Operations Manager
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Date Posted:
4/5/2010
Job ID:
1710
Company:
The Parent Company in Germany is expanding to the US. The clinical development and subsequent approval of monoclonal antibody therapies in America for the treatment of oncological diseases are the main goals of Fresenius Biotech North America (FBNA). The Senior Manager of Regulatory Affairs will assist, guide and support the development of oncology biopharmaceutical products from the standpoint of local, state, federal and international laws, guidelines and regulations. He or she will contribute to the planning of pre-clinical experimental designs, manufacturing issues, quality assurance, clinical trials of the investigational drugs, and post-marketing surveillance. The company is an integrated provider of dialysis products and services. The company provides hemodialysis and peritoneal dialysis products, supplies and services for the treatment of renal disease in over 100 countries.Fresenius Medical Care provides a complete line of products for hemodialysis and peritoneal dialysis to support all aspects of patient treatment to optimize the therapy outcome. Hemodialysis Products To continuously improve quality of life and treatment outcomes, Fresenius Medical Care takes a systems approach to adequate treatment: § Machines for Hemodialysis, Hemodiafiltration, Hemofiltration, Acute Dialysis and Plasmafiltration § Low-Flux Dialyzers (Fresenius Polysulfone®) § High-Flux Dialyzers (Fresenius Polysulfone®) § Hemofilters for acute and chronic renal replacement therapy § Plasmafilters § Dialysis flluid filters § Blood lines § Dialysis cannulae § Dialysis fluids § Dialysis concentrates (liquid, dry) § Hemofiltration solutions § Irrigations solutions § Disinfectants § Water treatment systems § Analysis devices § Data management systems Peritoneal Dialysis Products In recent years, Fresenius Medical Care has proven its leadership in product innovation for dialysis products by contributing industry breakthroughs: § Machines and tubing systems for Automated Peritoneal Dialysis (APD) § Peritoneal dialysis solutions § CAPD systems § CAPD double bag systems § Peritoneal dialysis catheters § Accesories. More than a quarter-century of experience in dialysis, innovative research, the global leader in dialysis services and dialysis products: This is Fresenius Medical Care. Patients with kidney disease can now look toward the future with much more confidence thanks to our innovative technologies and treatment concepts. We give them a future – one with the best-possible quality of life. In order to meet the increasing demand for modern dialysis, we are working diligently to further the growth of our company. With more than 45,000 employees, we are pursuing goal-oriented strategies for continuous technological leadership. As a fully vertically integrated company, we offer products and services for the entire value chain in dialysis. The highest medical standards are our benchmark. This is our commitment to our patients, our partners in the health care system and our investors, who trust in the future and earnings ability of our company. ..............................................medical device, research, dialysis, health care, kidney disease, therapy, technology, animal trials, nephrology, drugs, treatment, bloodlines, clinical, hemodialysis and peritoneal dialysis products.
Location:
NM
Reports To:
Director Operations
Salary:
56-85k
Education:
BA degree required with concentration in Business or Healthcare management OR Clinical Manager with demonstrated management capabilities, OR RN with a business degree
Requirements:
3-5 years business or management experience in a healthcare program.
Demonstrated understanding of financial theories and principles required.
Financial modeling experience a plus.
Excellent organizational and prioritization skills.
Excellent computer skills with proficiency in Microsoft and SAP software applications.
Excellent interpersonal and communication skills – oral and written.
Able to work in a fast paced environment.
Attention to detail and accuracy required.
Process oriented.
It is primarily financial and practice management. covering direct patient care clinics with a focus on development of quality indicators.
Duties:
Under direction of the Director of Operations provides support, assistance, and information to an assigned group of clinics to assist and promote efficient and effective operational functioning of the clinics and programs. Provides data information to the Clinical Managers regarding the finance, quality and operations performance indicators on the current scorecard to include but
not limited to: Ultrascore, Primary Quality Indicators, Profit and Loss (P&L) Statements, Commercial Mix Improvement, Revenue, Organic/Same Store Growth Opportunity, TAP, Total Operating Costs (CPT) including medical supplies utilization/efficiency, Pharmaceutical Utilization (EPO), ancillary management, and EBIT.
Provides analyses and reporting of the finance, quality and operations performance indicators on the scorecard to the Director Operations. Collects and analyzes the appropriate data collaborating with the pertinent personnel to verify the accuracy of the data. Researches, conceptualizes and defines problems to consider resolution options. Makes recommendations for solutions to Director Operations. Assists with implementation of solutions as needed.
Assists clinical managers in achieving optimal outcomes of the performance indicators on the scorecard. Monitors performance to goals providing actionable business information such as the identification of trends and areas of concern. Researches anomalies and provides recommendations for process improvements as needed. Assists with implementation of
improvements as needed. Assists with the collection and organizing of the CQI data to evaluate the CQI process. Facilitates and drives the clinic CQI processes and reports status to Director Operations. Attends facility and program CQI meetings as needed. Audits and analyzes clinical and facility operations processes and documentation making recommendations for improvement
as appropriate. Assists with the collection, compilation and organization of data such as performance indicators for interpretation by senior management Conducts billing and various ad hoc operations audits as needed and collaborates with internal and external auditors on clinic audits as appropriate. Promotes effective inventory management and the practice of cost containment strategies through collaboration with Materials Management department to monitor the appropriate functioning of the supply chain to ensure the efficient and effective provision of required supplies and products to facilities. May act as the clinic Chief Executive Officer as needed. Takes a lead role in coordinating record and database maintenance within the clinics. Monitors and maintains databases to track Discharges and Commercial Patients. Identifies trends, identifies and researches issues and concerns, ensuring the appropriate personnel are notified and that corrective actions are taken in a timely manner. Acts as the primary liaison regarding OSHA Compliance collaborating with the corporate Risk Management and Health and
Safety department as needed. Under the direction of the Director Operations, performs regulatory risk audits per the QAI calendar and other audits including OSHA, and audits to ensure compliance with all local, state and federal requirements. Ensures appropriate physical plant maintenance of facilities – collaborating with clinic and maintenance personnel as appropriate. Monitors and follows through on facility project maintenance. Ensures operating procedures in clinics are in compliance with all applicable local, state and federal regulations and company
standard operating procedures. Under the direction of the Director Operations, ensures all FMS business policies, procedures and systems are implemented by the appropriate personnel in the area including compliance with ethical business practices. Assists with the research and analysis required for the development of business strategies. Assists clinic with internal and external audits acting as the liaison with the company compliance audit and internal audit departments as needed. Works with external auditors providing information, answering questions and researching issues as required. Assists with the hiring and on-boarding of all clinic staff. Supports HR processes and audits as appropriate – including but not limited to employee file maintenance, pre-hire checks, and the tracking of training requirements. Tracks and analyzes commercial growth/mix. Identifies trends and researches issues and concerns, ensuring the appropriate
personnel are notified and that actions are taken in a timely manner. Maintains current knowledge of software applications, reports and other tools to effectively provide operations support to the clinic group. Develops and implements new techniques for operations analysis and solutions as appropriate. Develops best practice solutions for performance.
Performs special projects and ad hoc analyses are requested by division management.
Expert in Drug Development, Regulatory Strategy and Quality Systems for Pharmaceutical and Biotechnology companies
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