דרושים Pre Authorization Specialist ב-Boston Scientific ב-United States, Santa Clarita

Your responsibilities will Include:

• Support detailed project planning in support of major project, product/process transfer etc.
• Co-coordinating the activities of any BSC allocated project resources.
• Support the PM to identify and manage project dependencies and critical path items while ensuring project quality and utilizing and following appropriate methodologies.
• Development of and adherence to project contract or terms and conditions.
• Liaise with project manager, other team members, and functional management as necessary and effectively communicates project expectations and deliverables to team members in a timely and clear fashion.
• Development and implementation of appropriate supporting documentation and project management tools (meeting notes, decision log, risk matrix, Terms and Conditions)
• Prepare project status updates
• Support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support.
• Identify and escalate unresolved obstacles to the success of the project.
• Participates in the planning, execution, and finalization of projects according to strict deadlines, within budget, and by following organized and repeatable procedures.
• Conducts project post mortems and communicates lessons learned in order to identify successful and unsuccessful project elements.
• Use critical thinking to offer new ideas and potential improvements to the project plan

Required qualifications:

• 3+ years related experience to include leading or managing projects
• 2 yrs experience in data management and technology systems implementation
• Strong data analysis skills
• Strong familiarity with Microsoft Tools and ability to learn software quickly
• Concise verbal and writing communication

Preferred qualifications:

• 3+ years medical device industry experience
• Preferred experience in process development and leading continuous improvement
• Experience in creating & facilitating communication to stakeholders
• Bachelor’s degree

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Shift Hours:5:30 am-5:00 pm PST

Your responsibilities will include:

• Managing a pipeline of candidates through daily outbound calls to connect, educate and nurture patients through all stages required prior to procedure.
• Update CRM systems by entering in candidate information received via phone, website, care cards, local therapy awareness events as well as from physician offices and hospitals.
• Articulate our products clearly and concisely over the phone and adapt conversations based on the needs of the patient.
• Answer patient questions, handling objections and sending additional information, if needed.
• Meet daily performance metric requirements to achieve quarterly goals.
• Remain knowledgeable on our products, therapy indications, competitors, and clinical studies.
• Maintain regular communications with your local field sales team to stay up to date on regional market updates and identify sales opportunities.
• Proper utilization of sales procurement software as well as performance improvement tools and knowledge management systems.
• Position may require travel to meet with local sales reps, physicians, and customer staff.
• Perform other duties as assigned, including special projects.

Required qualifications:

• 0-1 Years with High School Diploma and/or
• Equivalent experience, training , or apprenticeships
• Strong analytic, problem-solving, and critical thinking skills as well as excellent verbal and written communication
• Ability to work independently and effectively within a team
• Good organizational skills and the ability to multitask
• Picks up on technical things quickly; can learn new skills and knowledge; is good at learning new industry, company, product, or technical knowledge
• Ability to work in a fast-paced environment and be motivated in a metric/goals-based setting
• Experience using CRMs
• Demonstrates strong active listening skills to understand patient needs and respond appropriately
• Ability to engage in an empathetic and understanding manner
• Provides support to sales representatives, ensuring seamless execution of patient engagements

Preferred Qualifications:

• Bachelor’s Degree
• Salesforce experience

Maximum Salary: $ 73008

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Your responsibilities will include:

• Confirms case information is complete and supports medical necessity.
• Obtains additional information from the physician or patient as needed.
• Follows up timely on assigned tasks to ensure optimal case progression.
• Communicates internally and externally to resolve case related issues.
• Submits prior authorization requests by phone or fax to the payer.
• Manages incoming faxes and correspondence, distributing to Case Managers in a timely and accurate manner.
• Prioritizes tasks according to urgency.
• Applies pressure on health plans that refuse to review based on negative or absent coverage policy for the procedure.
• Drafts all case related communication to physicians, patients and payers in a clear and concise manner.
• Documents all case activity and correspondence for cases in a timely manner to provide chronological details of case progress.
• Acts as a resource for fellow team members and new employees.

Skills:

• Demonstrated ability to navigate the prior authorization process with commercial and government payers.
• Strong ability to read clinical records and extract pertinent information for submission.
• Demonstrated knowledge of payer medical policies and criteria requirements.
• Ability to follow process and protocol and communicate when/if changes are needed.
• Ability to work within multiple software systems.
• Ability to adapt as the needs of the business change or evolve.
• Excellent verbal and written communication skills.
• Excellent interpersonal skills.

Required qualifications:

• 1-2 Years with High School Diploma and/or equivalent experience, training , or apprenticeships
• Minimum 2 years commercial insurance prior authorization experience.
• Secure home office space with ability to protect HIPAA sensitive materials.
• Must be willing to travel as needed (<5%).

