Global outsourcing continues to play a major role in medical device development and manufacturing. In Operational Strategy Globalization in Life Sciences Companies, A Life Sciences Industry Vision for 2010, a report by PRTM, 2-year growth numbers as high as 85% are predicted for global outsourcing of product development in the industry, while nearly half of companies surveyed will have globalized manufacturing by 2010. And yet, the same report claims that many companies are having difficulty realizing savings in management costs.

In other words, it seems that when most companies enter global outsourcing initiatives to reduce cost, they underestimate the management complexity to bring such an initiative to a successful conclusion. Why?

In my experience, global outsourcing projects are initiated and driven by a goal of cost reduction and/or “bandwidth” considerations, but fall short in adequately planning for new dimensions that global outsourcing brings about.

More often than not, an outsourcing project is started with an RFQ (Request For Quotation) sent to prospective contract manufacturers (and/or design firms). The RFQ process typically includes technical specifications, and is usually focused on cost and a business/financial evaluation of the company.

The responses to the RFQ then narrow down the list of potential suppliers, and a more detailed due diligence is performed, typically focused on quality systems, supply chain management, technical capabilities etc.

Then, once the final supplier is chosen and the project is kicked off the “rubber meets the road” and  issues start to arise. Managers start to realize that no matter how detailed a technical specification is written, and no matter how well up-front due diligence evaluated the new business partner from a technical perspective, communication breakdowns occur frequently. Global management complexity increases exponentially, spanning timezones, cultures and language barriers.

Most companies figured out in the 80’s and 90’s that an internal “silo” mentality is detrimental to quality, innovation and productivity. But as global outsourcing replaces large parts if not complete functions such as manufacturing and product development, companies tend to set themselves up for management of an external “silo” located in a different part of the world — unless they structure the outsourcing activity appropriately.

So what can companies do to manage this added complexity?

• Step 1: Dimensionalize the outsourcing relationship up front. What are all the dimensions that are important to your company when selecting an outsourcing partner? Don’t limit this list to technical, process or financial issues. Include all fundamental dimensions that are vital in a good corporate relationship, such as corporate culture and values, corporate strategic objectives, leadership, communication, etc.
• Step 2: Prioritize these dimensions with input of senior management. Separate the “vital few” from the “trivial many”: what are the dimensions that will make or break this relationship?
• Step 3: Evaluate your prospective outsourcing partner based on all of those critical dimensions, and do so from the start. Include a pre- RFQ phase to evaluate critical dimensions that are not technical or finance related and eliminate companies that are not adequately aligned. Have clear up-front discussions with potential partners about this process.
• Step 4: Implement. Include all of these critical dimensions in a clear supply agreement. This agreement now will not just cover technical and financial considerations, but also critical elements of strategy, leadership, communication/escalation mechanisms etc. Note that to avoid an “outsourced silo”, contact points throughout both organizations must be established at multiple levels for good communication.

Outsourcing can and will continue to play a major role for many medical device companies in the future, as companies find ways to focus on their unique competitive advantage. I have seen many examples of clients who realized significant cost savings in overall successful outsourcing projects. But only companies who find ways to effectively address the management complexity associated with global outsourcing will be successful.

For more information or to schedule a no-charge strategy session by telephone, contact Guy Sohie at gsohie@valeollc.com

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Tel Aviv, 19 y 20 de enero de 2010

El Instituto Español de Comercio Exterior (ICEX), en colaboración con la Oficina Económica y Comercial de la Embajada de España en Tel Aviv, organiza un Encuentro Empresarial España-Israel, que tendrá lugar los días 19 y 20 de enero de 2010 en la ciudad de Tel Aviv.

El objetivo principal de este Encuentro Empresarial es facilitar la identificación de oportunidades de inversión y cooperación empresarial, así como de potenciales socios en Israel. En este sentido, durante la celebración del mismo, usted podrá tener un contacto directo con empresarios israelíes interesados en establecer alianzas estratégicas con empresas españolas, y conocer de primera mano a la Administración local y los planes de inversión de Israel en infraestructuras para los  próximos años.

Este Encuentro Empresarial persigue reforzar la imagen exterior que desea ofrecer el ICEX de una España industrial, poseedora de un entramado empresarial cada vez más internacionalizado.

