Social Media RSS Feed https://medfrogs.com/rss en Senior Manager, Peripheral Interventions, Reg Affairs Job https://medfrogs.com/job/senior-manager-peripheral-interventions-reg-affairs-job-1411637 <p>Share this Job</p> <p><strong>Date: </strong>Oct 18, 2019</p> <p><strong>Company: </strong>Boston Scientific</p> <p>Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth</p> <p>At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.</p> <p> </p> <p>Our regulatory team is focused on delivering world class performance by working strategically with our cross-functional partners to maintain and bring new products on the market that meet global regulatory requirements.  We partner with regulatory agencies to gain support on innovative and creative regulatory pathways to accelerate product approvals.  We support the Interventional Oncology franchise (IO) within the Peripheral Vascular Division providing cancer and non-cancer treatment options using minimally invasive procedures under image guidance. We help improve and save people’s lives through innovative medical devices and solutions.</p> <p> </p> <p>The Peripheral Vascular Division is a growing division within Boston Scientific with strong leadership and future goals to provide category leadership within the arterial, venous and interventional oncology space.  We promote a collaborative learning environment where ideas, technical expertise, knowledge and experiences are shared to facilitate high performance in us all.  We value quality & integrity, innovation, strategic thinking, and collaboration.  This is a great opportunity to gain franchise leadership exposure, manage the core IO portfolio of existing and new product development, and cultivate a high performing team.  We are looking for someone with global regulatory experience in the US, EU, Japan, and China who demonstrates high regulatory strategy competencies and partners with regulatory agencies.  We want someone who reinforces our core values and is focused on people development.  </p> <p> </p> <p><strong>Purpose: </strong></p> <p>In this role, you will be responsible for product lines, technology, managerial, leadership, and people development activities.</p> <p> </p> <ul> <li>Provide development opportunities for employees</li> <li>Responsible for diverse product lines within the Interventional Oncology franchise including embolization microspheres, microcatheters, guidewires, ablation devices, embolization coils, drainage catheters / stents, etc</li> <li>Manage the transition of MDR compliance for Interventional Oncology medical devices</li> <li>Assists in establishing project priorities, allocating resources and workload</li> <li>Provides technical guidance to the team during the course of submission preparation and interaction with regulatory bodies</li> <li>Reviews and edits submissions prepared by team members</li> <li>Represents Regulatory Affairs at management updates</li> <li>Develops and overseas innovative regulatory strategies for new and modified products</li> <li>Assists with developing and implementing departmental policy and procedure.</li> <li>Provides Regulatory Affairs training/mentoring to employees</li> <li>Assists with developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review</li> <li>Oversees preparation and submission of global regulatory applications as appropriate as well as internal regulatory file documentation.</li> <li>Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support.  Ensure employees are trained to do their work and their training is documented.</li> </ul> <p><strong> </strong></p> <p> </p> <ul> <li>3+ years experience in a people management role</li> <li>Bachelor’s degree preferably in a scientific, technical discipline or project management, Professional certification(s) preferred</li> <li>Demonstrated success in management of regulatory submissions activities including FDA and Notified Body experience</li> <li>Demonstrated success as RA lead on large cross-functional development teams</li> <li>Excellent worldwide regulatory strategic planning skills</li> <li>Submission experience for drug/device combination products preferred (FDA, PMDA, CFDA, ANVISA, Health Canada, TGA, etc.)</li> <li>Experience supporting manufacturing/operations/acquisition driven projects and achieving change approvals globally per business expectations</li> <li>Strong understanding of product development process and ability to effectively partner cross-functionally to develop and influence sound product strategies</li> <li>Strong technical knowledge of medical products</li> <li>Strong technical understanding of relevant procedures, practices, and associated medical terminology</li> <li>Thorough knowledge of product development process and design control</li> <li>Excellent research and analytical skills</li> <li>Excellent people development skills</li> <li>Excellent written and oral communication, technical writing and editing skills</li> <li>Strong leadership, interpersonal and influencing skills</li> <li>Ability to collaborate and build rapport with cross-functional partners, teams, and external regulatory agencies</li> </ul> <p> </p> <p>About us</p> <p>As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.