http://biospectrumasia.ciol.com/rss/ BioSpectrum Asia is a specialized information platform for life science articles in the Asia Pacific that includes life sciences articles, pharma news, life science products reviews and other information en-us 9/2/2010 5:30:04 PM 9/2/2010 5:30:04 PM http://biospectrumasia.ciol.com/rss/ BSA jobs feed generator sureshn@cybermedia.co.in webmasterciol@cybermedia.co.in http://biospectrumasia.com/JobDetails.asp?jobId=10920 Requisition ID 23285BR Job Category Biotechnology/Pharmaceutical Locations USA - Battle Creek, MI Shift 1 Job Posting GENERAL PURPOSE AND SCOPE: • Analyzes samples and/or develops/validates methodologies for various compounds and components in compliance with SOPs and regulatory agency guidelines. ESSENTIAL JOB DUTIES: • Organizes and conducts routine analyses in compliance with applicable methods, protocols, SOPs, and regulatory agency guidelines. • Documents work and maintains study documentation and laboratory records. • Sets up, operates and performs routine and non-routine maintenance on general equipment. • Provides input and participates in project meetings, plans, monitors and guides project work. • Performs QC review of data. • Informs Study Director, Principal Investigator and/or management of any problems and/or deviations that may affect the integrity of the data and participates in corrective action of problems. • Contributes towards a cohesive team environment. • Assists in setting up and performing method development and validation of various analytes in a variety of matrices. • Maintains a clean and safe laboratory work environment. • Performs other related duties as assigned. OTHER JOB DUTIES: • Trains and assists less experienced staff. • Participates in process improvement initiatives. • Participates in client visits as needed. • Evaluates data for report preparation and experiment modification as directed. • Plans individual workload in coordination with team members. • Assists in writing text for reports, methods or protocols. SPECIAL FACTORS • May work with potentially hazardous substances and/or radioisotopes. • Mandatory immunizations and screening as required. • Overtime and weekend work as required. GUIDELINE FOR PROMOTION: • Demonstrates consistent and sustained capability/willingness to perform at the Research Assistant II level. • Independently conduct tests for chemistry projects and provide initial analysis of results. • Is a technical resource for the department (trouble shooting, method development, qualification, maintenance and training). • Independently maintains and operates laboratory equipment, including independent problem identification and resolution. • Evaluates data for incorporation into written reports. • Completes project assignments on time with minimal supervision. • Knowledgeable on a variety of study types, analysis procedures and methodology. • Able to effectively communicate, both verbally and in writing. • Effectively interacts with internal and/or external clients. • Acts as a project leader. BS/BA degree in science or related field plus 1-2 years of previous laboratory experience, AAS degree and 3-4 years experience, HS degree and 5-6 years experience. 1- 2 years related or relevant laboratory experience required with a BS/BA degree or 3 - 4 years experience with an AAS degree. Familiar with the use of standard laboratory equipment (e.g., balances, pipettes, centrifuges) and analytical instrumentation is desired. Independently conduct tests for chemistry projects and provide initial analysis of results, asking questions as needed. Maintain and operate laboratory equipment, including independent problem identification and resolution. Able to effectively communicate, both verbally and in writing. Analytical instrumentation experience in HPLC, GC and ICP is desirable MINIMUM EDUCATION/EXPERIENCE/SKILLS/REQUIRED LICENSES OR CERTIFICATIONS: • Familiar with the use of standard laboratory equipment. • Analytical instrumentation experience in HPLC, GC and ICP is desirable • Basic knowledge of computers and software programs. Familiar with the use of standard laboratory equipment and analytical instrumentation(HPLC, UPLC, IC and GC) is desired. Independently conduct tests for chemistry projects and provide initial analysis of results, asking questions as needed. Maintain and operate laboratory equipment, including independent problem identification and resolution. Able to effectively communicate, both verbally and in writing. BS/BA degree in science or related field plus 2-3 years of previous laboratory experience, AAS degree and 3-4 years experience 9/2/2010 4:24:44 PM http://biospectrumasia.com/JobDetails.asp?jobId=10920 http://biospectrumasia.com/JobDetails.asp?jobId=10919 Requisition ID 23143BR Job Category Sales/Marketing Locations USA - Midwest USA - West Shift 1 Before drugs, chemicals, or foods can be sold, they must be evaluated for safety and effectiveness. Covance provides international testing services to clients in the pharmaceutical, food, biotechnology and chemical services industries. We are looking for qualified sales professionals to support our cGMP Pharmaceutical Analysis and Biotechnology service offerings. Working knowledge of cGMP analytical requirements for small and large molecule therapeutics. Experience in supporting release and stability testing of clinical supplies and commercial products. History of success with pharmaceutical clients in north America, especially Midwest and western US. Achieve agreed orders and revenue targets for a defined account base •Sells multiple services to assigned accounts •Sets and manages customer expectations •Recognizes and communicates