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Were you looking for NDA-submission job results?
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Online Resumes with "NDA submission"
System Engineer
Experienced with CDISC SDTM (IG 3.1.2 and 3.1.3) and ADaM (IG 1.0) standards. * Created safety, and efficacy SDTM and ADaM datasets, summary tables, listings and graphs (TLFs). * Proficient at using SAS data step and procedures. * Experienced in generating Integrated Summaries of Safety and Efficacy (ISS, ISE). * Validated Analysis datasets and TLFs using parallel programming and other validation techniques. * Created new m...
Tags for this Online Resume: Active Directory Application Mode (ADAM), Base SAS, C Programming Language, C++ Programming Language, Catalogs, Communication Skills, Compliance, Data Analysis, Data Management, Database
Biostatatician
Accomplishments * Complete more than 100 studies including phase I to phase IV. * In charge of 20 phase I and 4 phase III study NDA submission tasks to ensure high quality deliverables that comply regulatory electronic submission guidance * Preparation of statistical analysis plans including mock up tables * Application of statistical section of clinical trial reports * Review of protocols/case report forms/statistical anal...
Tags for this Online Resume: SAS, Statistical Analysis, Documentation, Management, Pharmaceutical, Quality, Quality Assurance, Quality Control, Batch Processing, Biomedical Industry
In Between - 5 Years of Experience - Near 500081
Career Summary * SAS Certified Base for SAS9 with more than four years of experience. * Worked on different Phases of clinical trials and I have experience in programming, SDTM, ADAM and reporting in Clinical Research using SAS environments. As a Clinical SAS * Worked on Various Complicated SDTM domains like LB, MO & OE for ophthalmoscopy studies * Understanding of the study Documents and Data (e.g. Study design and objecti...
Tags for this Online Resume: A SERIES, Active Directory Application Mode (ADAM), Base SAS, Cardiology, Clinical Research, Data Management, Documentation, Generate Reports, HyperText Markup Language, Macro (Predefined Code)
Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality
Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...
Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.
Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA
Pharmacist - 20 Years of Experience - Near 60031
Seeking a position as a pharmaceutical strategic leader in project management or clinical operations.
Ideal Companies: Abbott, Abbvie, Astellas, Mead Johnson, Baxter
Tags for this Online Resume: Clinical Research, Research, Gastroenterology, Medical, Pharmaceutical, Cardiopulmonary resuscitation (CPR), Coaching, Diversity, Immunization, Management