Preferred qualifications:

• Pain management or spine specialty preferred.

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

The Regulatory Affairs Specialist II will be a part of the Neuromodulation Regulatory Affairs team and will support the regulatory submission activities to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwide. In this role you will participate in activities to ensure compliance with worldwide regulatory requirements.Your responsibilities include:

• Support the preparation of submissions (i.e. PMA, PMA supplements, CE marking applications, etc.) to obtain various worldwide approvals to commercially distribute products
• In conjunction with Clinical Research, support the preparation of applications (i.e., IDE, IDE supplements, Investigator Brochure) for conducting clinical investigations in U.S., Canada, Australia and EU countries
• Prepare required submissions (progress reports, etc.) to facilitate the continuation of clinical studies
• Participate in the review and submission activities (annual reports, change notifications, etc.) to support the maintenance of marketing approvals
• Support product registrations for international markets as required.
• Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects
• Other duties as assigned

Required qualifications:

• Bachelor's Degree or equivalent work experience
• A minimum of 3 years' work experience in regulatory affairs or related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility)
• Knowledge and experience with U.S. FDA, EU, and/or international regulations and standards

Preferred qualifications:

• Prior experience with class III Medical Devices
• Minimum of 3 years’ experience with Post Market Assessment
• Interpersonal, communication and negotiating skills.
• Effective written and oral communication, technical writing and editing skills
• Works well in fast-paced cross-functional team environments
• RA certification (by Regulatory Affairs Professional Society)

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

About the role:

This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Valencia, CA (preferred), Sunnyvale, CA, or Arden Hills, Maple Grove or Minnetonka, MN. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Your responsibilities will include:

• Acts as a company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submissions strategy/regulatory pathway development testing requirements, clarification and follow-up of submissions under review
• Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, 510(k)s, Annual Reports, and CE Mark submissions under MDR
• Supports and implements the development of domestic and international strategies for Class II and III medical devices for new and modified medical devices
• Assists with departmental policy and procedure implementation
• Assists with Regulatory Affairs training to cross functional groups
• Represent RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts
• Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations
• Reviews device labeling and advertising materials for compliance with global submissions and applicable regulations; analyzes and recommends appropriate changes
• Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations
• Support international geographies to gain and maintain product approvals
• Support efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing
• Supporting regulatory audits, as required

Required qualifications:

• Bachelor’s degree, minimum
• 4+ years Regulatory Affairs or related discipline in medical devices (R&D, Quality, Clinical, Biocompatibility, Labeling, etc.)
• Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as various US PMA supplements, 510(k)s and EU MDR technical documentation
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

Preferred qualifications:

• Previous experience in the medical device industry with Class II or III device submissions
• General understanding of product development process and design controls
• Working knowledge of FDA, EU and international regulations
• Ability to manage several projects
• Effective research and analytical skills
• Effective written and oral communication, technical writing and editing skills
• Works well in fast-paced cross-functional team environments
• Team player with excellent interpersonal skills

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Your responsabilities will include:

• Confirms case information is complete and supports medical necessity. Obtains additional information from the physician or patient as needed.
• Follows up timely on assigned tasks to ensure optimal case progression.
• Communicates internally and externally to resolve case related issues.
• Submits prior authorization requests by phone or fax to the payer.
• Manages incoming faxes and correspondence, distributing to Case Managers in a timely and accurate manner.
• Prioritizes tasks according to urgency.
• Applies pressure on health plans that refuse to review based on negative or absent coverage policy for the procedure.
• Drafts all case related communication to physicians, patients and payers in a clear and concise manner.
• Documents all case activity and correspondence for cases in a timely manner to provide chronological details of case progress.
• Acts as a resource for fellow team members and new employees
• Demonstrated ability to navigate the prior authorization process with commercial and government payers.
• Strong ability to read clinical records and extract pertinent information for submission.
• Demonstrated knowledge of payer medical policies and criteria requirements.
• Ability to follow process and protocol and communicate when/if changes are needed.
• Ability to work within multiple software systems.
• Ability to adapt as the needs of the business change or evolve.
• Excellent verbal and written communication skills.
• Excellent interpersonal skills.

Required qualifications:

• 1 Year with Associate in Arts degree/diploma, or an equivalent combination of education/work experience
• Secure home office environment that ensures the protection of materials sensitive to HIPAA regulations.
• Must be willing to travel as needed (<5%).
• Minimum 2 years commercial insurance prior authorization experience.

Preferred qualifications:

• Pain management or spine specialty preferred.

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.