</p> <p> </p> <p>Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran</p> <p> </p> Mon, 10/21/2019 - 14:53 1411637 1411637 Global Study Associate https://medfrogs.com/job/global-study-associate-1411679 <p><b>About AstraZeneca:</b></p> <p>At AstraZeneca, we are united by a common purpose – to push the boundaries of science to deliver life-changing medicines. This purpose underpins everything we do; our work helps to make hearts healthier, to help people breathe easier, and to help more people survive cancer. Every single day, we make a difference by delivering potentially life-changing medicines to millions of people worldwide and by leading breakthrough science that promises to transform the treatment of disease.</p> <p>Our purpose is ambitious and so is our approach. Becoming a more agile and creative company means building a dynamic, inspiring culture where we celebrate entrepreneurial thinking and act with a sense of urgency. We are courageous, taking smart risks and learning from both success and failure. We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of a great place to work; an environment that energizes and empowers each of us to achieve our goal to develop and deliver life-changing medicines.</p> <p><b>Position Title: Global Study Associate</b></p> <p>Position Type: Full-time, Contract</p> <p><b>Location: Mississauga, Ontario</b></p> <p>You are a member of extended global study team supporting delivery of clinical studies to time, cost and quality, from Clinical Study Protocol (CSP) development through to study archiving. The GSA supports Global Study Leader (GSL) and Global Study Associate Managers (GSAM) in delegated aspects of clinical study.</p> <p><b>Responsibilities:</b></p> <ul> <li>You will support Global Study Leaders (GSL) and Global Study Associate Managers (GSAMs) by completing delegated study work</li> <li>You initiate the set-up, maintain and close the electronic Trial Master File (eTMF) to ensure compliance to International Conference of Harmonization Guidelines for Good Clinical Practice (ICH/GCP) and AZ SOPs</li> <li>You will partner with internal functions and external vendors in collection of regulatory and other essential documents</li> <li>You will initiate and maintain production of study documents, ensuring template and version compliance per study specific requirements</li> <li>You will set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. IMPACT, SharePoint, BOX if used, MS teams and study team shared mailbox) and support team members in the usage of these tools</li> <li>You will contribute to the application, coordination, supply and tracking of study materials and equipment</li> <li>You will lead administrative tasks and logistic support throughout the conduct of the study, audits and regulatory inspections, according to company policies and SOPs</li> <li>You will oversee and contribute to the preparation of internal and external meetings e.g. study team meetings, committee meetings, monitor meetings, Investigator meetings and virtual meetings. You will liaise with internal and external participants and/or vendors</li> <li>You will build and prepare presentation material for meetings, newsletters and web-sites</li> <li>You will have the opportunity to provide input into non-drug project work including training activities, and development of procedures as needed</li> </ul> <p><b>Minimum Requirements:</b></p> <ul> <li>University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research preferred;</li> <li>Meaningful clinical experience at administrative level supporting the delivery of clinical trials</li> <li>Validated organizational and analytical skills</li> <li>Previous administrative training/experience</li> <li>Computer proficiency in day-to-day tasks</li> <li>Develop working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with clear comprehension of the ICH/GCP guidelines</li> <li>Excellent verbal and written communication in English</li> <li>Demonstrate ability to work independently, as well as in a team environment</li> <li>Ability to prepare presentation materials</li> <li>Demonstrate integrity and mutual respect</li> <li>Desire and capability to train others on study administration procedures</li> <li>Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities</li> </ul> <p><b>Next steps – Apply today</b></p> <p>To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager will know that you feel well qualified for this position. Do you know someone who would be an outstanding fit? Please share this posting with them.</p> <p>AstraZeneca is an equal opportunity employer. AstraZeneca will consider all applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.</p> <p><b>Great People want to Work </b>with us, find out why:</p> <ul> <li>GTAA Top Employer Award for 5 years: https://content.eluta.ca/top-employer-astrazeneca-canada</li> <li>Best Workplace Culture Award at the 2018 Canadian HR Awards: https://www.linkedin.com/pulse/thriving-best-workplace-culture-gena-restivo/</li> <li>Total Rewards for employees: https://www.astrazeneca.ca/en/working-at-az-canada/Total-Rewards.html</li> </ul> <p>AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.</p> <h2>We’ll keep you up to date</h2> Mon, 10/21/2019 - 14:51 1411679 1411679 Software Development Manager, Clinical Chemistry & Immunoassay - Nationwide https://medfrogs.com/job/software-development-manager-clinical-chemistry-immunoassay-nationwide-1406057 <ul> <li>Connect with us:</li> </ul> <p><strong>Date Posted:</strong> 9/18/2019</p> <p><strong>DIAGNOSTICS: IMPROVE PATIENT CARE, INCREASE QUALITY AND LOWER COSTS</strong>The healthcare industry is changing, and new challenges require new thinking. That's why we don't stop at developing quality clinical diagnostic instruments and assays that enhance your laboratory or network of laboratories. By working with Beckman Coulter, you gain access to a suite of innovations in products, services and business processes that enhance clinical effectiveness and operational productivity.