opportunities for other business units •Collaborates with company wide resources to achieve superior client satisfaction •Reviews and qualifies all sales leads and filters them to appropriate sales rep. •Reviews external resources (e.g. industry publications) for leads •Manage sales process for defined new and existing client accounts •Build sustainable business relationships with clients'' R&D key decision makers (scientists and procurement / outsourcing specialist) • Create and communicate execute account and country business plans to achieve agreed business results • Manage customer relationship management process for defined account and geography • Account team co-ordination and communication •Harness and co-ordinate Covance resources to achieve account strategy through a focused account team approach. •Dynamic maintenance of customer database •Provides weekly sales activity reports and monthly sales review to management. •Develops client call cycle to achieve objectives and sales plan. •Provides general intelligence on key competitors. •Hosts and organizes all new client visits. •Evaluates all quotations for territory and provides input to guarantee client and company requirements are met. * Other industry segments considered: hospital account management (pharmaceutical, medical devices or capital equipment); laboratory equipment sales.) * Basic knowledge of Drug Development industry * Skilled in performing presentations and leading meetings. * Skilled time management, planning and budgeting. * Negotiation skills Life Sciences degree 9/2/2010 12:47:55 PM http://biospectrumasia.com/JobDetails.asp?jobId=10919 http://biospectrumasia.com/JobDetails.asp?jobId=10918 Requisition ID 23285BR Job Category Biotechnology/Pharmaceutical Locations USA - Battle Creek, MI Shift 1 Job Posting GENERAL PURPOSE AND SCOPE: • Analyzes samples and/or develops/validates methodologies for various compounds and components in compliance with SOPs and regulatory agency guidelines. ESSENTIAL JOB DUTIES: • Organizes and conducts routine analyses in compliance with applicable methods, protocols, SOPs, and regulatory agency guidelines. • Documents work and maintains study documentation and laboratory records. • Sets up, operates and performs routine and non-routine maintenance on general equipment. • Provides input and participates in project meetings, plans, monitors and guides project work. • Performs QC review of data. • Informs Study Director, Principal Investigator and/or management of any problems and/or deviations that may affect the integrity of the data and participates in corrective action of problems. • Contributes towards a cohesive team environment. • Assists in setting up and performing method development and validation of various analytes in a variety of matrices. • Maintains a clean and safe laboratory work environment. • Performs other related duties as assigned. OTHER JOB DUTIES: • Trains and assists less experienced staff. • Participates in process improvement initiatives. • Participates in client visits as needed. • Evaluates data for report preparation and experiment modification as directed. • Plans individual workload in coordination with team members. • Assists in writing text for reports, methods or protocols. SPECIAL FACTORS • May work with potentially hazardous substances and/or radioisotopes. • Mandatory immunizations and screening as required. • Overtime and weekend work as required. MINIMUM EDUCATION/EXPERIENCE/SKILLS/REQUIRED LICENSES OR CERTIFICATIONS: • Familiar with the use of standard laboratory equipment. • Analytical instrumentation experience in HPLC, GC and ICP is desirable • Basic knowledge of computers and software programs. GUIDELINE FOR PROMOTION: • Demonstrates consistent and sustained capability/willingness to perform at the Research Assistant II level. • Independently conduct tests for chemistry projects and provide initial analysis of results. • Is a technical resource for the department (trouble shooting, method development, qualification, maintenance and training). • Independently maintains and operates laboratory equipment, including independent problem identification and resolution. • Evaluates data for incorporation into written reports. • Completes project assignments on time with minimal supervision. • Knowledgeable on a variety of study types, analysis procedures and methodology. • Able to effectively communicate, both verbally and in writing. • Effectively interacts with internal and/or external clients. • Acts as a project leader. Familiar with the use of standard laboratory equipment and analytical instrumentation(HPLC, UPLC, IC and GC) is desired. Independently conduct tests for chemistry projects and provide initial analysis of results, asking questions as needed. Maintain and operate laboratory equipment, including independent problem identification and resolution. Able to effectively communicate, both verbally and in writing. BS/BA degree in science or related field plus 2-3 years of previous laboratory experience, AAS degree and 3-4 years experience 9/2/2010 12:00:52 AM http://biospectrumasia.com/JobDetails.asp?jobId=10918 http://biospectrumasia.com/JobDetails.asp?jobId=10917 Requisition ID 22992BR Job Category Sales/Marketing Locations USA - West GENERAL PURPOSE AND SCOPE: •To develop new accounts, new business opportunities at existing accounts and new market opportunities, using all to generate revenue for CLNA. ESSENTIAL JOB DUTIES: •Achieves annual sales plan. •Manages annual expense budget. •Develops account plans and partnerships with key accounts. •Provides weekly sales activity reports and monthly sales review to management. •Develops client call