Develop and maintain SOPs for IND management. Most of the candidates make their very creative with relevant information that makes resume making challenging and tricky. Pricing, contracting, and/or managed markets organizational and governance design; and, Therapeutic areas across primary care, specialty, oncology, and generics, Developing pricing and profitability strategy emphasizing an extensive track record of managing large scale projects that involve thinking critically about the business model and processes, and articulating a vision for the future of the business through thought leadership, Identifying and addressing client needs; developing and sustaining deep client relationships using networking, negotiation and persuasion skills to identify and sell potential new service opportunities; preparing and presenting complex written and verbal materials; and defining resource requirements, project workflow, budgets, billing and collection, Leading and Overseeing complex projects related to pricing and profitability, Leveraging industry knowledge and analytical skills, especially as it relates to project management and project facilitation, Leading and/or facilitating teams and developing client proposals, leveraging extensive business development and relationship management knowledge, Interacting with senior leadership in client organizations, Leading teams to generate a vision, establishing direction and motivating members, creating an atmosphere of trust, leveraging diverse views, coaching staff, and encouraging improvement and innovation, Leveraging business transformation skills with a track record of successful change enablement with quantifiable results, Utilizing analytical skills with the ability to translate complex problems into simple and actionable tasks. Uses correct identification as per procedures, Supports and/or participates in mechanic reparation and preventive maintenance, ensuring compliance with manufacturer specifications, Inspects manufacturing tools and utensils, maintaining them in good condition and maintaining related documentation, Performs the accountability of materials, ingredients and components in the different stages of the manufacturing process Completes documentation accordingly, following good documentation practices, cGMPs and SOPs. While writing a resume, you should always prioritize mentioning the skills that have relevance to the profile you are applying for. Rather candidate should present their personality and talents in a professional way. A Guide on CV vs Resume: Differences Explained and When to Use Which. Leads the development of compliance and safety goals for direct reports. Chegg is an e-learning company which provides digital and physical textbook rentals, online tutoring, and other student services. MES) system preferred, Demonstrated ability to communicate positively with personnel at all levels, Demonstrated ability to collaborate with others in cross-functional settings, Proven organizational, analytical and problem solving skills are required to appropriately balance short-term business demands, 3rd Shift Position Sunday through Friday (10:00pm to 6:30am), 3 – 5 years pharmaceutical / FDA regulated production, new product development, or API manufacturing required, 1-2 years production management / supervision experience required, 6+ years pharmaceutical / FDA regulated production, new product development, or API manufacturing preferred, 3+ years production management / supervision experience preferred, Must have the maturity to utilize scientific and technical knowledge to provide unique business solutions, Experience must be in a scientific discipline with expert knowledge of pharmaceutical development, including an understanding of current laboratory techniques, instrumentation, problem solving techniques, process engineering and manufacturing development, and statistics used in experimental work, Must demonstrate knowledge of several allied fields such as chemical engineering, analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs. This includes the development of new market and/or applications, Growing the Business: Define and drive short and mid-term product plans and longer term product roadmaps and end use customer program. Resume for MCA freshers, Sample Resumes and Templates for MCA freshers . Transfers, qualifies or validates methods as needed. Follow up on assigned opportunities through closure, Transfer new accounts and projects to other teams within Project Management as appropriate, Act as the Project Manager for assigned accounts. Pharmacists are people who have formal practices in the pharmaceutical field that are responsible for the safe and effective use of medicine. Ensure quality of international registration documents, Interact with authorities where appropriate. Pharmacy, Manufactures, Wholesalers) to manage current and develop new partnering opportunities, Generate innovative / creative ideas that align to our strategic objectives, Identify and prioritize opportunities for feasibility studies and concepts, evaluating the overall value they can deliver as a basis for prioritization of future product development projects, Accountable for the success of the Drug Benefits offering, Build and influence effective two-way communication with key internal business partners, specifically Business Development, IT, Finance, Legal, Claims/Operations, incorporating their view into the strategy and the product