</p> <h2>Job Description</h2> <p><b>About Us</b>Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see.If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at www.beckmancoulter.com.Beckman Coulter is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.</p> <p>Description<br />  </p> <p>The position of Software Development Manager, Clinical Chemistry & Immunoassay (Chem. IA) R&D, India Development Center (IDC) reports to the Senior Manager, Chem. IA R&D with the primary responsibility to lead and manage group of engineers working on development of Chemistry and immunoassay products. The incumbent will provide direct and ongoing leadership for multiple scrum teams comprising of scrum masters, technical and quality leads and software and quality engineers. The Software Development Manager will have full accountability for the on-time project delivery from both business and technical perspectives. The role will require active coordination with multiple partners at other Beckman R&D centers and effective management of multiple cross-program dependencies.  </p> <p><strong>Key Accountabilities  </strong></p> <p>• Manages deliverables and schedules for multiple ongoing projects and programs, ensuring that resources are appropriately allocated, and that goals, objectives and timelines are met in accordance with program and organizational roadmaps. </p> <p>• Engages with program managers, partners at other R&D sites, technical leaders and executives to communicate projects status and escalate issues. </p> <p>• Proactively identifies opportunities for process improvement and efficiency. </p> <p>• Provides overall people-care management for direct reports, including, hiring, setting and monitoring of annual performance plans, coaching, and career development; drives and fosters performance standards, expectations, and practices to support ongoing team members and process development.  </p> <p>• Enables technology and process innovation in team </p> <p>• Actively keeps abreast of emerging trends and technology changes  </p> <p>• Collaborates with a global ecosystem of peers and partners in meeting objectives  </p> <p>• Actively involves and participates in IDC local initiatives  </p> <p>• Ensure various sub project teams are staffed with qualified resources  </p> <p>• Accountable to Chem. IA business unit for the success of Chem. IA projects at IDC  </p> <p>• Responsible for achievement of quality, process adherence and on time delivery goals for the projects  </p> <p>• Identify and drive countermeasures in instances when project is overdue or exceeding budget  </p> <p>• Establish and monitor use of tools for project tracking and management  </p> <p>• Ensure compliance to Chem. IA, IDC, Beckman Coulter, and Danaher policies and procedures  </p> <p><strong>Qualifications </strong></p> <p>• Bachelor’s degree in Computer Science Engineering or a related field with 12 plus years of relevant experience or a Master’s degree with 10 years of relevant experience.  </p> <p>• Work experience should include people management experience and 4 years in program / project management leading multi-disciplined projects. </p> <p>• FDA regulated environment experience is strongly recommended.  </p> <p>• Extensive experience managing agile scrum teams and working with distributed scrum teams. </p> <p>• 8+ years of software development experience in technologies such as C++ / C# .Net or software quality engineering experience with knowledge of test automation. Preferred: Experience developing desktop applications using C# .Net and WPF. </p> <p>• Experience working in Medical Device Engineering or Instrumentation & Control Engineering is preferred. </p> <p>• Fast learner able to quickly become adept at using the Danaher Business System tool set.  </p> <p>• Demonstrated leadership skills with the ability to manage team by influence in a matrix organization.  </p> <p>• Demonstrated success delivering products in a global R&D environment. </p> <p>• Readily accepts responsibility and accountability for project success and key decisions.  </p> <p><strong>Additional Considerations  </strong></p> <p>The ideal candidate for this position demonstrates leadership that is earned and is not attained via position power.  This true leader must be capable of motivating teams to achieve results that they themselves did not realize they could achieve.  The ability to drive change in culture and behaviors is a key attribute of the successful candidate.  In order to succeed in this aspect, the leader must have superior intellect and must demonstrate outstanding work ethic, be capable of understanding and articulating complex scientific, interpersonal, regulatory, and business issues, thus leading and motivating by example, teaching and coaching.   </p> <p> </p> <p><strong>Diversity & Inclusion</strong><br /> At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. Danaher Corporation OverviewDanaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.