and coordinate corporate visibility efforts within the North American Medical Aesthetics Industry.
Act as Medical Monitor for Revance sponsored clinical trials and provide adverse event safety monitoring and reporting.
Clinical trials and new product submission documents, either in the specialty pharmaceutical or biopharmaceutical industry.
Works with Clinical Program / Study Managers, Lead CRAs, CRAs and CTAs to ensure consistency in processes across all programs and strict adherence to SOPs, regulations and guidelines.
Builds and maintains effective working relationship with cross-functional teams including Biostatistics, Data Management, and Clinical Operations
Serve as a key interface with internal business partners, Investigators and sites. Build and maintain contact and relationships with Investigators and clinical sites.
Optimization of assays, solid technical training and troubleshooting experiences are required.
Ability to work independently as well as within a team, handle multiple projects, demonstrate initiative and accountability, and strong attention to detail.
Collaborate cross-functionally to manage process characterization and process validation studies in-house or through vendors
Extensive hands-on experience with cutting edge high-resolution mass spectrometer for characterization of biologics, as well as LC/MS/MS method development for quantitation of proteins and peptides from complex matrices.
Designs and/or conducts pre-formulation, formulation development, process development, process optimization, scale-up and clinical manufacturing on assigned projects.
Works closely with quality groups to ensure strict compliance with good manufacturing practices guidelines at all times.
Present technical information to internal teams; represent the company externally through publications, presentations at scientific meetings and congresses.
Manages the planning and preparation of the adverse events section of protocols and informed consents for clinical studies.
Coordinate and communicate with DB vendors on consistent basis to address Clinical teams requests, project plans, and/or eCRF development activities.
Coordinate with third-party vendors and firms in completing certain tasks such as technical accounting matters, fair value remeasurements, external reporting, and compliance.
Develop a thorough selection and hiring process that yields quality candidates, speed of process, and a great candidate experience.
Aiding in the management and harmonization of contract templates, including developing new templates and updating existing templates in accordance with company guidelines and policies and/or Legal Department requirements.