La participación en este Encuentro Empresarial permite, por un lado, consolidar la presencia de aquellas empresas establecidas en este mercado con el respaldo de las instituciones del Estado, y, por otro, impulsar las actividades de aquellas empresas participantes que inician su trayectoria a través de este programa.

Los sectores y subsectores que han sido elegidos como prioritarios en este Encuentro Empresarial son los siguientes: Telecomunicaciones, Software, Tecnologías limpias, Medioambiente, Equipamiento Médico, Energía solar, Biotecnología, Automoción eléctrica, Financiero (capital riesgo), Infraestructuras y obras públicas, Ferroviario y Tratamiento de Aguas.

Si desea participar en el Encuentro Empresarial España-Israel deberá rellenar el formulario adjunto de forma detallada y enviarlo, a la máxima brevedad posible, a la siguiente dirección:

Dpto. de Cooperación Empresarial – ICEX

Paseo de la Castellana, 16

28046 Madrid

Tel.: 91 349 6483

Fax: 91 575 9618

Cooperacion.Empresarial@icex.es

Formulario Inscripcion Israel

Respiratory therapist needed for a Asia Pacific clinical support role with a pharmaceutical/medical devices MNC. For details, please email headhunter@asia.com.

Pharmaceutical company (US-based) seeking candidates experienced in clinical sales and clinical support functions for the role of Clinical Support Manager, Asia Pacific. Position to be based in Singapore. Preference given to candidates with prior experience in similar capacity with pharmaceutical or medical devices industry, or current clinical staff.

For more details, email headhunter@asia.com

Requirements play a pivotal role in software development.  Getting into a common understanding of various types of requirements is the biggest challenge.  Business and customer expectations are getting complex.  Those days are over where we can understand and write down the requirements on a simple word document.  In a recent industry study, it shows, poor requirements costs as much as 60% of the total time and budget!

Visual representation is much better than written down text.  This helps to reduce the silos of language barrier.  Brings a common understanding to the context too.  Whether you follow waterfall, iterative or agile methodology, requirements and it’s clarity plays a significant role in the success of a project.  Of course you may be colleting the requirements in various names:  Use cases, stories, functional and non-functional etc. but fact remains the same.

When you would like to capture a business process as a process diagram, or you would like to capture a user interface storyboard to highlight a sequence, or would like to use a rich text scenario, all these can be captured in IBM Rational Requirements Composer.  The major advantage is that you can store everything in a single repository for common access among various stakeholders.

Once we have properly defined the requirements, then we need to classify them, prioritize them and set up a relationship & traceability among them to assess a change impact, for this you need a requirement management tool.  If you combine one of the requirement management tools like IBM Rational RequisitePro or IBM Rational DOORS, you are increasing the possibility of success.  Now, how do you choose among the two requirement management tools?  It is simple, depending on your project. If your projects are in the IT areas like, banking, insurance, retail etc, you can choose, IBM Rational RequisitePro.  Where as, if your projects are in the areas like, avionics, defense, medical systems, in general systems side, IBM Rational DOORS will be the right candidate.

In short, the time has come to look deeper into the requirements elicitation, definition, description, stakeholder concurrence and proper requirement management.  Let’s get into more serious tools than just documents, to have more predictable project success.

Asia Pacific Ophthalmic Devices Investment Opportunities, Analysis and Forecasts to 2015 report ( http://www.bharatbook.com/detail.asp?id=126942&rt=Asia-Pacific-Ophthalmic-Devices-Investment-Opportunities-Analysis-and-Forecasts-to-2015.html ) is an essential source for in-depth information and data relating to Asia Pacific ophthalmic devices market. It also offers detailed and comprehensive coverage of market revenue, volume, distribution and company share information; and the latest news, financial deals and pipeline products information of each of the key sub-segments of the ophthalmic devices market in Asia Pacific

Scope

- The report provides information on the Asia Pacific ophthalmic devices market, broken down into detailed categories and segments including Ophthalmic Devices, Cataract Surgery, Vision Care, and Refractive Surgery.
- Total revenues, products sold and end users.
- Market shares of all the key competitors including Bausch & Lomb Incorporated, Alcon, Inc., Johnson & Johnson Vision Care, Inc., and Essilor International, amongst others.
- Key pipeline products that are set to shape the market, broken down by sector.
- Information on the top medical equipment companies in the sector in the country covering business description, strategic analysis, and financial information.
- Healthcare structure, regulatory environment, approval process, pricing trends and reimbursement.
- Product and brand updates, strategy changes, R&D projects, corporate expansions and contractions and regulatory changes.
- Key mergers and acquisitions, partnerships, private equity investments and IPOs.
- Customer, hospitals and physicians data.

