Compliance Manager, BIOTRONIK NEURO

Biotronik

  • Lake Oswego, OR
  • Permanent
  • Full-time
  • 2 months ago
Compliance Manager, BIOTRONIK NEUROAs one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.The Compliance Manager of BIOTRONIK NEURO will build and drive key program elements and activities associated with the management and continuous improvement of BIOTRONIK NEURO's Compliance program. The Compliance Manager will operate in a multi-disciplinary and interdepartmental capacity, will enact controls, develop appropriate compliance processes and guidelines, and assure adherence, thereof and elevate employees' understanding of compliance. The Compliance Manager is a recognized subject matter expert, relied upon throughout the company, in various elements of BIOTRONIK NEURO's Compliance program. Reporting of the Compliance Manager position will be directly to the President.Your Responsibilities
  • Collaborates with the neuromodulation leaders in the development, presentation and execution of global health economic and reimbursement strategies and develops economic selling tools (budget impact models, value dossiers, reimbursement guides, etc.) to support and define market development opportunities and drive revenue growth
  • Serves as the HEOR research expert for NRO products and will assist in the development and execution of pre & post approval studies
  • Lead the internal and external communication of economic value proposition and of scientific results to achieve maximal scientific impact and commercial success of NRO products
  • Leads market access/reimbursement strategies across NRO product portfolio, including developing and executing U.S. and global market access tactics to accelerate market development, patient access to care and provider access
  • Develops and executes strategies to impact health policy changes and options to support the value of innovation and NRO neuromodulation technology solutions
  • Helps to determine “go/no go” investment decisions around new technologies
  • Develops and empowers the reimbursement team to deliver market access and associated evidence strategies and contribute expertise to product strategies and decisions
  • Communicates value to internal and external stakeholders to advance patient access to care
  • Builds, maintains and expands key opinion leader relationships
  • Works collaboratively with internal and external stakeholders to create partnering opportunities with medical scientific societies and industry associations
  • Leads the response to value reviews of NRO products by external organizations, as appropriate and in alignment with commercial
  • Partners with Government Affairs, Marketing, Clinical Affairs, Regulatory, the United States and International Healthcare Economics as well as other teams throughout the product life cycles (product development, program management, clinical studies and commercialization) for the neuromodulation product portfolio to ensure these products have strong value propositions in an environment of increasing health economic challenges
  • Collaborates with new product development teams to ensure health economics and reimbursement models are incorporated into product development plans and timelines; ensures all necessary new product development deliverables are completed on time
  • Assesses health economics and reimbursement opportunities and challenges facing the organization and/or therapy emerging technologies and commercially marketed products and communicate business impact to senior management
  • Identifies opportunities to develop economic analyses (i.e. cost-effectiveness, budgetary impact, etc.) for key technologies and applicability of analyses globally
  • Builds and formulates collaborative relationships with Healthcare Economics professionals globally for neuromodulation products
  • Monitors, interprets, and summarizes changes in the external environment (regulatory/reimbursement changes, managed care arrangements, etc.) produces internal communication strategies on threats and opportunities with suggested action plans
  • Partners with the United States and International Divisions Healthcare Economics teams in developing and regularly updating the “reimbursement toolbox” for use by various stakeholders in clinical and economic settings
  • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
  • Performs other related duties and responsibilities, on occasion, as assigned
Your Profile
  • 8+ years of experience in medical device reimbursement and reimbursement strategy and a combination of health economics, outcomes research, public policy and successfully developing and implementing strategies with CMS, US commercial payers and payers in Europe and Asia
  • A Bachelor's degree is required (an advanced degree is preferred) in public policy/health, political science, government, business or related field
  • MBA degree is preferred
  • 5+ years of experience leading a multi-disciplinary Health Economics and Reimbursement/ Market Access team
  • Experience working with health technology assessment organizations/payers and professional societies to enable reimbursement strategies and tactics
  • Motivational and collaborative leadership style with a track record for building strong teams and cross-functional partnerships
  • Must have solid understanding of business and commercial acumen and demonstrated ability to analyze complex situations and make sound business decisions
  • Must have exceptional communication skills, ability to influence internal and external partners
  • Must be familiar with and have the ability to engage government affairs, global communications, patient engagement, professional societies and reimbursement coverage to drive strategic decisions for the company
  • Must be self-motivated, goal-oriented and approach their work with professionalism and a passion for helping patients
  • Demonstrated knowledge of U.S. and global healthcare systems including expertise in health care financing, reimbursement policies related to the device industry, and technology assessment
  • Must have strong independent project management skills
  • Must have strong analytical and prioritization skills with the ability to manage several projects simultaneously and meet deadlines in a timely manner
  • Must have excellent interpersonal skills and strong strategic management skills
  • Must be able to work, direct, and take direction with all levels of management
  • Must have ability to understand complex disease states and technical product information
  • Ability to work in a highly matrixed and geographically diverse business environment
  • Ability to work within a diverse team and as an individual contributor in a fast-paced, changing environment
  • Ability to leverage and/or engage others to accomplish projects
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Strong organizational and follow-up skills, as well as attention to detail
Travel Requirements:Ability to travel approximately 50%, including internationally.Supervisory Responsibilities:Responsible for supervising a team of direct reports.Work Environment:This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.This is a largely sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to talk and hear.Position Type/Expected Hours of Work:This is a full-time position. Standard days of work are Monday through Friday. Hours of work may vary depending on time zone supported. Occasional evening and weekend work may be required as job duties demand.Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.Location: Remote out of Lake Oswego, OR | Working hours: Full-time | Type of contract: UndefinedApply now under: www.biotronik.com/careersJob ID: 61158 | BIOTRONIK NRO INC. | USAWe are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.

Biotronik