• Deliver forward-thinking clinical insights derived from analyzing clinical utilization patterns and member behavior impact on medical costs. • Recommend clinical programs and services aligned with customer strategy to influence short‑ and long‑term results. • Analyze, synthesize, and present clinical findings paired with actionable recommendations in customer‑facing meetings. • Serve as a trusted clinical resource on population health, industry trends, and health disparities. • Collaborate across the organization to align strategies between customers and the health plan. • Contribute to customer population health strategies across the clinical continuum. • Create and propose solutions to improve member health, including leveraging community resources and partnerships in the Eastern region.

• Provides advanced level of hands-on Organization Development & Design (OD&D) work • Provide consulting, service partner and/or leader enablement through the design & development of measurement, analytics & visualization tools • Design methodologies informed by stakeholder expectations • Liaise with Client: Primary and/or Strategic project / engagement oversight • Analyze and review proposals, provide thought leadership & encourage creative problem solving • Evaluate the short- and long-term effectiveness of the implemented solution • Provides solutions in organizational capability design • Encourage consultant development & increase team capacity • Maintain a working knowledge of applicable federal, state & local laws / regulations

Job Title CCNA Certified Technical Consultant - Patient Monitoring (Located near Louisville, KY) Job Description Allow your passion for improving lives to shine in this role where you’ll be responsible for customer relationship management through the effective application of technical knowledge to install/implement, service, test, and troubleshoot complex solutions on IT networks to ensure a high quality of service in delivering real time patient data requirements. Your role: - Provide technical recommendations that best suit the environment based on customer requirements, support the transition from a break fix operating model to a customer solutions focused operating model. Drive continuous improvement of implementation methodology and service offerings; actively support to implement service strategies to achieve customer loyalty. - Actively participate as a member of the regional work team, collaborating with a diverse team of internal and external resources to include clinical, sales, and service partners. Coordinate project resources and tasks, enabling team members to focus on customer deliverables. - Perform all administrative duties within established Philips, State, and Federal regulatory requirements and timeframes including timesheets, service work orders, expense reports, Field Change Orders (FCO), preventative maintenance (PM), installation documents, site and service documentation, and other related paperwork. Adhere to established training, quality, and safety requirements. - Install complex, multi-phased systems comprised of IT infrastructure and patient monitoring equipment in both clinical and non-clinical environments (build, deploy, and/or integrate solutions). Provide a technical review of system configuration to ensure viability of system performance during implementations; diagnose and resolve electronic, networking, and mechanical problems. - Approximately 70% travel across the specified geography is required. The average driving time is 1-4 hours daily. Occasional overnight stays and travel by air and/or train may be required. You're the right fit if: - You’ve acquired 3+ years of professional working experience in the IT technologies or electronics industry, preferably in a field or hospital-based service environment. Experience with patient monitoring, telemetry units, ventilators, and defibrillators highly preferred. - Your skills include network configuration and/or troubleshooting experience, and you have obtained the Cisco Certified Network Associate (CCNA) certification (or required to obtain within 6 months from beginning of employment). - You have a bachelor’s degree in computer science, electronics, biomedical, or other related disciplines or equivalent combination of education and above listed experience. - You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Field Service position. - You must be able to: - Work in an office/home office and/or remote setting, as well as in a hospital/healthcare environment; adhere to requirements. - Work flexible hours (based on business needs to include overtime, weekends, and on-call rotations). - Wear all required personal protective equipment. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is a field role. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. - Learn more about our business. - Discover our rich and exciting history. - Learn more about our purpose. - Learn more about our culture. Philips Transparency Details The hourly pay range for this position in KY is $32.00 to $49.00, plus overtime eligible. This role also includes field service incentive bonus plans, on-call pay, company fleet/car, training, and advancement opportunities. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive plan, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Louisville, KY. This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are seeking a highly organized and collaborative Regulatory Affairs Generalist to support a strategic pharmaceutical partnership and its associated development and commercial programs. This role is dedicated to providing end‑to‑end regulatory affairs support for partnered assets, working closely with internal teams and external alliance stakeholders to ensure regulatory excellence across clinical, submission, and post‑approval activities. Serving as a key regulatory interface within the partnership, the Regulatory Affairs Generalist plays a critical role in regulatory planning, documentation management, submission execution, and ongoing compliance with global regulatory requirements. The ideal candidate thrives in a dynamic, cross‑company environment, effectively balances multiple priorities, and brings strong communication, problem‑solving, and collaboration skills to support successful partnership outcomes. The Regulatory Affairs Generalist provides comprehensive support across clinical, submission, and post approval regulatory activities for assigned pharmaceutical products and development programs. This role works cross functionally to ensure operational excellence in regulatory planning, documentation management, submission execution, and compliance with global regulatory requirements. The ideal candidate thrives in a dynamic environment, is highly organized, and demonstrates strong communication and problem-solving skills. Key Responsibilities 1. Regulatory Archiving & Documentation Management - Maintain U.S. regulatory archive logs, including: - Recording new submissions. - Archiving regulatory authority correspondence. - Upload and manage correspondence from global partners for assigned programs. - Ensure proper indexing, version control, and compliance using Regulatory Information Management (RIM) systems, electronic document management systems (EDMS), or other applicable archiving tools. - Ensure records are complete, audit ready, and aligned with internal SOPs and regulatory expectations. 2. Clinical Regulatory Support - Maintain and update trackers for Form FDA 1572 waiver requests and other clinical regulatory documentation. - Conduct GLP reviews of study documentation on behalf of Regulatory Affairs to support IND level compliance. - Author 1572 waiver requests and support routine regulatory submissions for clinical investigators. - Attend cross functional clinical trial team meetings as the Regulatory Affairs representative, providing regulatory interpretation, updates, and risk assessments. 3. Regulatory Submission Preparation - Draft administrative components of regulatory submissions, including: - FDA forms - Cover letters - Submission metadata and other supporting documents - Build and organize electronic submission structures using RIM systems or industry standard submission planning tools. - Manage internal workflows and approval processes to ensure timely completion of submission components. - Coordinate submission package delivery through established publishing workflows and oversee communication with submission/publishing teams. 4. Global Regulatory Team (GRT) & Cross Functional Collaboration - Prepare presentation materials and slide decks for Global Regulatory Team (GRT) meetings, governance discussions, and alliance meetings. - Serve as the Regulatory Affairs representative in partner or alliance meetings for assigned products, providing updates and tracking action items. - Support ongoing cross functional program meetings as needed, ensuring regulatory deliverables and timelines remain on track. 5. Authoring & Reviewing Regulatory Submissions - Contribute to the drafting, review, and preparation of regulatory submissions across development phases, including: - FDA meeting requests - Briefing documents - Applications for special regulatory designations (e.g., Fast Track, Orphan Drug Designation) - IND submissions, amendments, and associated documentation - Ensure content is scientifically sound, consistent, clear, and aligned with regulatory standards and internal templates. 6. Post Approval Regulatory Maintenance - Prepare, review, and submit periodic post marketing regulatory reports for assigned products, including: - PADERs (Periodic Adverse Drug Experience Reports) - NDA Annual Reports - DSURs (Development Safety Update Reports) - PBRERs (Periodic Benefit Risk Evaluation Reports) - Maintain tracking and compliance with global post approval commitments, submission deadlines, and regulatory requirements. - Support lifecycle management activities to ensure continued product compliance. Skills: - Project management knowledge - Client-focused approach to work - Results orientation - Teamwork and collaboration skills - Consulting skills - Excellent interpersonal and intercultural communication skills, both written and verbal - Critical thinking and problem-solving skills - Proficiency in local language and extensive working knowledge of the English language Knowledge and Experience: 5+ years of related regulatory affairs experience in an industry-related environment Education: Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred. Other: Due to the client’s location, candidates located in the Eastern or Central time zones of the US or Canada are preferred. The ability to travel up to 20% may be required. #LI-LB1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.