Reasons to buy

- Gain a strong understanding of the ophthalmic devices market in Asia Pacific.
- Evaluate and compare the attractiveness of the market in the region.
- Identify growth segments and opportunities in each industry sector within the region.
- Evaluate the pipeline of key products that will change the sector, and identify threats and opportunities before the products are launched in the region.
- Analyze the competitiveness of the market in the region and identify hotspots.
- Develop strategies based on the latest product, brand, expansion and research and development news in the region.
- Do deals with an understanding of how competitors are financed, and the mergers and partnerships that have shaped the market in the region.
- Identify and analyze the strengths and weaknesses of the industry incumbents in the region.

To know more and to buy a copy of your report feel free to visit : http://www.bharatbook.com/detail.asp?id=126942&rt=Asia-Pacific-Ophthalmic-Devices-Investment-Opportunities-Analysis-and-Forecasts-to-2015.html

Or

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Landing Zone is refocusing with the goal of providing the leading resource for international companies seeking to develop the US market. More coming soon.

Job Position: Research Associate II/Associate Scientist I
Job Location: Gaithersburg, MD US
Job Status: Full-Time

Position Details
Title: Research Associate II/Associate Scientist I Location: MD, Gaithersburg – Corporate Headquarters Req: 02108 Position Summary: Major Duties and Responsibilities (including supervising others): The Associate Scientist will develop, implement, and perform assays for drug development in oncology. Laboratory activities will include routine cell culture, collection and processing of biological materials, and in vitro assays.

For complete job description and how to apply go to the Beaker.com

About beaker.com: Beaker is the premier recruitment solutions in the life sciences industry connecting Life Sciences Employers and Candidates.

Job Position: Technical Delivery Manager
Job Location: Gaithersburg, MD US
Job Status: Full-Time

Position Details
Title: Technical Delivery Manager Location: MD, Gaithersburg – Corporate Headquarters Req: 02109 Job Description Position will work in IT addressing the business technology needs within the area of Medical and Regulatory Affairs. Position will be responsible for understanding business problems and working with relationship managers, business analysts and technical teams to develop technology solutions in support of business needs. In addition, position will be responsible for overseeing technology solutions; implementing system-based solutions; and managing vendor partners and internal resources in the delivery and support of technology to satisfy MedImmune’s business capability needs. Position will be responsible for technical oversight and management of projects. Position will own technical requirements definition based on functional requirements and taking the solution blueprint, in conjunction with the user requirements, and turning it into a detailed design or configuration. Position will assess the scope of new project efforts by estimating the work involved, resources required and time line for technical delivery efforts. Position owns solution prototyping and change management, blueprinting (fit/gap) and quality assurance; manages the development and delivery activities within SDD in support of project and non-project activities. Has direct responsibility for the overall success of the assigned project and deliverables, either through direct participation or oversight. Projects may include new applications and modules, major or minor enhancements to existing applications or modules and product upgrades. Position will work with business owners, relationship managers and IT to manage the development to production and the production to operations activities following established methodology. Activities include internal code reviews, testing, supporting user acceptance testing, developing a support approach, application training, disaster recovery plans, application process maps and others as defined by the IT PMO. Position will keep customers (to include business owners, relationship managers, and internal IT management) apprised of progress, issues, and risks in a timely manner. Position will practice risk management strategies to ensure that project commitments are realistic and met. Position will participate in the establishment and implementation of SDLC methodologies, ITIL processes and IT PMO processes and ensure that IT projects adhere to those standards and meet customer expectations International travel may be required.

