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Online Resumes with "NDA"



Sr SAS Programmer

With 14 years in remote SAS development and Statistical Programming, I have gained invaluable expertise leading and contributing to summarizations of clinical trial results for pharmaceutical and biotech firms. I have been a “go to” SAS resource for Amgen, Cephalon, BD Medical Systems, Astra-Zeneca, Boehringer-Ingelheim, Smith-Kline & Beecham and Miami/Dade Water and Sewer Administration (WASA). I have successfully led mu...

Regulatory Affairs CMC Specialist/Manager

Tags for this Online Resume: CMC Data Analyst, Regulatory Affairs Specialist, CMC, FDA, Viewpoint, eCTD, NDA

looking for a exciting position in pharmaceutical/biotech company

To secure challenging full time position in the field of Pharmaceutics.To work in environment that provides opportunity for learning and growth and to carve a niche in whatever I undertake.

Tags for this Online Resume: Regulatory associate, reseach associate, validation, GXP, CFR, NDA-ANDA

Scientist / Sr. Scientist

Highly motivated Scientist with over 14 years of experience in research and drug discovery from target identification to development candidate in major pharmaceutical companies, healthcare, academic environments and food industry. Researcher with excellent oral/written communication and interpersonal skills and demonstrated leadership ability; Work diligently, both independently and as a key team member with innovative pro...

Tags for this Online Resume: Scientist , Biochemist, Pharmacology, Molecular Biology , Antibody/Biomarker, RNA- DNA-assays, CDM, Data entry, Data Monitor, Regulatory Affairs, IND, NDA

Regulatory affairs professional

Tags for this Online Resume: SOPs , Dossiers, COAs, e-submissions, NDA, INDA

Expert Biostatistician

Statistical analysis in pharmaceutical industry

Tags for this Online Resume: Biostatistics, SAP, FDA, NDA, ICH/GCP, SAS

Featured Profile

Featured Profile

Executive Assistant

Administrative Assistant with over 10 years’ experience with/as Life Science, Marketing/Sales Coordinator, Finance, Project Management, Customer Service domestic/international who excels as a professional in organizing and problem-solving to complete multiple deadline-driven projects efficiently and on time while independently, using the initiative to improve processes while working to meet organizational objectives ‘think...

Ideal Companies: Healthcare, Energy, New Start Ups, Agilent, Raytheon, HP, Philips

Tags for this Online Resume: Executive Assistant, Administrative Assistant, Marketing, Finance, Customer Service

Clinical Research Professional- 20 years experience- Memphis

Clinical research professional with over 20 years of experience in both industry and academia. Responsible for all audit activities for multiple phase 1-3 clinical trials. Responsibilities include but are not limited to ICH/GCP compliance. Reviews key study documents such as protocols, informed consents, CRFs, monitor reports, and CSR. Presents protocol and GCP training at Investigator meetings. Mentors and trains junior qu...

Tags for this Online Resume: GCP, FDA submission documents, Drug safety, GLP, NDA, Auditor

Featured Profile

Principal Scientist/Analytical Project leader

Seek position in R&D as a analytical development team leader handling multiple projects, coordinate project activities with various departments (quality assurance, Reg. CMC, Clinical Manufacturing Unit, Drug supply management, technical operations and outside contract laboratories. Direct analytical method development and oversee analytical development for the formulation development at contract labs

Tags for this Online Resume: Publications, Diagnostics, Pharmaceutical, Research, Research and Development, Support, Technical Support, Audit, Compliance, Medical

Featured Profile

Senior Vice President Sales & Marketing - Experience with startups and fortune 500 companies leading sales organizations. 15 years experience

Passionate, determined leader with a consistent track record of exceeding goals and introducing new solutions and software to key clients in highly competitive startup and Fortune 500 environments. An ethical hunter who enjoys prospecting, closing large deals, and creating long-term, win/win solutions for the company and its clients. “Go to” resource and trusted advisor for revitalizing sales operations and positioning star...

Ideal Companies: Companies that want to grow and service their customers.

Tags for this Online Resume: Sales & Marketing, Software solutions, Busness development, Leadership , New Market Penetration, Hunter

Senior Microbiologist

I'am a Senior Microbiologist who has over 11 years of experience in planning, executing and managing clinical and non-clinical studies in Microbiology required for IND or NDA by FDA; isolation and identification of microorganisms, antimicrobial susceptibility testing by CLSI approved procedures.