Maha Kosa
Sr Analyst Preclinical Operations @Neurocrine Biosciences
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WORK HISTORY
Sr Analyst Preclinical Operations @Neurocrine Biosciences
San Diego, CA, US
EDUCATION
University of Arizona, Tucson, AZ
Master of Science - MS, Microbiology
University of Arizona, Tucson, AZ
Bachelor of Science - BS, Microbiology
SKILLS
ABOUT MAHA KOSA
Highly motivated Pharmaceutical scientist with extensive experience in clinical and pre-clinical outsourcing management and research in the Pharmaceutical/Biotech industry. Result achiever and agile thinker with a passion to succeed and meet goals. I have strong verbal and written communication & Interpersonal skills. I am highly respected among management and principal investigators for always achieving study goals and milestones. Tenacious for saving money, meeting critical timelines and providing quality data. I have excelled in teamwork both locally and globally through matrix relationships. Been recognized as an outstanding service provider and support in sourcing by receiving Individual Performance Award. I have impacted the success of many approved drugs while at Pfizer (Ibrance, Xeljanz, Xalkori, Macugen, Inlyta, Sutent) as well as at Agouron Pharmaceuticals (Viracept) by outsourcing hundreds of studies with CRO\'s. Specialties:Accomplished Outsourcing Manager with extensive experience overseeing and managing subcontracted projects for Fortune 500 organization to drive savings. Expertise in collaborating with multiple teams to determine proposal requirements, monitoring project budgets, and negotiating with vendors. Skilled at supporting contractual agreements and proposals while managing contractual obligations. Adept at achieving quality data and meeting deadlines. Strong communication and interpersonal skills. Successfully manage entire workflow with high levels of reliability, follow-up and completing work on-time.Clinical Contracts lifecycle management | Negotiation skills and vendor selection using RFI/RFP | Financial tracking/Metrics Analysis | Cross Functional Collaboration & Relationship Builder | Broad experience with CRO Management (national and international)| Clinical Development Process (Phase I, II, IIR/Collaborative studies | SOP/ICH guidelines/GXP (GCP, GLP & GMP)| Outsourcing clinical and pre-clinical studies (PK/TK/BA) monitoring/management | Multitasker & Problem Solver | Regulatory guidelines/requirements for document regulatory submissions | Data/Document Management Systems (GDMS & TMF).
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