Clinical Applications Engineer

EMD Millipore Rockland , MA 02370

Posted 3 months ago

Who We Are: EMD Serono is the North American biopharma brand of Merck KGaA, Darmstadt, Germany - a leading science and technology company - focused exclusively on specialty care. For more than 40 years, the brand has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas.

Your Role: You will configure, install, update, upgrade, maintain and repair and provide training on an innovative suite of medical devices, software and services geared toward the In Vitro Fertilization (IVF) lab. This equipment includes hardware and software components.

Who You Are:

  • BS in Engineering; Electrical or Instrumental Engineering, specifically, preferred; MBA or advanced degree preferred

  • Minimum of 7 years' experience in pharmaceutical/biotech industry

  • Experience with computer based medical devices and/or medical imaging systems in a clinical setting

  • Understanding of the US biotech specialty space and of pharmaceutical and promotional compliance guidelines and regulations required

  • Working knowledge of networking basics- TCP/IP, DNS, DHCP, Wireless Access

  • Working knowledge on the use of calibrated measuring tools such as pressure meters, thermocouple thermometers, flowmeters and multimeters

  • Experience in fertility and/or endocrinology is a very strong plus

  • Experience with different lab setups and workflows, along with experience managing daily tasks of a lab are preferred

  • Understanding of the US biotech specialty space with demonstrated ability to learn and master complex business environments

  • Leading people, without formal authority, a strong plus

  • Demonstrated ability to collaborate effectively with field based teams with a capability to access and influence various functional areas and motivate groups to action a must

  • Ability to train diverse audiences effectively

  • Ability to demonstrative creative and innovative strategies for business success

  • Excellent writing and verbal presentation skills and an ability to translate complex information into succinct and impactful messages successfully with medical professionals at all levels

  • Launch experience a strong plus

  • High proficiency in Microsoft Word, Excel, Outlook, PowerPoint to document and communicate concepts as well as Microsoft software installation and troubleshooting

  • Position requires both domestic and international travel up to 80% of time; preferred East coast location and within reasonable distance from a major airport

Job Requisition ID: 178409

Location: Rockland

Career Level: D - Professional (4-9 years)

Working time model: full-time

Nearest Major Market: Boston

Job Segment: Immunology, Medical, Neurology, Clinic, Endocrinology, Healthcare


See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Head Regional Clinical Operations Americas

Merck Kgaa

Posted 1 week ago

VIEW JOBS 11/9/2018 12:00:00 AM 2019-02-07T00:00 Your Role: The Head of Regional Clinical Operations for the Americas you lead Site Relationship & Operational Lead and the Clinical Research Manager teams within the region. * As head of Site Relationship & Operational Leads in the Americas, you are accountable for: * Providing direction to the Site Relationship & Operational Leads (SROLs) in the region to ensure that global trials are conducted with concern for ethics and patient safety and in compliance with Good Clinical Practice, internal policies and guidelines and local regulations. * Ensuring that SROLs oversee CRO work as well as develop and maintain excellent relationships with trial sites and the company's commercial organizations in the region * Continuously monitoring performance of assigned staff against applicable practices and expectations, addressing any deficiency and providing coaching and mentoring as required to maintain high-performance teams * Ensuring development of communication skills of all SROLs under responsibility * As head of Clinical Research Managers (CRMs) in the Americas, * be accountable for clinical trial management of global Phase IV, local and/or regional clinical trials of marketed products, and registrational studies for local products for all countries within own region and therapeutic areas which includes: * Ensuring that local/regional clinical trials are executed and managed based on agreed budget, timelines and quality standards * Ensuring compliance with local/regional guidelines, GCP as well as alignment of systems and processes to Company and global standards (performance, quality, timelines) * Ensuring that the assigned staff members adequately fulfill their tasks and responsibilities within clinical trials according to agreed timelines, quality and budget and according to ICH-GCP, regulatory requirements and Company standards * Supporting assigned staff in reaching clinical trial objectives * Providing an interface with regional/local Medical Affairs organizations and ensuring alignment on trial strategy * Manage the implementation and integration of organizational changes or new roles and responsibilities and adjust and incorporate changes to existing roles as appropriate. * Lead and steer site management as well as central coordination for developing long-term relationships with clinical investigators, enhancing the image and reputation of the company and for providing an interface between the company, the investigator and the service provider across multiple countries * Anticipate and mitigate issues or risks in the region or countries with sites/investigators as well as CROs * Lead and coordinate study management for local clinical trials across countries in own region, phases and therapy areas * Ensure alignment and support of CRMs vs. local / regional commercial organization priorities for clinical trials * Ensure and drive CRMs support for local medical strategy across the portfolio within own countries * Oversee CRMs work/interaction with CROs in county to ensure local / regional trials are delivered within desired quality, timelines, and costs Who You Are: * Advanced degree in life sciences or business * More than 10 years of industry experience with a biotech, pharmaceutical or CRO, including experience in clinical trial management and working in or managing clinical monitoring * At least 5 years of people and resource management, ideally in a multifunctional or multinational setting * Demonstrated excellent organizational ability: time management, prioritization, able to handle and oversee multiple tasks simultaneously * Demonstrated solid interpersonal skills * Demonstrated good people management and coaching skills. * Deep understanding of regional aspects/variability of regulatory aspects and conduct of clinical trials in countries / across geographies * Ability to manage SROLs and CRMs across multiple countries across the entire portfolio * Long-term experience in managing CROs * Understanding of critical Health Care stakeholders across geographies * Ability for domestic and international travel up to 50% of the time Job Requisition ID: 183959 Location: Rockland Career Level: E - Professional (10+ years) Working time model: full-time Merck Kgaa Rockland MA

Clinical Applications Engineer

EMD Millipore