</p> <h2> </h2> <h2> </h2> <h2> </h2> Mon, 10/21/2019 - 14:34 1406057 1406057 Marketing Manager – Travel and Endemic Vaccines https://medfrogs.com/job/marketing-manager-travel-and-endemic-vaccines-1406538 <p><b>Functional Reporting to: </b>(when applicable)</p> <p><b>NA</b></p> <ul> <li>Provide strategic leadership for portfolio consisting of vaccine for Travel & Endemic franchise and Meningitis</li> <li>Develop & implement cross functional brand plans based on the market insights to meet organisation objective with a measurable impact</li> </ul> <p><b>Collaboration</b></p> <ul> <li><b>External</b></li> <li>Alignment with various stakeholders for the brand objectives across functions and geographies</li> <li>Market entry & expansion – Identify & develop new segments, indications and expand the current vaccine uptake, launch brands and key brand initiatives</li> <li>Drive consumer & HCP awareness, education, activation & advocacy in collaboration with relevant stakeholders to increase vaccine entry & uptake</li> <li>To understand and comply with the organization values & Code of Ethics for the function</li> </ul> <p><b>Scope of the Role (Team, Geographical, Material) </b></p> <ul> <li>The role will be based out of the Corporate Office, Mumbai & may involve travel.</li> <li>Single contributor role in the beginning and may become a people manager role in 1-2 years</li> </ul> <p><b>Duties & Responsibilities</b></p> <p><b>People</b></p> <ul> <li><b>Stakeholder Management &</b><b>Transversal Collaboration with brand teams </b>- Ensure alignment of all the key stakeholders for successful brand plan development and alignment. Ensure smooth working relationships and thorough buy-in of brand plan & tactics, effective implementation and measure KPIs</li> </ul> <p><b>Financial</b></p> <ul> <li>Manage the A&P to ensure optimum ROI for each of the brands under purview</li> <li>Brand P&L - Analyse brand profitability, revenue and margins with the help of Finance inputs.</li> </ul> <p><b>Process</b></p> <ul> <li>All the marketing related processes e.g. Promo Material Validation SOPs with Medical Team</li> <li>Brand reports – Update brand reports & key initiative updates in a timely manner to report to the management</li> </ul> <p><b>Customer</b></p> <ul> <li>Internal stakeholders – engage, align, educate & support cross functional brand plan development, implementation & measurement</li> <li>External stakeholders – for awareness, education, activation and advocacy – HCPs, Consumers, key opinion leaders in the medical & consumers fraternity.</li> </ul> <p><b>Knowledge, Skills & Competencies / Language</b></p> <ul> <li>Problem solving, strategic thinking, teamwork, effective communication & creativity</li> <li>Basic Financial Management Knowledge & Project Management exposure/ experience is desired</li> </ul> <p><b>Qualifications </b></p> <ul> <li>Training in digital marketing</li> </ul> <p><b>Requirements of the job</b></p> <ul> <li>6-8 years relevant work experience. E.g. MNC pharma, consumer health, healthcare consulting or healthcare communication agency<b> </b></li> </ul> <p> </p> <p> </p> <p>At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.</p> <p>Please note you are leaving the corporate site of Sanofi and are being redirected to our applicant tracking system, Workday, which allows you to apply to our open positions.</p> <p>Please note you are leaving the corporate site of Sanofi and are being redirected to our applicant tracking system, Workday, which allows you to apply to our open positions.</p> Mon, 10/21/2019 - 13:39 1406538 1406538 Scientist II - Analytical Research and Development - Synthetic Chemistry Support https://medfrogs.com/job/scientist-ii-analytical-research-and-development-synthetic-chemistry-support-1404498 <p>Scientist II - Analytical Research and Development</p> <p><strong>Job Description</strong></p> <p>This is a non-supervisory position in USP-India’s Analytical Research & Development Laboratory. In this role, the Scientist - II works on projects including Analytical Method Development for in process samples for synthetic chemistry support. The Scientist II performs a variety of non-routine and routine analytical tests, including evaluation of reference standards, development or validation (as per requirement) of official methods, evaluation of packaging materials and stability studies, and general research in analytical chemistry</p> <p><strong>Roles and Responsibilities</strong></p> <ul> <li> <p>Support to reaction monitoring, scale up and final analysis of samples as per monograph / in-house procedures including method development if required.</p> </li> <li> <p>Prepare development reports for Synthetic Support projects.</p> </li> <li> <p>Involve in project acceptance & approvals.</p> </li> <li> <p>Execute projects per the approved test protocols if assigned.</p> </li> <li> <p>Responsible for preparation of SOPs, protocols, reports, etc.</p> </li> <li> <p>Ensure the projects requirements by coordinating with the Purchasing department.</p> </li> <li> <p>Complete ARD- (USP-NF & CDL) projects within timelines by coordinating with Manager.</p> </li> <li> <p>Responsible for preparation of the records and documents.</p> </li> <li> <p>Ensure that the calibrations of the equipment’s are performed as per the schedule.</p> </li> <li> <p>Prepare, execute and complete IQ/OQ/PQ of new instruments.</p> </li> <li> <p>Indent the required glass ware, chemicals and columns for the ARD projects.</p> </li> <li> <p>Maintain GLP & implement safety procedures while working in Lab.</p> </li> <li> <p>Perform other Projects whenever free from ARD activities.