development, Licensed pharmacist (practicing pharmacist is preferable), 6 - 8 years in a variety of marketing, product development functions, Pharmacy Benefits Management, or other relevant experience, Organizes and provides guidance in the business planning process as well as monitoring progress towards individual and district level goals, Identifies opportunities using sales data, insights, and customer needs to effectively, Previous industry management experience (2-3 years), Previous Hospital/LTC experience preferred, Strong leadership, interpersonal skills and communication agility with various stakeholders, Strong business acumen and project management skills, At least 1 year of work experience in a GMP (Good Manufacturing Practice) facility is preferred, At least 1 year work experience in oral solid dosage manufacturing (blending, compression, pan coating, fluid bed or encapsulation manufacturing processes) is preferred, Flexibility to work a non-traditional shift is required, Bachelor’s degree in Chemistry, Biology, Pharmacy, or related 4 year science degree required, Knowledge, practical application, and understanding of analytical chemistry is necessary to perform the functions of this position, Demonstrated capability for communicating ideas, concepts, and work results effectively to colleagues and supervision, Demonstrated ability to be self-motivated as well as to work collaboratively in a team-based environment is required, Must demonstrate initiative and a willingness to learn, Good working knowledge of advanced laboratory instrumentation and personal computer skills are required, Experience in wet analytical methods and instrumentation techniques preferred; HPLC, UV, GC, IR, AA, TOC, and Dissolution preferred, A working knowledge of organic chemistry, statistics, data processing and good manufacturing practices is desirable, A thorough understanding of National Formulary (NF); United States Pharmacopoeia (USP); and European Pharmacopoeia (EP) testing procedures, as well as, US Pharmaceutical Industry Good Manufacturing Practices (GMP’s), quality control methods and procedures preferred, Competencies required: analytical problem solving, alertness, work within established policies and procedures, commitment to task, decisiveness, effective written and interpretive communication skills, and organization and planning skills, At least 1 year of lab experience preferred, Assigned within the lab: bench chemistry or lab experience preferred, Assistant/Associate Quality Control Lab Analyst provides Quality support to the Incoming Material Supplies Inspection processing and laboratory areas, Will perform activities that support and ensure process quality and data integrity with incoming sampling of raw materials and inspection of primary packing components, The Contractor Quality Analyst will become knowledgeable in Federal and other regulatory agency requirements and cGMPs to assure that all areas in compliance, and will train on and gain competency in activities to support incoming sampling in Classified D and C processing areas and component inspection. Completes log books, as required, Responsible for performing assembly and packaging operations and assisting in visual inspection/filling operations, if required, Ensures components, materials and supplies are stocked prior to the start of the assembly and packaging operations, Preparation, review and QC checks of CMC sections of INDs, NDAs, IMPDs and MAAs, Investigation of product complaints and preparation of investigation reports, Preparation and maintenance of Vanda's SOPs for CMC activities, Perform GLP audits of bioanalytical testing laboratories/prepare audit reports, Perform GMP audits of manufacturing, packaging and labeling sites/prepare audit reports, 3 - 5 years of experience in preparation of CMC documents and performing GMP audits, Knowledge ICH/CTD/FDA/EMA guidelines on preparation of CMC documentation, Knowledge of ICH Q7 and 21 CFR Parts, 11, 58, 210 & 211 and EudraLex GMP regulations, Ability to work effectively and efficiently on multiple projects, Actively participates in the identification and implementation of manufacturing procedure improvements intended to optimize existing or new processes and ensure achievement of regulatory and safety requirements. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position, The qualified candidate will have level appropriate relevant experience in pharmaceutical product development, clinical development, engineering, manufacturing, discovery, business leadership or product design. Criteria of strategic importance to the client are often included in the contract as well, and typically define additional commitments required of CH2M HILL to achieve delivery success (e.g. Firms always look for employees who complete their work on time. Some people just go ahead and make a resume that looks at life as if they are craving for a job. Resolve manufacturer customer issues by working internally with appropriate key operational teams, Manages customer relationship with key strategic pharmaceutical and biotech accounts. Fulfill all related tasks and responsibilities related to own discipline. Ensure costs and cost awareness in all assigned projects, networks and/or platforms. There may be variations on the job that they do depending on the … Develops revised methodology where appropriate, Performs qualitative and quantitative analytical tests utilizing approved protocols and test procedures to