For complete job description and how to apply go to the Beaker.com

About beaker.com: Beaker is the premier recruitment solutions in the life sciences industry connecting Life Sciences Employers and Candidates

Job Position: Senior Director, R&D
Job Location: Gaithersburg, MD US
Job Status: Full-Time

Position Details
Title: Senior Director, R&D Location: MD, Gaithersburg – Corporate Headquarters Req: 02112 Position Summary: This position will provide technical, operational, and strategic leadership for the Biological Analysis group within the Analytical Biochemistry department. Technical areas include: bioassay, immunoassay, PCR, and biosensor method development, in-process, and release testing. Major Duties and Responsibilities (including supervising others): – Establish strategy, direction and objectives for a rapidly growing group of 40 plus that are consistent with overall function, R&D, and MedImmune goals and objectives – Develop strategic plans for clinical and commercial products to support pre-clinical development, clinical product development, product life-cycle management and associated regulatory submissions. – Provide technical advice, where needed, to assure the highest quality of data is developed and presented. – Serve as spokesperson for Development in verbal and written communications with regulatory agencies, R&D product development teams for all therapeutic areas, and other internal and external groups of interest. – Oversee the creation and review of presentations for outside scientific meetings and conferences to assure they meet corporate standards. – Proactively, participate in diligence activities with Business Development and author summary of findings. – Oversee the creation and review of documents such as: method development reports, SOPs, validation protocols/reports, CMC regulatory filings (IND, IMPD, BLA, etc.), and scientific journal publications. – Develop new cutting-edge technologies for improving efficiency of in-process testing and product characterization. – Actively maintain and evolve the department’s strategic direction to meet organizational needs. – Maintain effective communications with Process Development groups as well as Regulatory Affairs, Clinical Development, Quality Control, Quality Assurance and Research. – Assure all laboratory documentation and other regulatory compliance systems are maintained according to corporate standards. – Ensure effective day to day operations of the organization including talent development, performance management, budgeting, etc.

For complete job description and how to apply go to the Beaker.com
About beaker.com: Beaker is the premier recruitment solutions in the life sciences industry connecting Life Sciences Employers and Candidates.

Job Position: Clinical Services Associate I
Job Location: Gaithersburg, MD US
Job Status: Full-Time

Position Details
Title: Clinical Services Associate I Location: MD, Gaithersburg – Corporate Headquarters Req: 02113 Position Summary: The Central Services Associate I supports the Clinical Study Teams with a special emphasis on study start up activities and CTMS support. Major Duties and Responsibilities: – Contributes to the clinical study team through all study phases from study start-up, maintenance through study closure. – Set up , populate and accurately maintain key study information in the appropriate system (e.g. CTMS) Major tasks include: ? Input trial descriptive information (indication, phase, design, etc) ? Setup trial configuration for enrollment tracking and monitoring (setup countries and sites, study visit design, monitoring setup, documents template setup, checklist setup, etc) ? Maintain trial team list, site contact and investigator information ? Track regulatory documents and study documents – Coordinate with the Resource Performance Management group, request, distribute and track confidentiality agreements for sites – Distribute, retrieve and track feasibility and capability questionnaires to sites as directed by study teams – Distribute, retrieve and track site regulatory documents as requested by study teams – Partner with clinical study sites to track scientific review committee meetings, IRB meetings, Ethic Review committees to drive timely procurement of study start up documents. – Complete QC on regulatory documents – Prepare completed regulatory packages for CPM or designee approval – Process completed signed regulatory packets to regulatory for final approval – Transmit appropriate documents to the Trial Master File (TMF) – Work with Clinical Research Associates (CRAs) or site monitors to ensure collection of outstanding documents during site visits. – Assist with preparation for internal or external meetings , including Investigator Meetings, training meetings and or Vendor Meetings – Perform data entry and check quality , consistency and integration of clinical sites data in the applicable systems As directed by the CPM or Lead CRA – Initiate and track drug shipment requests – Assist in the preparation and assembly of Study Specific Investigator site binders.

For complete job description and how to apply go to the Beaker.com

About beaker.com: Beaker is the premier recruitment solutions in the life sciences industry connecting Life Sciences Employers and Candidates.

Job Position: Site Microbiologist
Job Location: Philadelphia PA, 19020
Job Status: Full-Time

Position Details

Title: Site Microbiologist Location: Philadelphia PA, 19020 Req: 01189 Position Summary: Responsible for leading the implementation and maintenance of microbiological quality control systems and activities, equipment and procedures, support of production and facility activities, staff development and project management. Ensures assays are validated to meet cGMP requirements, and provides QC testing services to internal clients, in support of process development, manufacturing, and stability evaluation. Responsible for the training programs of all site staff in microbiological techniques used for aseptic processing. Responsible for authoring the trending reports of Environmental monitoring data for the manufacturing area and utilities. Has responsibility for the implementation of the Corporate Microbiology policies at each manufacturing site. Has responsibility for authoring the Environmental Monitoring trending reports.
For complete job description and how to apply go to the Beaker.com
About beaker.com: Beaker is the premier recruitment solutions in the life sciences industry connecting Life Sciences Employers and Candidates.