</p> </li> <li> <p>Perform other duties as assigned</p> </li> <li> <p>Preparation and planning for ISO-9001 & ISO- 17025 certification/recertification by participating actively, verification of protocols and related documents and take an active role in the internal as well as external QA audits and address the audit issues in a timely manner.</p> </li> <li> <p>Participates in USP cross-functional teams as appropriate</p> </li> </ul> <p><strong>Required Skills</strong></p> <ul> <li> <p>Proficient with pharmaceutical testing requirements involving compendial methods for reference materials.</p> </li> <li> <p>Expert in HPLC and GC analysis and troubleshooting, proficient in other related analytical instrumentation (IR, KF, UV, and thermal analysis techniques etc.).</p> </li> <li> <p>Knowledge of handling LCMS and GCMS will be added advantage.</p> </li> <li> <p>Working knowledge of computer applications, such as MS Word and MS Excel are required.</p> </li> <li> <p>Good interpersonal skills and proven ability to function in a team-oriented environment are necessary.</p> </li> <li> <p>Proven track record of consistently delivering projects on time and with high quality.</p> </li> <li> <p>Prior experience in a high volume pharmaceutical ARD laboratory or contract pharmaceutical analytical laboratory testing organization is a plus.</p> </li> <li> <p>Takes personal responsibility for delivery of projects to customers.</p> </li> <li> <p>General chapter information, Empower and NuGenesis will be preferred</p> </li> </ul> <p><strong>Required Experience</strong></p> <ul> <li> <p>MSc. in Analytical Chemistry / Organic Chemistry, from a well-recognized University in India or abroad and required not less than 4 years’ experience in Analytical lab.</p> </li> <li> <p>Must have hands on experience in working with chemical methods and handling instruments like HPLC, GC, FTIR, UV-Visible, wet chemistry, etc.</p> </li> <li> <p>Good technical writing and verbal communication skills are required. Good interpersonal skills and proven ability to function in a team-oriented environment are necessary. Understanding of GMP / ISO-IEC 17025 Guidelines is a requirement</p> </li> </ul> <p><strong>Job Location</strong></p> <p>Equal Opportunity/Affirmative Action Employer</p> <p>USP is proud to be an equal opportunity/affirmative action employer. Employment selection and related decisions are made without regard to sex, gender identity, race, age, disability, religion, national origin, color, veteran status or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities.</p> <p>If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please send an e-mail to humanresources@usp.org or call (301) 230-3257 and/or 711 for TTD/TTY service.</p> <p>3rd Party Recruitment Agencies</p> <p>USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.</p> <p>Any unsolicited resumes sent to USP, including unsolicited resumes sent to a USP address, or email address, directly to USP employees, or to USP's resume database will be considered USP property. USP will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. USP considers candidates for whom an agency has submitted an unsolicited resume to have been referred by the agency free of any charges or fees.</p> Mon, 10/21/2019 - 13:31 1404498 1404498 Mechanics Engineer in Bangalore, India at HemoCue America https://medfrogs.com/job/mechanics-engineer-in-bangalore-india-at-hemocue-america-1410675 <ul> <li>Connect with us:</li> </ul> <p><strong>Date Posted:</strong> 10/10/2019</p> <h2>About Us</h2> <p><strong>Products from HemoCue - part of the Radiometer Group, are being used in more than 130 countries</strong>Working with healthcare professionals within various clinical areas all over the world, we have developed a profound understanding of your varying needs. These insights, combined with our extensive knowledge, experience and innovation, help us develop the point-of-care testing solutions of tomorrow.</p> <h2>Job Description</h2> <p><b>About Us</b></p> <p>HemoCue, acquired by Radiometer Medical ApS in April 2013, is a global leader in point-of-care testing. HemoCue AB (Ängelholm, Sweden), introduced in 1982 the first accurate, near-patient hemoglobin test. The company also sells point-of-care tests for glucose, urine albumin, HbA1c, total and differential white blood cell count. Further information, visit www.hemocue.com</p> <p>Radiometer - Make an impact on life. The difference between life and death can be just a few minutes. Radiometer’s diagnostic equipment is of crucial importance to doctors all over the world in their effort to diagnose critically ill patients quickly and accurately. From biotech and software specialists to financial controllers and engineers, all 2500 colleagues are committed and dedicated in their effort to make an impact on the life of others with our high-quality solutions. Radiometer’s leading position in the market has been secured over the last 50 years. Together we continue to raise the bar in acute care and constantly develop in new areas. Radiometer has an annual turnover of more than DKK 3 billion and is owned by US-based Danaher Corporation.</p> <p><b>Description</b></p> <ul> <li>Taking a lead role of mechanical development in projects  </li> <li>Working in cross-functional teams  Creating and sustaining manufacturing documents (CAD)  </li> <li>Creating prototypes with internal and external resources  </li> <li>Verification of design   </li> <li>Able to apply Tolerance analysis and design for reliability techniques  </li> <li>Ability to transform high level customer requirements into technical requirements   Serves as an SME in relevant projects.  </li> <li>Serves as the Core Team member in relevant cross functional projects.  </li> <li>Interact with both business and technical stakeholders to deliver high quality products and services that meets/exceeds business customer, and technical requirements.  Maintains existing products as required to meet safety, reliability, and customer expectations.  </li> <li>Organizes and actively participates in design reviews and project reviews.  </li> <li>Adheres to quality system requirements in the development of new designs including all required documentation.  </li> <li>Flexibility to adhere to Danaher Business System tools and applies them in day-to-day work.  </li> <li>Ensures compliance to organizational policies, procedures and regulatory requirements.</li> </ul> <h2>Job Requirements</h2> <p><b>Qualifications</b></p> <ul> <li>BS in Mechanics Engineering with a minimum of 7 years experiance OR Master’s degree with 3 years experiance or an equivalent combination of education and experience to perform at this level.  </li> <li>No less than 1 years of experience in product development including design, manufacturing, and market use of product.  </li> <li>Experience with IVD and/or Life Science instruments – desired.  </li> <li>Understanding of Product Development Process, Life Cycles Management, and Manufacturing.  </li> <li>Design for manufacturing: Ease of assembly, Cost of Goods, second sourcing.  </li> <li>Must possess strong verbal and written communication skills.  </li> <li>Ability to work independently and on cross-functional teams in a global environment.  Ability to travel as needed.  </li> <li>Works with the multidiscipline R&D team to develop new and innovative designs  Proficient in PTC Creo Parametric  </li> <li>Proficient in Corel Draw  </li> </ul> <p><b>Danaher Corporation Overview</b>Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.</p> <p><small>Please be aware that fraudsters often impersonate companies, like Danaher and our operating companies, to scam jobseekers. We do not make job offers without first meeting the candidate in-person. We also do not ask job applicants to submit by email personally identifiable information, such as social security numbers or bank account details.</small></p> <ul> <li>® 2017 Danaher. All Rights Reserved</li> </ul> Mon, 10/21/2019 - 13:26 1410675 1410675 Centralized Monitor https://medfrogs.com/job/centralized-monitor-1409450 <p><strong>Date Posted:</strong> 9/14/2019</p> <h2>Job Description</h2> <p>IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.</p> <p>ROLE AND RESPONSIBILITIES:<br /> •         Early identification of site-level risk/issue(s) occurring during study conduct and responsible for identification of risk<br /> •         Monitor site performance and make recommendations for timely corrective actions (e.g. Site Telephone Contact or Triggered Onsite Monitoring Visit) <br /> •       Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed.<br /> •         Work in accordance of the Study Central Monitoring Plan.<br /> •         Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.<br /> •         Establish and maintain effective project/ site level communications with relevant stakeholders<br /> •         Maintain relevant project documents.<br /> •         Collaborating with peer business process specialists and promoting cross functional synergies.<br /> •         Project Oversight   to site  management activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation& guidelines.<br /> •         Attend Kick-Off meetings, weekly team meetings, and client meetings, as per the project specific needs.</p> <p>REQUIRED KNOWLEDGE, SKILLS AND ABILITIES</p> <p>•         Advanced knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Familiarity with related systems and software utilized in clinical operations.  <br /> •         Strong written and verbal communication skills including good command of English language     <br /> •         Results and detail-oriented approach to work delivery and output    <br /> •         Understanding of clinical/medical data.<br /> •         Ability to work on multiple projects and manage competing priorities<br /> •         In depth therapeutic and protocol knowledge<br /> •         Strong communication and interpersonal skills, including good command of English language<br /> •         Strong organizational and problem solving skills<br /> •         Demonstrated ability to deliver results to the appropriate quality and timeline metrics<br /> •         Good judgment<br /> •         Ability to manage competing priorities<br /> •         Ability to work across cultures and geographies with a high awareness and understanding of cultural differences.</p> <p>EDUCATION AND EXPERIENCE:Candidates should be life science Post graduates and/or health science background with 2-5 yrs of experience in to Clinical research/Site monitoring/remote monitoring. Experience in Centralized Monitoring will be preferred</p> <p><i>Join Us</i></p> <p>Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.</p> <p>Forge a career with greater purpose, make an impact, and never stop learning.