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Online Resumes with "NDA"



Pharmacist

Tags for this Online Resume: Regulatory submission, CMC, cGMP, Compliance, Regulations and Guideline, US FDA, medical device, IND/NDA/ANDA

Physical Scientist - 20 Years of Experience - Near 10926

Over twenty years experience in executing pharmaceutical product development initiatives. Proven ability to take product prototypes from R&D development through scale up and final marketplace introduction. In depth knowledge of GMP's, GLP's, NDA and IND requirements. Proven skill in managing technical staff and advancing projects.

Tags for this Online Resume: Formulation, Drug Delivery Technologies, Pharmaceutics, Pre formulation, Liposome, Nano technology, Polymers, colloids

Contract Administrator - 4 Years of Experience - Near 95134

• Transactional lawyer experienced in negotiation and drafting complex commercial agreements. Manage, draft and negotiate all forms of Company contracts, including - Professional Services Agreements, Service Level Agreements, Partner and Vendor Agreements, Employment agreements, license grants and acceptable use, NDA, intellectual property right protection, indemnification, limitation of liability, and compliance with laws....

Tags for this Online Resume: Contracts Negotiator, Contracts Manager, San Francisco , drafting, contracts administrator, agreements, contracts, legal

Clinical Research - 20 Years of Experience - Near 33406

• Clinical Research Consultant with over 28 years of Pharmaceutical/Biotech experience including Phase I – III clinical trial development with direct involvement in multiple FDA/ICH submissions leading to six NDA approvals. • Extensive monitoring domestically and internationally, training and mentoring innumerable CRAs/Monitors in the field which lead to further training responsibilities with Study Teams and Management Te...

Tags for this Online Resume: Florida, Pharmaceutical Research, Monitoring, Management, Team Building

Quality Assurance Specialist - 12 Years of Experience - Near 20902

Featured Profile

Purchasing Agent - 15 Years of Experience - Near 19901

Experienced in Purchasing Management, Account and Contract Management, Negotiations. Seeking a Procurement position in Delaware. Willing to relocate to Delaware to be closer to family.

Tags for this Online Resume: Contract MGT, Technical, Project MGT, Process Improvement, Training, Account MGT, NDA Negotiation, Health Insurance

Clinical Quality Assurance - 20 Years of Experience - Near 94403

QA/QC experience working with FDA ICH and Japanese regulations 21 CFR reviewing Writing editing submission documentation SOPs Protocols Reports. Product/Project analytical requirements evaluation budget in-house vs. out-source estimation. Upgrading of R&D laboratories to GLP/GMP level.

Ideal Companies: small start-up company

Tags for this Online Resume: methods transfer validation, phase I, II, III protocols and reports, GMP GLP, Laboratory management, hiring training budgeting, FDA ICH regulations, validation monitoring transfer, medical devices, Consulting, Document Review, Documentation, DSC, High Performance Liquid Chromatography (HPLC)

Sales Manager - 15 Years of Experience - Near 00060

to use my professional experience in the frame of an international organization. I posses strong negotiation skills, international business knowledge, M&A, MOU, NDA, TAA, License agreements drafting negotiating and implementing experience.

Tags for this Online Resume: law degree, defence aerospace, contracts M, compliance , international, IACCM, TRACE certification

Lawyer - 17 Years of Experience - Near 11783

I most recently served as Director of IT Contracts (IT Counsel) for North Shore-LIJ Health System, the 3rd largest, non-profit healthcare system in the US consisting of more than 60,000 employees, 19 hospitals, an insurance company, medical school, over 400 ambulatory and physician practices and 70 affiliated facilities with an operating budget of nearly $8 Billion counseling executive management including the Chief Informa...

Tags for this Online Resume: Privacy, CIPP, Contracts, Procurement, Counsel, COPPA, HIPAA, IP

Pharmaceutical Quality Assurance Specialist- 10 years Experince- Atlanta

Seeking a challenging assignment in Quality Assurance in the pharmaceutical sector to utilize acquired expertise and deliver best-in-class results. PROFESSIONAL SNAPSHOT: •A Quality Assurance Professional bestowed with 10+ years of experience in Corporate Quality Assurance, Plant Quality Assurance, Manufacturing, Validation and different International Quality audits in Solid Dosage. •Hands on experience with Quality Manage...

Tags for this Online Resume: QMS, Batch Record Review, Preparation of SOP, CAPA, Investigation, Change Control, Deviation, Internal Audit, Document Control, Batch Release, Solid Dosage, Process Validation, APQR, Market Complaint, GMP, OOS, Self Inspection, Third Party Audit

Featured Profile

Chief Financial Officer - 20 Years of Experience - Near 75087

The Substance abuse facilities offering treatment in multi modalities. I report to the CEO and am responsible for all financial and non-clinical departments, including Accounting, Administration, Client Accounting, MIS, Dietary, Facilities, Housekeeping, and Human Resources. Responsibilities include Board reporting, Banking, Grant and Contract fiscal management, Cash Management, and Regulatory Compliance. The Water Store - ...

Ideal Companies: Hospitals, Clinics, Physician Practices, Credit and Collections

Tags for this Online Resume: Accounting, Cash Management, Financial, Housekeeping, Human Resources, Management, Accounts Receivable, Accounts Receivable, Receivables, Practice, Hospital, Reports

Medical Office Manager - 1 Years of Experience - Near 02120

Seeking a position to utilize my skills and abilities in the corporate sector that offers professional growth which is being resourceful, innovative and flexible. Knowledge of ICH guidelines and safety reporting requirements, good manufacturing practices (GMP), good laboratory practice (GLP) and good clinical practices (GCP). Understanding of FDA regulations and knowledge of IND, NDA, BLA, Drug Master File (DMF), 510(k) and...

Tags for this Online Resume: Boston, GLP, GCP, FDA Regulations, Medical Device