support the receipt and release of raw materials, intermediates, APIs and drug products and/or to evaluate unknowns, new materials, and/or new formulations in support of development chemists’ efforts (e.g., identification, characterization, degradation studies), Performs qualitative and quantitative analytical tests utilizing approved protocols and test procedures to establish and maintain reference and working standards required for the evaluation of APIs and drug products. Familiarity with industry-standards such as ICH, IMPD, XEVMPD, Experience with the software development lifecycle, specifically in a validated environment, Experience owning a defined portion of a project, and a demonstrated ability to manage issues and risks, with an understanding of appropriate and timely escalation, Experience managing client and vendor relationships. Therefore, think like you are a product and you need to advertise yourself by mentioning all the relevant talent of yours. A brilliant Resume is indispensable along with the guidance of experts, especially if you are a fresher. Search for; Indian Pharma Resources. Income Tax Compliance - Preparation of Corporate and Partnership return workpapers (federal and state) … To get … Demonstrate high ethical and professional standards at all times, Meet the production schedules outlined by team and/or Supervision, Assist with technical troubleshooting and preventive maintenance tasks as needed and trained, Take action to safely reduce equipment setup and changeover times, Initiate and establish equipment operating parameters to maximize production, while meeting all product specifications, Ensure product quality by performing in-process checks, complying with cGMPs, being alert for unacceptable quality of incoming and outgoing materials, initiating quality improvements, and participating on quality improvement projects, Communicate quality and other non-compliance issues to supervision in a timely manner, Complete, maintain, and update production documentation (both electronic and paper) to perform material movements, material take-outs and yield determinations by following SOPs and utilizing systems as required such as Systems/Applications/Products (SAP), Manufacturing Execution Systems (MES), Electronic Batch Records (EBRs), etc, Operate motorized and non-motorized material handling equipment for assigned stocking operations as well as stand up and sit down fork trucks as needed, At least 6 months experience using motorized & non-motorized material handling equipment, At least 6 months experience using automated inventory system is required or equivalent computer systems (i.e., SAP, MES, Microsoft Software, etc. Formulation, manufacturing (including GMP pilot plant), analytical testing and clinical supply functions totaling more than 100 staff, report to this position. Cv Resume Format India Film Resume Template Beautiful Cover Letter … Ficial Resume format India Sidemcicek Official Resume format … We will close our vacancies to new applicants once the requirements have been filled, We are able to offer internships across all GE businesses and as such, our Internship Recruitment Team will provide further information on available industries and locations during the hiring process, Currently studying towards a Lifesciences/Pharmacology related degree – penultimate/final year, Enthusiasm and interest for the functional area applied for, Able to take ownership for projects and work to time limits, Able to roll up your sleeves and get involved in challenging projects, Build a team of colleagues that provides project management and technical support appropriate for coordinating. Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals, Program or project responsibility generally within the function. good knowledge of accounting standards, Familiarity with Sarbanes Oxley and internal controls, 3+ years of pharmaceutical ad agency experience, Experience writing for the insurance / healthcare industry, Bachelor Degree required. Chegg’s online tutoring connect millions of students across the globe with thousands of tutors. Here are some don’ts while writing your resume. Choose a layout that highlights your relevant skills creatively and in an organized manner. Pharmacy Technician. Has the ability to see business needs outside of ones own work area and to drive a cross-functional agenda, Excellent written and oral communication skills. Develops specific short-term and long-term plans and programs, together with supporting budget requests and justification. standardization, transformation, rationalization, linking and matching that leverages data standards, processes and technology management for data, master data, and metadata; and, data security (including data masking and related data protection techniques), Identification and addressing of client needs--developing and sustaining deep client relationships using networking, negotiation and persuasion skills to identify and sell potential new service opportunities; preparing and presenting complex written and verbal materials; and defining resource requirements, project workflow, budgets, billing and collection, Team leadership--generating a vision, establishing direction and motivating members, creating an atmosphere of trust, leveraging diverse views, coaching staff, and encouraging improvement and innovation, Global trends in market access and requirements for launch management, Key market requirements regarding access