</p> <p><b>Job ID: </b>R1066335</p> Mon, 10/21/2019 - 13:22 1409450 1409450 Senior Software Engineer (Regulated Medical Devices) https://medfrogs.com/job/senior-software-engineer-regulated-medical-devices-1410673 <ul> <li>Connect with us:</li> </ul> <p><strong>Date Posted:</strong> 9/24/2019</p> <p><strong>DIAGNOSTICS: IMPROVE PATIENT CARE, INCREASE QUALITY AND LOWER COSTS</strong>The healthcare industry is changing, and new challenges require new thinking. That's why we don't stop at developing quality clinical diagnostic instruments and assays that enhance your laboratory or network of laboratories. By working with Beckman Coulter, you gain access to a suite of innovations in products, services and business processes that enhance clinical effectiveness and operational productivity.</p> <h2>Job Description</h2> <p><b>About Us</b>Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see.If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at www.beckmancoulter.com.Beckman Coulter is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law. <b>Description</b></p> <p>•Design and Develop Software as per the product architecture and requirements.</p> <p>•Code and unit testing of the feature/modules including appropriate design reviews and code     inspections.</p> <p>•Ensure adherence to the software development processes.</p> <p>•Investigates software / system problems to isolate the root cause and provides innovative     solutions.</p> <p>•Collaborates with cross-functional teams (locally & globally) to ensure product releases meet quality, performance, scalability, reliability and schedule goals.</p> <h2>Job Requirements</h2> <p>•         <b>9-12 years of experience in software development using java technologies.</b> •         <b>Solid experience in architecting, designing and developing java-based solutions.</b> •         <b>Experience with Core Java, JEE5 (JSP/JMS/Web Services/Servlets), Spring, Hibernate, REST, ReactJS, JQuery,</b> •         <b>Experience with working on JBOSS,Tomcat Application/Web Servers</b> •         <b>Must have worked in agile/scrum environment.</b> •         <b>Good knowledge in SQL, PL/SQL, Stored Procedures -preferable</b> •         <b>Work experience in relational DB like Oracle</b> •         Work experience in Json storage like MongoDB or CouchDB is a plus •        Good understanding of software development processes, preferably for a regulated medical devices environment (ISO13485/FDA). •         Experience with Microsoft Team Foundation Server is a plus. •         Ability to work with cross-functional and remote teams. •         Flexibility to work on different areas of the product/platform. •         Good written and verbal English communication. •         Ability to travel as needed (minimal). <b>Diversity & Inclusion</b>At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. <b>Danaher Corporation Overview</b>Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.</p> <p><small>Please be aware that fraudsters often impersonate companies, like Danaher and our operating companies, to scam jobseekers. We do not make job offers without first meeting the candidate in-person. We also do not ask job applicants to submit by email personally identifiable information, such as social security numbers or bank account details.</small></p> <ul> <li>® 2017 Danaher. All Rights Reserved</li> </ul> Mon, 10/21/2019 - 13:13 1410673 1410673 The Clinical Research Data Information Specialist https://medfrogs.com/job/the-clinical-research-data-information-specialist-1411507 <p>Position Location <strong> Rockville, Maryland </strong></p> <p>​The Emmes Company, LLC established in 1977, is a Contract Research Organization (CRO).  Headquartered in Rockville, MD, Emmes employs over six hundred staff worldwide with offices located in Frederick, MD, Tysons Corner, VA, Vancouver, Canada and Bangalore, India.  Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance. </p> <p>Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research.   Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation. </p> <p><strong>Primary Purpose</strong></p> <p>The Clinical Research Data Information Specialist works closely with the National Institute of Neurological Disorders and Stroke (NINDS) and scientific, logistical and administrative support staff from the neurology-specific subject matter experts to develop standardized data collection terminology for use on sponsored clinical trials in over 20 different neurological disease areas.  Duties will include maintaining website components, making database changes and adding new material, consolidating disparate case report forms into a unified template, creating and retrieving reports from the database, communicating with website programming staff, and providing assistance to research staff using the NINDS Common Data Elements website.</p> <p><strong>Responsibilities</strong></p> <ul> <li>Develops and distributes meeting agendas, reports, and materials</li> <li>Makes updates to the <em>Common Data Elements</em> database and website</li> <li>Provide support to the IT staff by consulting and responding to error reports, problems or questions</li> </ul> <p><strong>Experience</strong></p> <ul> <li>Bachelor’s degree (in a scientific discipline preferred) with two years of professional experience in a scientific or health related position or master’s degree in lieu of professional experience</li> <li>Proficiency with web-based searching methodology</li> <li>Familiarity with relational database design and website development</li> <li>Proficiency in Microsoft Office Suite required, especially Excel</li> <li>Strong organizational, time management, and administrative skills with the ability to multi-task and prioritize various ongoing projects</li> <li>Superior verbal and written communication skills: professionalism, accountability and customer service</li> <li>Ability to work independently as a member of a unified team</li> <li>Familiarity with medical terminology specific to neurologic disorders will be beneficial</li> <li>Experience with Drupal websites a plus</li> </ul> <p> </p> <p><em>Find us on LinkedIn - The Emmes Company</em></p> <p> </p> <p> </p> <p><em>Emmes is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.