cycle to achieve objectives and sales plan. •Provides general intelligence on key competitors. •Participates in corporate teams to build relationships with key accounts and KADS. •Assists in determining margins and pricing with Client Services. •Hosts and organizes all new client visits. •Prepares weekly report based on template format provided by management. •Evaluates all quotations for territory and provides input to guarantee client and company requirements are met. •Assists in creating new market opportunities for Covance Labs and Covance Corporate. •Interaction with SBU Sales Specialists to jointly drive revenue. •Performs other duties as assigned. • Effective oral and written communication skills. • Skilled in negotiating sales contracts. • Knowledge of domestic and international registration data requirements desired. • Knowledge of computers (Word, Excel , GroupWise). • Knowledge of Key Accounts (or ability to gain familiarity quickly based upon previous experience). • Effective oral and written communication skills. • Skilled in negotiating sales contracts. • Knowledge of domestic and international registration data requirements desired. • Knowledge of computers (Word, Excel , GroupWise). • Knowledge of Key Accounts (or ability to gain familiarity quickly based upon previous experience). BS degree in chemical/biological science plus 7 years of experience in life science, contract research, or pharmaceutical sales. 9/1/2010 11:57:14 PM http://biospectrumasia.com/JobDetails.asp?jobId=10917 http://biospectrumasia.com/JobDetails.asp?jobId=10916 Requisition ID 23336BR Job Category Finance/Accounting Locations USA - Indianapolis, IN Essential Functions 1. Prepare and coordinate monthly management reporting and analysis. 2. Manage and track accuracy and completeness of transportation events – procure-to-pay and record-to-report. 3. Assist in preparation of transportation accruals and manual billing files. 4. Manage and track Global Unmatched Transportation Reporting and assist team with issue resolution. 5. Continually advance visibility and sources of transportation events - analyze and report on these events. 6. Work closely with logistics and other operational areas to ensure that financial implication of logistical decisions are identified. 7. Work with Client Services and Logistics departments to ensure that current pricing reflects current trends in investigator performance and shipping patterns, and provide recommendations on possible gaps. 8. Assist Global Controllers to identify and investigate perceived inconsistencies between, and understand changes in, transportation revenue and expense. 9. Assist Planning team with forecasting transportation revenue and expense. 10. Develop Finance processes, controls, and documentation related to transportation activity. 11. Develop and distribute key messages regarding the effects of logistical decisions on study budgets, presenting to senior management and sales executives where applicable. 12. Provide back up to Transportation System Leader 13. Assist with completion of Transportation Matching, Billing, and Data Warehousing Project. . •Knowledge and ability to use and create database and spreadsheet packages (i.e. Excel, Access, SQL, etc.). •Ability to give and follow written and oral instructions, as well as be self-driven to achieve company and departmental objectives. •Ability to interact with employees of a variety of developmental and socio-cultural backgrounds. •Outstanding verbal and written skills with exposure to senior management. BA or BS degree in Finance or Accounting or related field. Preferred • CPA, MBA, Masters in related field. 9/1/2010 11:53:12 PM http://biospectrumasia.com/JobDetails.asp?jobId=10916 http://biospectrumasia.com/JobDetails.asp?jobId=10915 Requisition ID 19064BR Job Category Sales/Marketing Locations USA - Princeton, NJ Essential Job Duties: •Build deep customer relationships for our most committed strategic clients by maintaining and developing client communications •Develop and execute the account strategic plan, driving the growth, growth in sales and increases in revenue and general profits across business unit lines •Manage communication pathways both with the client and within Covance for the client, to ensure internal and account alignment •Manage cross functional teams within Covance, across business units and internal departments, for delivery of services to the client •Develop innovative solutions, using total Covance resources, to address and solve customer challenges and requests •Manage Governance •Ensure account operational and service excellence and client satisfaction •Leverage the resources within SP&IDD Should be self motivated and professional A PhD or MD is preferred. 9/1/2010 11:49:47 PM http://biospectrumasia.com/JobDetails.asp?jobId=10915 http://biospectrumasia.com/JobDetails.asp?jobId=10914 Requisition ID 20761BR Job Category Finance/Accounting Locations USA - Princeton, NJ Maintain financial controls and reporting requirements to satisfy the needs of the Executive Team, the Board of Directors, analyst and regulatory agencies Work closely with outside auditors to establish a partnership that ensures Company is fully compliant with Sarbanes Oxley, US GAAP, IFRS and all the financial requirements of a public company. Work closely with business leaders to ensure that financial data is accurate and timely so that they can make informed business decisions. Utilize experience with financial systems to leverage the new company wide accounting system (FSA) and use this information to help drive efficiencies throughout the organization. Monitor outside events regarding accounting and SEC