Job Position: Project Manager
Job Location: Gaithersburg, MD US
Job Status: Full-Time

Position Details
Title: Project Manager Location: MD, Gaithersburg – Corporate Headquarters Req: 02114 Position Summary: The Project Manager provides cross-functional operational management to the Product Development Team (PDT), including facilitating issue identification and resolution, problem-solving, contingency planning, and decision-making. This role must be familiar with system scope and project objectives, as well as the role and function of each team member, to effectively coordinate the activities of the team and manage project information and communications to all stakeholders and senior management. Major Duties and Responsibilities: Operations Management and Leadership Drives cross-functional, operational integration for the PDT, including coordinating cross-functional activities and communications involving team members and external partners with minimal supervision. Coordinates the creation and maintenance of the integrated Product Development Plan and timeline. Ensures linkage between strategy and operational activities. Identifies issues and facilitates problem-solving, contingency planning, and decision-making. Informs key stakeholders of status, issues, problems, and proposed solutions as appropriate. Assumes full responsibility for managing specific aspects of the project as designated by team leadership. Partners with team leader to foster effective team dynamics. Provides performance feedback to team and cross-functional line management on PDT members. Project Timeline, Resource, and Cost Management Collaborates with cross-functional team members to support the PDT¡¦s strategy and execution of deliverables. Works with the PDT to develop, maintain, and align an accurate, integrated project timeline, resource plan, and budget. Understands critical path activities, anticipates risks, and creates contingency plans in collaboration with project teams. Generates analyses of timeline, resource, and budget information that facilitates scenario planning, contingency planning, risk assessment and management, problem-solving, and decision-making. Monitors and manages team performance metrics relative to agreed upon project plan. Coordinates interactions with corporate governance bodies to ensure programs have adequate budget and resources to support approved scope. Identifies deviations from PDC-approved project plans and timelines and informs the PDT as to their nature and extent. Negotiates with team members to establish new timelines aligned with corporate goals. Provides key data to portfolio management to update project status and impact on therapy area and overall portfolio.

For complete job description and how to apply go to the Beaker.com
About beaker.com: Beaker is the premier recruitment solutions in the life sciences industry connecting Life Sciences Employers and Candidates.

Job Position: Associate Director, Human Resources
Job Location: Gaithersburg, MD US
Job Status: Full-Time

Position Details
Associate Director, Human Resources: â?¢ Leader/Catalyst: Continually assesses internal and external environment, drives organizational alignment initiatives, and leads transformation efforts. â?¢ Significant contributor to Business / Site Leadership group activities which extend beyond HR areas of accountability. â?¢ Develops longer term and annual HR Strategic Plan in conjunction with client business group and HR Leadership, including staffing, and calendar of events for HR program rollouts â?¢ Drives delivery of human resources programs into client group, including talent acquisition, staffing and selection, employment processing, compensation, training and development, talent management and succession planning, employee relations, all relevant legislative requirements compliance, and retention. â?¢ Develops staffing plan in conjunction with client group, assists in the selection of qualified candidates, and ensures that compensation and incentives are administered equitably. â?¢ Develops human resources solutions by collecting and analyzing information; recommending courses of action, and facilitating change where needed â?¢ Helps to drive organizational effectiveness through Performance Management processes; improves manager and employee performance by identifying problems; evaluating, and implementing recommended solutions; coaching and counseling managers and employees â?¢ Manages client expectations by exercising good communication and project management skills â?¢ Clear recognition as the HR expert, and leader of the HR team based upon proven credibility. â?¢ Consults with client group on organizational structures, that will support and enable Talent management â?¢ Enhances HR department and value proposition by accepting ownership for accomplishing new and different requests; exploring opportunities to add value, and ultimately delivering results.

For complete job description and how to apply go to the Beaker.com

About beaker.com: Beaker is the premier recruitment solutions in the life sciences industry connecting Life Sciences Employers and Candidates.