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Online Resumes with "Clinical Regulatory"
Clinical Regulatory Affairs
Tags for this Online Resume: labeling
Clinical Regulatory Affairs
Clinical Regulatory Affairs
Management experience in Regulatory Affairs Compliance and Submissions: Cross functional duties with Clinical Operations and Quality/Executive Committee.
Clinical Regulatory Affairs - 6 Years of Experience - Near 07203
To pursue a challenging career in Drug Regulatory Affairs and become a part of an esteemed organization where I can use my skills, understanding and experience to bring out the best results and contribute to the growth of the organization.
Tags for this Online Resume: Regulatory Affairs, Documentation, Management, Publishing, Document Management, Pharmaceutical, Publishing Experience, Quality, Quality Assurance, Quality Control
Regulatory Affairs, Quality, and Clinical Evaluation Consultant to Medical Device Industry
PROFESSIONAL PROFILE: A focused, driven, and passionate regulatory affairs and quality/compliance/auditing consultant with hands-on experience in RA and Quality/Compliance/Auditing associated with activities which lead to, and maintain regulatory approval to ISO 13485, FDA 510 (k), EU CE Mark & other international market authorizations of medical device products and conformance/compliance of Quality Management Systems. Regu...
Tags for this Online Resume: Management, Regulatory Affairs, Assessments, Audit, Budgeting, ISO, Microsoft Office, Quality, Quality Assurance, Quality Management, oncology, protocol, 13485, FDA, 483, Warning Letter, Portuguese, Spanish, ANVISA, Lead Auditor, Quality Systems, Quality Audit, Medical Device
Clinical Research - 5 Years of Experience - Near 19128
SUMMARY * Project coordination, document management and coordination experience in a clinical health environment in pharmaceutical industry. Worked for Spark Therapeutics, Baxter, Execupharm, United BioSource (an Express script company) and Liquent (a Parexel Company) * 3 + years of experience in Regulatory Affairs supporting the compilation of regulatory submission and assisting with the publication those submissions using...
Tags for this Online Resume: Documentation, Microsoft Excel, Microsoft Office, Microsoft Outlook, CVS, Distribution, Document Management, Documentum, Documentum (Wkflow Sw), Financial
Correspondence Clerk - 16 Years of Experience - Near 60085
PROFILE: Motivated, results-oriented Professional with extensive clinical and regulatory knowledge (Good Clinical Practices, Food and Drug Administration, The International Conference on Harmonization and other regulatory requirements), has 16 years experience in clinical support activities with a broad array of clinical database software programs. Possesses exceptional interpersonal skills to develop and foster working rel...
Tags for this Online Resume: Documentation, Filing, Database, Documentum, Documentum (Wkflow Sw), Support, Clinical Management, Management, Quality, Audit, Clinical Documentation
Clinical Regulatory Affairs - 6 Years of Experience - Near 92648
QUALIFICATIONS Document-Labeling Specialist, Nov.2015 - Feb.2016 Well-versed communicator, high organizational and analytical (Contract Position Only) abilities. Work well independently and as a member of a * Creation, Revision of CGL, pre-printed labels and IFU via team. Adept in SUSARs, IRB submissions, Sponsor redlining documents and SOP standards. monitoring, and CTMS files. Efficient at handling multiple regulatory doc...
Tags for this Online Resume: R programming, Word, Excel, Adobe Photoshop, Illustrator, google analytics, github, Adobe, Data Entry, Documentation, ISO
Contract Medical Writer
Summary Work Experience: Strong background in medical writing and biotechnology product and services development, with a solid publication record in the peer-reviewed medical literature in addition to biotechnology analyst articles-an unusual combination of medical writing expertise, analytical skills, data analysis, management experience, and medical knowledge. Participate in pre-clinical, clinical, and commercial research...
Tags for this Online Resume: Business Development, Cancer, Clinical Research, Medical Writer, regulatory science, biologics, drugs, medical device
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)
Medical Science Liaison - 17 years Experience - Dallas,TX
* Texas-based PharmD & licensed pharmacist with 20 years' medical/biotech/pharma experience. * Proven medical skills as a liaison, pharmacist, pharmacy director, and clinical coordinator. * 20 years' post-doctoral experience includes 10 as a medical science liaison 6 in sales. * 7 years in clinical trials and 3 in oncology while working either as an MSL or in a cancer center. Synthesizing, integrating, and communicating co...
Tags for this Online Resume: Medical, Medical Affairs, Patient Counseling, Pharmaceutical, Inventory, Pharmaceutical Industry, Sales, Science, Compliance, Evaluate, pharmaceutical