reporting matters and evaluate their impact on the Company; make recommendations regarding the findings to the CFO. •Lead the Corporate Accounting Team (@20 employees); ensuring that the team operates collaboratively and can also function effectively within the various business units, providing support to business leaders. •Coach and train the finance management team and establish and monitor succession planning. •Communicate and support the new structure and vision of the finance organization Required: •The selected candidate must have global experience as a controller of a $500+ million public company or as a divisional controller in a similar sized business, •In-depth knowledge of financial reporting, acquisitions experience and a history of working in a global organization. •Development and execution of policies and procedures that ensure strong internal financial controls. •Experience managing external audit firms. •Strong financial acumen with the ability to solve complex problems. •Strong ERP knowledge of automated financial and accounting reporting systems including, Oracle, Hyperion and PeopleSoft. •Ability to motivate teams to produce quality materials within tight timeframes and simultaneously manage several projects. •Executive presence including excellent oral and written communication skills. •Previous experience working in a public accounting firm is a must. Education/Qualifications Bachelor''s degree in Accounting, Finance or related field of study along with a current CPA license. 9/1/2010 11:46:22 PM http://biospectrumasia.com/JobDetails.asp?jobId=10914 http://biospectrumasia.com/JobDetails.asp?jobId=10913 Requisition ID 21897BR Job Category Information Technology Locations USA - Princeton, NJ Overall responsibility of ICC & BICC Provides strategic & thought leadership to the business, IT Leadership Team, & project teams on how these technologies should be leveraged to drive business value. Defines Integration & BI enterprise platform lifecycle plans & roadmaps, anticipating business needs, & developing business cases for such platform expansions/investments. Drives overall enterprise Integration & BI strategies & facilitates & coordinates consistent usage & deployment across business units through a common architecture & framework to promote re-use, speed of delivery & optimal TCO. Set the technical vision & direction for gathering, storing, & presenting data to support decision-making & analytics, for both internal users & external customers leveraging best practice data warehousing concepts & various methods such as web services, publish & subscribe models. Set technical vision & direction, leadership & expertise for key initiatives in the area of application integration using best practice integration frameworks & methods such as web services, SOA, publish & subscribe models. Plans, organizes & drives Integration & BI teams across multiple projects to achieve on-time, on-budget deliveries & adherence to reference architecture & standards. Ability to recognize deficiencies & prioritize & implement effective solutions. Promotes & enforces synergies between various programs & Covance businesses. Owns Competency Center budget management, total Cost of Ownership for the platforms, & cost benefit analysis. Allocates, directs & monitors performance of ICC & BICC resources. Oversees successful support of solutions on the ICC & BICC platforms meeting SLA''s. Defines & owns funding & recovery model for the respective competency centers & platforms. Defines, documents & promotes Competency Center artifacts including governance, best practices, methodology, delivery patterns & frameworks, change management, version control & release management, etc to ensure repeatable, high-quality, cost-effective deployments of solutions. Manages client interaction & expectations regarding integration & business intelligence efforts. Oversee negotiation & administration of vendor, outsourcer, & consultant contracts & service agreements. Manage IT staffing, including recruitment, supervision, scheduling, development, evaluation, & disciplinary actions. Remains on the forefront of emerging industry practices Up to 20% travel required to support projects. Strong influencing skills and teamwork skills Excellent verbal and written communication skills; delivers engaging, informative, well thought out presentations Analytical abilities, strong judgment and management skills, ability to work effectively with customers and IT Leaders. B.A./B.S. in related IT discipline is required. M.S./M.B.A. in related discipline is preferred. 9/1/2010 11:42:25 PM http://biospectrumasia.com/JobDetails.asp?jobId=10913 http://biospectrumasia.com/JobDetails.asp?jobId=10912 Requisition ID 23155BR Job Category Sales/Marketing Locations USA - Princeton, NJ Shift 1 Essential Job Duties: •Build deep customer relationships for our most committed strategic clients by maintaining and developing client communications •Develop and execute the account strategic plan, driving the growth, growth in sales and increases in revenue and general profits across business unit lines •Manage communication pathways both with the client and within Covance for the client, to ensure internal and account alignment •Manage cross functional teams within Covance, across business units and internal departments, for delivery of services to the client •Develop innovative solutions, using total Covance resources, to address and solve customer challenges and requests •Manage Governance •Ensure account operational and service excellence and client satisfaction •Leverage the resources within SP&IDD •Fluency in French is required This role requires experience in building, managing and growing customer relationships, as well as a deep understanding of industry dynamics, drug development and Covance''s service offerings. A PhD or MD is preferred. Fluency in French (spoken and written) is required. 