strategy, pricing and reimbursement, especially in the context of product launch or lifecycle management, Pricing and profitability strategy, price setting, and innovative contracting, Contracting and rebate modelling for the US market, Target product profile development, unmet market needs, clinical end points to support pricing and market access strategy, country launch sequencing, and other pricing and market access factors, Budget impact modeling, including pharmacy and medical claims analyses. How to Write a Resume for Freshers? Get the Sample Resume for freshers and; experienced professionals designed by Naukri experts. Evaluates and applies modern operational excellence tools to reduce process variability and steadily deliver measurable efficiency, productivity or quality gains, Collaborates within department and cross-functionally to meet set objectives. Understands, documents and adjusts Quality Systems to match the project stage (e.g. Is a member of the Small Molecule Development leadership team, Develop, implement, and monitor practices, policies and strategies for the department to support the small molecule portfolio. contribute, comment and influence proposed legislation), Sit on industry committees and work with the industry association as applicable, Continue to position SLF as a recognized leader in drug benefits within the insurance industry, Assist our Business Development team with client acquisition and retention, providing them with material and consultation for client presentations, Work with key Industry Stakeholders (e.g. The manager will also develop and maintain resource planning tools in order to project staffing needs and manage cost for the shift team. Did documentation preparing (complied with GaMP5 and ICH Q9 Quality Risk Management), Knowledge on pharmacy process (familiar with one or two typical process), Understand pharmacy industry control project requirement, Minimum 5 years of pharmaceutical batch project or Pharmacy factory DCS system maintenance experience, Computer science fundamentals (OOPS, Operating System, Data Structure, Office), Knowledge on Microsoft SQL Server 2000 / 2005 / 2008, VB,VC++ preferred, Willing to study & Learn new technologies on demand through websites and implement the same as per the project requirement in Batch project domain, Knowledge on testing methods will be an added advantage, Develop and execute manufacturing work plans/schedules for self and team, using customer milestones and Division/site performance standards and metrics, Independently authors and approves technical documents, such as protocols, technical reports, test methods and operating procedures, Review technical documents for accuracy, thoroughness and regulatory compliance, Trains, coaches or mentors others on technical, personal development or business issues, Supervises technical staff, including work assignments and performance and development management, Responsible as project director on multiple projects, with responsibility for project outcome and customer interaction, including developing customer relationship to grow the business, Identifies and independently drives department level improvements, Identify and recommend business strategies for multiple customers across multiple company sites, Manages professional employees and/or supervisors, Is accountable for the performance and results of a team within own discipline, Adapts departmental plans and priorities to address resource and operational challenges, Decisions are guided by policies, procedures and business plan; receives guidance from manager, Provides technical guidance to employees, colleagues and/or customers, Uses leading-edge knowledge of principles, concepts and practices and/or techniques to lead complex projects within a department/ group/team that may involve related departments/groups/ teams, Applies technical, functional, business and/or industry knowledge to design experiments/projects, Provide scientific consultation to the department/ discipline/group, Actively contributes to the strategic direction of the department/ group by recommending expansion or curtailment of investigations on the basis of experimental results or scientific information, Maintain high quality documentation in accordance with applicable regulatory guidance and Site SOPs, Experienced in most aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones, Has substantial breadth/depth of technical acumen in multiple techniques with significant expertise in one or more techniques and can understand their application in context of pharmaceutical services offerings, Capable of rapid learning of multiple unfamiliar principles or techniques with minimum training, Is able to lead difficult discussions with customers and drive the conversation to an acceptable resolution, Recognized by internal and external customers and direct reports as a subject matter expert with high personal credibility, Can assess training needs and formulate development plans for direct reports, Works directly with Business Development to win new business (conference calls, new customer meetings, some travel), Ability to interpret, provide and manage a variety of instructions furnished in written, oral, diagram, or schedule form across multiple work groups and departments, Understands the details of regulatory CMC filing package and the analytical and formulation documentation required therein. 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