- DRT Strategies, Inc. (Silver Spring, MD)
- …comprehensive safety data analyses for new drug applications (NDAs) and biologics license applications (BLAs) in collaboration with clinical reviewers. Job Summary: ... The Clinical Data Scientist position interacts with many FDA stakeholders across several Offices and Centers specifically with clinical reviewers (Medical Officers) and statistical reviewers. This role will be responsible for reviewing safety data sufficiency… more
- Genentech (Hillsboro, OR)
- …aseptic processing principles, regulations, and industry guidelines relevant to biologics processing, including knowledge of quality assurance principles, quality ... systems, microbiology, and sterility assurance. + Your interactions exhibit tactful and effective communication skills as they often involve complex and sensitive information. + You are able to gown into production space. Preferred: + You have a Master's… more
- BeOne Medicines (San Mateo, CA)
- …with the FDA and prior experience with both small molecules and biologics + Thorough understanding of drug development process and the pharmaceutical industry ... and healthcare environment including regulatory requirements and policy trends + Extensive regulatory experience with INDs/CTAs, NDAs/BLAs, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and… more
- Polaris Pharmacy Services, LLC (Covina, CA)
- …degree. + Previous knowledge/experience with immunoglobulin infusion sales and biologics is preferred. + Current relationships with Neurology. Immunology, ... Dermatology, and Rheumatology a plus. + Minimum of 3 years of experience in pharmaceutical sales or a related field. + Proven track record of meeting or exceeding sales targets in a competitive market. + Experience in building and maintaining relationships… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …of advertising and promotion + Experience with pharmaceutical products required, biologics experience is a plus + Experience working directly/indirectly with the ... FDA, specifically OPDP/APLB is preferred + Ability to review promotional materials and interact with FDA OPDP/APLB and support launch products/campaigns, while maintaining excellent written/verbal communication skill when giving strategic regulatory advice +… more
- Takeda Pharmaceuticals (Boston, MA)
- …Advanced understanding of CI processes, methods, industry ethics and compliance, and specialty biologics is required, as well as bench strengths in CI execution for ... strategic-to-tactical recommendations. **How you will contribute:** + Proactively identifies strategic and tactical CI needs of brands and pipeline, establishing both long-range and short-term business impact. + Collaboratively prioritizes and builds a CI plan… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …Job Duties:** + Responsible for equipment setup and operation in a biologics processing environment for plasma derived pharmaceuticals. + Strict adherence to ... procedures and practices according to FDA regulations. + Strong emphasis on documentation according to FDA regulations. + Adhere to departmental corporate safety policies. + Responsible for facility and equipment cleaning. + All work is performed in a clean… more
- Merck (West Point, PA)
- …solid oral dosage forms (tablets, capsules, modified release formulations), biologics , vaccines, or specialty dosage forms inclusive of drug-device combinations. ... Therefore, sufficient knowledge in the above areas is critical. Additionally, they are expected to drive one of several focus areas within the team. Including but not limited to; vendor network strategy, vendor relations, shipping and logistics, operational… more
- Aston Carter (St. Louis, MO)
- …+ Managerial experience, ideally 3-5 years. + Experience in pharma or biologics operations. + Knowledge of GMP (Good Manufacturing Practices). + Experience using ... Experian (MDM system). Work Environment This position requires working 100% onsite from Monday to Friday during standard business hours, with flexibility on start time. Pay and Benefits The pay range for this position is $55.29 - $60.10/hr. Eligibility… more
- Fujifilm (College Station, TX)
- …Must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products. + Role model for company core values of trust, ... delighting our customers, and Gemba. **Physical Requirements:** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made… more