9/1/2010 11:38:36 PM http://biospectrumasia.com/JobDetails.asp?jobId=10912 http://biospectrumasia.com/JobDetails.asp?jobId=10911 Requisition ID 21947BR Job Category Clinical Research Locations USA - Princeton, NJ Responsibilities include the following: • Responsible for the management of site start-up activities • Provide local leadership in the development and implementation of the CDS P3 (Predictive + Proactive + Preventative) model and in the direct supervision of staff concerned with site start up activities and project feasibility • Work with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organizations to develop evidence-based plans for the successful implementation and conduct of global clinical trials. • Assure that pre-study, drug supply and labeling processes comply with applicable guidelines and regulations and fulfill client and Covance requirements. • Supervise GSS staff in performance of their day to day work, including management of resource allocations • Provide logistical support for clinical trial supply coordination • Provide GSS input into business development activities • Direct line management responsibility for GSS team members: the recruitment, training/development, allocation, supervision, utilization and performance review of assigned personnel • Lead global project teams and global department members regarding issues of compliance with ICH/GCP, project plans, and Covance SOPs • As required, fulfill the role of start-up manager and oversee coordination of study activation components of the project from an oversight level including Feasibility, Site selection, Site Activation, Labels/Supply, Regulatory Submission, Green light • Provide day to day guidance so as to efficiently and effectively collect, analyze and interpret feasibility data to allow for the development of evidence-based planning associated with the implementation and conduct of clinical trials • Anticipate and monitor project requirements and institute appropriate actions to ensure timelines and budget needs are met • Serve as primary liaison between GSS and operational project teams or assign relevant GSS staff to carry out this function • Contribute to the development of processes, procedures, tracking systems and IT solutions for GSS activities • Assist in the preparation and presentation of services, costs and proposals for new business • Management of GSS portion of project budgets, including input into preparation of utilization reports (projected and actual) and implement measures to ensure accurate billing • Assess workload and staffing needs of group (resource allocation) • Interact with internal and external work groups to evaluate and forecast workload and resource needs • Present at internal and external meetings including client meetings • Ensure appropriate communication on project-related matters with the clinical project team • Assist in the design and maintenance of tools/processes relevant to feasibility assessments and patient recruitment campaigns • Supervision of Investigator Package review and approval prior to drug shipment • Supervision of study set-up with the clients regarding (Pre-study documentation for Investigator Packages) • Supervision of development and review of Investigator Package Plans • Clinical trial supply coordination: o Provide consultation pertaining to clinical supplies: the labeling, tracking, specific national requirements o Ensure triggering of drug shipments to investigational sites o Manage Drug distributor o Supervise development and review of Clinical Trial Supplies Plans • Supervision of Document Review, including Informed Consent Forms, Advertisements, labels and protocols •Thorough knowledge of ICH Guidelines and GCP, the clinical trial process and a basic understanding of regulatory requirements in other countries •Understanding of global drug development and the clinical trial project management process, with emphasis on investigator sites, site activation processes, patient recruitment and retention •An understanding of aspects surrounding Covance business development and financial control (time and cost estimates, bid defense, contracts) •An understanding of relevant Covance procedures, including Standard Operating Procedures •Ability to network, negotiate and liaise face to face and remotely with high level internal and external stakeholders in a professional manner •Demonstrated strong team working and team leadership skills •Ability to manage multiple competing priorities and projects without supervision, including strong communication, planning & organizational skills •Ability to inspire and lead by example and motivate teams to seek solutions and get results •Abilities to review/analyze and report relevant data so as to assist in building evidence-based clinical trial strategies •Abilities to review analyze and report interpret protocols and regulatory documents •Strong computer skills with an ability to understand, access and leverage technology alternatives •A working knowledge of ICH GCP, US FDA regulations, regulations applicable to local office, guidelines, and practices regarding Good Clinical Practices. Preferred: •7 years Clinical Research Project Management experience. •Demonstrated Site Services experience •Demonstrated Regulatory, GMP or QA experience. University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) 9/1/2010 11:32:05 PM http://biospectrumasia.com/JobDetails.asp?jobId=10911