Hi, I am looking for candidates for the below positions. Let me know if you have anyone available.
Position 1:- Position:- Developer (Job Id:- 893863) Location:- Los Angeles, CA Duration:- 13 Months Description:- * Software development from design definition through integration. * Design documentation, coding, code integration. * Candidates will be working on the next generation of medical product. * Participates in Design and Code Reviews, Specifies, Designs, and Debugs, and Verifies Medical Applications Software, Participates in Software Requirements Specifications inspections. Necessary Skills:- * DOORS is a must, Embedded software engineer. * C language expert. * 10 years experience with successful development of embedded software applications with excellent communication skills. * Medical System design experience, Thread-X operating system experience are plusses. Required:- * Assembler, C, Windows XP and Undergraduate Degree. Desired:- * C#, MS Windows, CE, MS Project, and Graduate Degree. Position 2:- Position:- Hyperion Essbase Location:- San Francisco, CA Duration:- 2 Months + (extension if they like the work of the person) Skills:- * ASO cube * Excellent MDX development skills, optimize calculations Scope:- * Update and modifying 2 existing Essbase apps ( convert from BSO to ASO , add a dimension) Position 3:- Position:- Global Manufacturing Compliance (GMC) Consultant / CMC Regulatory Affairs Expert Location:- Peapack, NJ Duration:- 12 Months + Note:- * Face to Face interview required. * Pharmaceutical Experience is required * Masters Degree in Computer Science or related discipline is required Qualifications:- * Bachelors Degree in Chemistry, Pharmacy, Biology, Biotechnology, Drug Regulatory Affairs or other scientific discipline required. * Masters or Ph.D. preferred. * At least 5 years of broad based, manufacturing related regulatory and/or quality experience with demonstrated project management and interpersonal skills. * Successful candidates should have experience or working knowledge of change control practices and/or dossier preparation for manufacture of human pharmaceutical, biological and/or animal health products in global markets. * Qualified candidates must possess excellent communication skills (both written and verbal) with strong technical and regulatory writing ability. * Proven experience in multi-tasking and prioritizing projects. * Demonstrated negotiation skills involving complex technical issues and business priorities. * Process and detail oriented with the ability to follow complex processes and prepare large complex documents. * Strong global knowledge in post-approval Chemistry, Manufacturing and Controls (CMC) change regulations and in the content and structure of the CMC section of a Marketing Authorization (e.g. NDA, MAA, IRD, JNDA, DMF, CTD, ANDA, NADA, etc.). * Candidate must have a thorough understanding of regulatory change management requirements, possess a strong working knowledge of FDA regulations and other global authorities' regulatory requirements, demonstrated leader behaviors. * Ability to participate as GMC representative on cross-functional project and co-development teams, and effectively work with multiple disciplines and personalities. Responsibilities:- * Develop CMC regulatory post-approval filing strategies for global products. * Manage CMC regulatory changes and develop global filing strategy for human or animal pharmaceuticals or biologicals manufactured at Pfizer Manufacturing facilities and contract manufacturers. * Work with manufacturing sites and Center functions to facilitate the resolution of questions and/or issues throughout the change management review process. * Write scientific justification based on applicable regulatory guidelines and assembles variation package for manufacturing changes with regulatory impact including updated dossier sections. * Prepare responses to health authority queries and requests for CMC information as appropriate, in accordance with Pfizer policies, practices and procedures. * Prepare and archive variations/supplements, renewals or annual reports in electronic document systems. * Maintain fluency in existing and emerging global CMC regulations. * Provide CMC support to global market affiliates for license renewals and annual reports, line extensions and territory extensions. * Ensure that all CMC regulatory documents are prepared accurately, completely, on-time and submission ready (format/content). * May manage a portfolio of several products to prepare/maintain CMC sections of Marketing Authorization Applications. Thanks & Regards, Satwinder Singh Senior Sales Manager I Econosoft, Inc I Tel: (408) 228-0242 X 853 Toll Free : 1-800-566-4604 X 853 efax: (408) 324-1729 / 775-227-6817 Yahoo IM:- satwinder15 Email: [EMAIL PROTECTED] www.econosoftinc.com Anuj Kumar | Regional Manager | Ext 364 | Note: We respect your Online Privacy. This is not an unsolicited mail. Under Bills.1618 Title III passed by the 105th U.S. Congress this mail cannot be considered Spam as long as we include Contact information and a method to be removed from our mailing list. If you are not interested in receiving our e-mails then please reply with a "REMOVE" in the subject line and mention all the e-mail addresses to be removed with any e-mail addresses, which might be diverting the e-mails to you. We are sorry for the inconvenience. --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to the Google Groups "RESOURCE OPTIONS, INC." group. 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