</em></p> <p> </p> Mon, 10/21/2019 - 11:54 1411507 1411507 Manager https://medfrogs.com/job/manager-1409862 <p> </p> <p><u><b>Audit Management</b></u></p> <p>Develop and execute audit management training for subject matter experts</p> <p>Coordinate pre-audit and inspection documents including streamlining information needed from global PV functions and the safety database</p> <p>Liaise with Global Quality and Regulatory Compliance (GQRC), PV International Team and other key stakeholders</p> <p>Conduct mock inspection interviews focused on subject matter expert role-based content as well as general inspection conduct</p> <p>Improve and implement efficient methodologies and tools for the handling of internal audits</p> <p>Maintain a department Corrective and Preventative Action (CAPA) system for findings/observations due to audits, inspections, and quality events,  including developing reports for trend analysis</p> <p>Maintain oversight, guide subject matter experts in developing solid CAPA, and facilitate resolution of CAPA from audits in order to prevent repeat or complex resolution to findings by liaising with GQRC, Pharmacovigilance (GPV&E) and other BMS department subject matter experts.</p> <p>Contribute towards updating relevant sections of the Quality, Standards and Training Manual and quality related sections of the Pharmacovigilance Master File (PSMF) as appropriate</p> <p>Promote the spirit of proactive, continuous quality improvement</p> <p><u><b>Inspection Readiness</b></u></p> <p>Assist with departmental inspections including developing responses to observations and oversight of corresponding CAPA</p> <p>Trend and leverage industry intelligence relating to PV inspections and share results with teams in order to improve the effectiveness of the PV Quality System</p> <p>Promote the spirit of proactive, continuous quality improvement</p> <p><u><b>Qualifications Requires</b></u></p> <p>Bachelors degree, Master degree Preferred, scientific/medical background  (B.S./B.A, M.S.) in Life Science, Nursing, Regulatory Affairs, Chemistry or Pharmacy</p> <p>Minimum of 8 years pharmaceutical experience with a strong preference of 5 or more years in pharmacovigilance, drug development, clinical development, quality and/or regulatory.  </p> <p>Excellent written and verbal skills</p> <p>Excellent skills in influencing and collaborating in order to problem solve</p> <p>Capable to interpret information/data to provide guidance regarding superior business solutions, largely in the form of influencing strong corrective and preventive actions as a result of audit/inspection findings</p> <p>Ability to detect business and regulatory issues and develop solutions to mitigate risk</p> <p>Self-starter with demonstrated ability to work independently and in a matrix, team environment</p> <p>General understanding and adaptation of global safety regulatory obligations from clinical trial to post marketing phases</p> <p>Appreciation of sense of urgency and prioritization of multiple projects and timelines</p> <p>Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.</p> <h3>Working with Us</h3> <p>By fostering a culture of inclusion, we empower this 21st century workforce to achieve our company's mission of helping patients to prevail over serious diseases.</p> <h3>Explore Job Opportunities</h3> <p>A clear purpose. An inclusive culture. The chance to work at the top of your field. These are a few of the reasons Bristol-Myers Squibb is the right choice for your next career move.</p> <h3>Come Meet Our Team</h3> <p>Are you ready for a career where you make a profound difference? We invite you to visit us at one of our events to learn more.</p> <p>For US Applicants Only</p> <p>Bristol-Myers Squibb endeavors to make this website accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact adastaffingsupport@bms.com. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.</p> <p>The Physician Payment Sunshine Act (Sunshine Act) requires Bristol-Myers Squibb to report any transfers of value, including payments made to reimburse interview-related expenses, for candidates who are US-licensed physicians. U.S. licensed Physicians covered by the Sunshine Act include Doctors of Medicine, Osteopathy, Dentistry, Dental Surgery, Podiatry, Optometry and Chiropractic Medicine who are licensed to practice medicine in the U.S. This information will be reported to the Centers for Medicare and Medicaid Services (CMS) on an annual basis and CMS shall post submitted data on its public database. For more information, click here.</p> <p>Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. For our EEO Policy Statement, please click here. If you'd like more information on your EEO rights under the law, please click here: EEO is the LAW and Supplemental Information.</p> Mon, 10/21/2019 - 11:00 1409862 1409862