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Fresenius Medical Care North America Sr. Clinical Innovation Manager in Waltham, Massachusetts

Job ID 2100005B

Available Openings 1

PURPOSE AND SCOPE:

Acts as the clinical product expert for respective product line(s) and is responsible for defining customer requirements for new product and services development and ongoing product/service improvements for the product line. Deals effectively with many disciplines both internally and externally which affect the overall success or failure of the product center.

Must interact with many disciplines in order to help drive the business; however, those individuals do not have direct reporting responsibilities to the Sr. Clinical Innovation Manager. Must possess strong leadership qualities, particularly in motivating people in other disciplines to assist them in the execution of the clinical marketing plan.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Acts as the subject matter expert for the on-label use of respective product line(s) and supporting documentation.

  • Collaborates with product management to conduct quantitative and qualitative market research with customers in order to develop the product requirements definition for new and existing products and services.

  • Defines customer requirements for new and existing products and services.

  • Develops and manages limited product releases (LPRs).

  • Participates in market and competitive analyses and in the development and implementation of marketing plans to meet the strategic goals of the product line(s).

  • Serves as central marketing point of contact for technical questions from the sales organization and health care providers; confers with internal product experts and the medical office when necessary; provides timely responses and guidance for on-label product use. Refers off-label requests to the Medical Information & Communications office.

  • Consults with cross-functional teams to determine course of action in order to translate recommendations into product and program improvements. Acts as the clinical liaison for the product line between the RTG Sales, Clinical Staff, Medical Office, Marketing, Customer & Technical Services, Quality, Regulatory, Legal, Compliance, Global R&D, Global Manufacturing and Operations (GMO), and customers. This includes product and service training and updates for these cross-functional teams.

  • Work with product management and marketing communications teams to develop marketing communications, clinical support, & promotional and merchandising tactics consistent with the overall product line strategy.

  • Acts as liaison between RTG Sales, Clinical, Quality, and Product Management on the identification of quality issues to develop product line improvement strategies, including enhancement of training tools and techniques, as well as recommendations for technical modifications.

  • Communicates product or service needs to product management to collaborate on a resolution strategy. Such needs may include, but are not limited to: education and product line support needs, quality issues, new or existing product use, and/or clinical practices.

  • Participates in Corrective Action Preventive Action (CAPA) activities, Field Action Decision Form (FADF) completion, Patient Safety Committee (PSC) meetings. Responsible for presenting marketing team’s response to all field actions and quality issues.

  • Reviews patient facing documentation regarding recalls, FADFs and other materials to ensure it is at a correct reading level and accurately explains the information.

  • Performs unstructured testing to simulate customer use upon request by R&D.

  • Performs verification of product line user guides/instructions for use on production-quality equipment annually and upon request.

  • Implements and complies with International Standard ISO Regulations and Good Manufacturing Practice for Medical Devices, 21 CFR part 820.

  • Participates in risk analyses, offering clinical input where appropriate.

  • Develops and implements comprehensive multi-disciplinary staff training programs on product line, as needed.

  • Applies and adheres to company SOPs for Design Control and Change Control for equipment, disposable products and literature items pertaining to Instructions for Use (IFU) and promotional materials.

  • Conducts train-the-trainer sessions for new and existing products, services, and support materials on a regular basis with the Clinical Support Specialists and/or Medical Support Specialists to ensure on-label use and up-to-date information is delivered.

  • Conducts product demonstrations with customers at meetings and symposia, as requested.

  • Participates in competitive analysis, monitoring, and communication to key stakeholders, as needed.

  • Collaborates with the Sr. Clinical Education Manager to define the clinical education and support needs for the market and provide product expertise to assist in the development of these tools.

  • Participates in the Promotional Materials Review Committee, as needed.

  • Attends trade shows and scientific congresses related to the renal market.

  • Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.

  • Assist with various projects as assigned by a direct supervisor.

  • Other duties as assigned.

PHYSICAL DEMANDS AND WORKING CONDITIONS :

  • The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Most of the work will be performed within the employee’s home office or the corporate offices.

  • Up to 25% travel will be required to conduct business at company manufacturing sites, customer clinics, and trade shows.

  • Some light set-up and break-down may be needed. Hazards include muscular strain from computer-operating procedures and lifting luggage while traveling.

EDUCATION :

RN or BSN required; Certification in nephrology nursing or dialysis nursing preferred.

EXPERIENCE AND REQUIRED SKILLS:

  • Minimum of 5-8 years of clinical experience in hemodialysis and/or peritoneal dialysis is required; with a Master’s Degree only 3 years of experience required.

  • 2 to 3 years of experience in Healthcare Marketing/Product Management is preferred.

  • Experience in Project Management is preferred.

  • Proficiency with Microsoft Excel, PowerPoint, and Word.

  • Proficiency with iOS and Android software operation is preferred

  • Analytical and problem solving ability, excellent interpersonal and communications skills, creativity and business acumen, multi-tasking and project management skills.

  • Strong clinical presentation skills and the ability to present to audiences of various sizes and educational backgrounds.

  • Demonstrated track record of success and career progression.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

ADDENDUM:

Sorbent Therapy

  • Supports the development of sorbent therapy and applications in both home and institutional settings.

  • Works with all members of the PAK Project in all phases of the product life cycle.

  • Ensures device meets end user needs and serves as the face of the clinical end user. Actively participates in the research and development process, system testing not limited to verification and validation, customer training process, and customer support.

  • Serves as a resource for entire PAK Project team for ongoing product evaluation and enhancements.

  • Ensures sorbent therapy/products are relevant to current clinical practice. Anticipates future trends that will require enhancements.

  • Supports the development of sorbent therapy and applications in both home and institutional settings.

  • Supports the clinical perspective of Research and Development of existing and future Sorbent products.

  • Supports product development as a clinical consultant/resource throughout all phases of development.

  • Supports the HFE process for sorbent devices as needed.

  • Supports clinical trials including monitoring trial treatments at site locations as needed, maintaining and documenting communication with engineering as needed. Ensures good clinical practice throughout the study, documentation, and record maintenance in accordance with ISO 14155.

  • Participates in AAMI meetings as scheduled. Communicates appropriate changes in the regulations to team members. Provides clinical input on the clinical requirements under regulatory/quality systems to include human factors testing requirements, AAMI requirements, ISO, IEC and 21 CFR part 820 as needed.

  • Provides clinical expertise on the clinical requirements under regulatory/quality systems to include human factor testing requirements, AAMI standards requirements, ISO, IEC and 21 CFR part 820.

  • Supports the task to monitor and catalog important clinical papers that assist in the selling of products.

  • Support company engagement activities with ESRD constituencies such as clinical thought-leaders, clinical/patient organizations, clinical standards-setting organizations such as ISO/AAMI/ANSI, CMS inspectors, KDOQI, ANNA, and patient advocacy groups such as AAKP, NKF, etc.

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

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